cloprostenol and Glaucoma

The ocular delivery route presents a number of challenges in terms of drug administration and bioavailability. The low bioavailability following topical ophthalmic administration shows that there is a clear need for in-depth research aimed at finding both more efficacious molecules and formulations precisely targeted at the site of action. Continuous technological development will eventually result in improved bioavailability, lower dosages, reduced toxicity, fewer adverse effects, and thus better patient compliance and treatment efficacy. Technological development, as well as increasingly stringent quality requirements, help stimulate analytical progress. This is also clearly evident in the case of medicinal products used in the treatment of glaucoma, which are the subject of this review. Impurity profiling of PGF2α analogues, either in the pure substance or in the finished formulation, is a crucial step in assessing their quality. The development of specific, accurate and precise stability-indicating analytical methods for determining the content and related substances seems to be an important issue in relation to this tasks. A total of 27 official and in-house analytical methods are presented that are used for the analysis of latanoprost, travoprost and bimatoprost. The conditions for chromatographic separation with UV or MS/MS detection and the available results obtained during method validation are described. In addition, several aspects are discussed, with particular emphasis on the instability of the analogues in aqueous solution and the phenomenon of isomerism, which affects a potentially large number of degradation products.

Topics: Amides; Antihypertensive Agents; Cloprostenol; Drug Compounding; Glaucoma; Humans; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Tandem Mass Spectrometry

Glaucoma is a major cause of irreversible blindness worldwide. Reducing intraocular pressure (IOP) is currently the only approach to prevent further optic nerve head damage. Pharmacotherapy is the mainstay of treatment for glaucoma patients. In recent years, a significant milestone in glaucoma treatment has been a transition to prostaglandin analogs (PGAs) as the first line of drugs. The rapid shift from traditional β-blockers to PGAs is primarily due to their excellent efficacy, convenient once-a-day usage, better diurnal control of IOP, and systemic safety profiles. This review article aims to provide information regarding the various PGAs in practice and also the newer promising drugs.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Ophthalmology; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Travoprost

The objective of this meta-analysis was to evaluate the effect of prostaglandin analogues (PGA) on central corneal thickness (CCT) in patients with glaucoma. Key electronic databases were searched for randomized controlled trials (RCTs) involving the CCT effects of prostaglandin use for glaucoma. Primary outcome measures were the mean difference in the CCT measurement from baseline to the last available assessment. Intraocular pressure and other corneal changes were recorded as secondary. Efficacy estimates were measured by their weighted mean difference (WMD) with 95% confidence intervals (CI's) by using the random-effects model for primary and secondary outcomes Trial sequential analysis was used to determine if the current evidence was sufficient and conclusive. Eight RCTs met our inclusion criteria. A total of 879 patients were included. The overall effect showed that PGA's had a significant CCT lowering effect (WMD = -7.04, 95%CI: -10.07 to -4.00, P < 0.00001). We pooled results of 5 RCT's on Travoprost (WMD = -10.44, 95%CI: -16.80 to -4.08, P = 0.001), seven trials on Latanoprost (WMD = -4.73, 95% CI: -9.70 to 0.25, P = 0.06), and three trials on Bimatoprost (WMD = -11.88, 95%CI: -21.03 to -2.73, P = 0.01). The WMD across groups in >6 months of PGA use was -11.37 (95%CI: -17.17 to -5.58, P = 0.0001), and in <6 months of PGAs group was -8.35 (95% CI: -12.01 to -4.69, P < 0.00001), suggesting a longitudinal effect of PGAs on CCT. In conclusion, Bimatoprost and Travoprost caused a statistically significant reduction in the thickness of central cornea. Though only a few studies were included, the narrow confidence intervals and adequate sample size suggest that these findings are valid.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Glaucoma; Glaucoma, Open-Angle; Humans; Prostaglandins A; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Travoprost

Prostaglandin F2α analogs, commonly prescribed for glaucoma treatment, have been shown to induce side effects such as cutaneous hypertrichosis and hyperpigmentation. Therefore, these medications have theoretic applications in the treatment of alopecia and disorders of hypopigmentation. We reviewed the literature to find original studies assessing the use of prostaglandin F2α analogs in these settings. Studies and reports were analyzed in regards to androgenic alopecia, alopecia areata, chemotherapy-induced alopecia, vitiligo, and hypopigmented scarring. Based on the results of these studies, and consideration of pathophysiologic mechanism, the most promising applications for prostaglandin F2α analogs include androgenic alopecia, chemotherapy-induced alopecia, and alopecia areata concurrently treated with corticosteroids.

Topics: Adrenal Cortex Hormones; Alopecia; Amides; Animals; Bimatoprost; Cloprostenol; Dinoprost; Disease Models, Animal; Double-Blind Method; Drug Evaluation, Preclinical; Eyelashes; Glaucoma; Hair Follicle; Humans; Hyperpigmentation; Hypertrichosis; Hypopigmentation; Melanins; Mice; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic; Retrospective Studies; Single-Blind Method

Prostamide (prostaglandin ethanolamide) research emerged from two distinct lines of research: 1) the unique pharmacology of the antiglaucoma drug bimatoprost and 2) the discovery that endocannabinoid anandamide was converted by COX-2 to a series of electrochemically neutral prostaglandin (PG) ethanolamides. Bimatoprost pharmacology was found to be virtually identical to that of prostamide F2α. The earliest studies relied on comparison of agonist potencies compared with PGF2α and synthetic prostaglandin F2α (FP) receptor agonists. The subsequent discovery of selective and potent prostamide receptor antagonists (AGN 211334-6, as shown in Fig. 3) was critical for distinguishing between prostamide and FP receptor-mediated effects. The prostamide F2α receptor was then modeled by cotransfecting the wild-type FP receptor with an mRNA splicing variant (altFP4).Bimatoprost is now used therapeutically for treating both glaucoma and eyelash hypotrichosis. Bimatoprost also stimulates hair growth in isolated human scalp hair follicles. A strong effect is also seen in mouse pelage hair, where bimatoprost essentially halves the onset of hair regrowth and the time to achieve full hair regrowth in shaved mice. Beyond glaucoma and hair growth, bimatoprost has potential for reducing fat deposition. Studies to date suggest that preadipocytes are the cellular target for bimatoprost. The discovery of the enzyme prostamide/PGF synthase was invaluable in elucidating the anatomic distribution of prostamide F2α. High expression in the central nervous system provided the impetus for later studies that described prostamide F2α as a nociceptive mediator in the spinal cord. At the translational level, bimatoprost has already provided therapeutics in two distinct areas and the use of both prostamide agonists and antagonists may provide other useful medicaments.

Topics: Adipose Tissue; Amides; Animals; Antihypertensive Agents; Bimatoprost; Cloprostenol; Dinoprostone; Glaucoma; Hair; Humans

Glaucoma is the second leading cause of blindness globally, representing a significant public health concern. More than 60 million people are affected by glaucoma worldwide; as this population ages, the number is expected to increase. Glaucoma is a collection of heterogeneous diseases sharing common clinical characteristics. The goal of treatment is to prevent significant visual dysfunction through reduction of intraocular pressure (IOP).. This is a review of the current literature about combination therapeutic regimens for the reduction of IOP, focusing on the risk : benefit profile of a fixed-combination therapy using travoprost and timolol.. Since the debut of prostaglandin analogues in the 1990s, only modest innovation has occurred in glaucoma pharmacology. A growing body of research has established that the preservative benzalkonium chloride (BAK) might not be the benign contributor expected of excipient ingredients. Thus, BAK-free treatments were developed, with the goal of IOP reduction without furthering ocular surface disease symptoms. The BAK-free travoprost/timolol combination represents an important addition to glaucoma medication options and may fill an unmet need in this therapeutic arena.

Topics: Animals; Antihypertensive Agents; Benzalkonium Compounds; Cloprostenol; Drug Combinations; Glaucoma; Humans; Preservatives, Pharmaceutical; Timolol; Travoprost

Modern fixed-combination products simplify medication dose regimen without sacrificing their effectiveness.Potential benefits of the therapy with fixed-combination products are enhanced tolerability increased convenience,better compliance,cost and time economy and removal of the wash out effect. Regarding intraocular pressure lowering effect, fixed-combination agents are superior to monotherapy with the two medication components, with the exception of Duotrav that is not superior to travoprost action.Fixed-combination products are noninferior to concomitant administration of the two components of medication (nonfixed-combination agents) relative to their ocular hypotensive efficacy with the exception of Ganfort that is however inferior to concurrent administration of both the bimatoprost and timolol.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Brimonidine Tartrate, Timolol Maleate Drug Combination; Carbonic Anhydrase Inhibitors; Cloprostenol; Drug Combinations; Drug Therapy, Combination; Glaucoma; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Ophthalmic Solutions; Prostaglandins F, Synthetic; Quinoxalines; Sulfonamides; Thiazines; Thiophenes; Timolol; Travoprost; Treatment Outcome

The purpose of glaucoma treatment is to prevent progressive loss of optic nerve fibers and thereby to preserve the visual field. Because increased IOP is a primary risk factor in developing glaucoma, descrease its value below which may affect the optic is the antiglaucoma treatment target. This paper provides an overview of glaucoma treatment and the use of fixed combinations of topical prostaglandin analogues (PGA).

Topics: Amides; Antihypertensive Agents; Bimatoprost; Carbonic Anhydrase Inhibitors; Cloprostenol; Drug Combinations; Drug Therapy, Combination; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Optic Nerve; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Sulfonamides; Thiazines; Timolol; Travoprost; Treatment Outcome; Visual Fields

To report 2 cases of resolution of orbital fat pad prolapsus and deepening of the lid sulcus caused by topical bimatoprost therapy, and to review the literature.. This was a retrospective, observational chart review.. A 54-year-old man with normotensive glaucoma presented with recovery of left lower lid orbital fat pad prolapsus, deepening of the lid sulcus, and iris color and eyelash changes 8 months after initiation of bimatoprost therapy in his left eye (OS). After stopping bimatoprost, his eyelashes and the lower lid orbital fat pad partially regained their natural appearance at 2 months and 4 months, respectively. However, there was no improvement of the left upper eyelid deepening and the iris hyperpigmentation, even after 30 months. A 75-year-old man with unilateral pseudoexfoliative glaucoma had been treated with bimatoprost OS. Three months after initiation of the therapy, his examination showed recovery of the inferior and superomedial orbital fat pad prolapsus, a deep and prominent upper lid sulcus with eyelash changes, and iris hyperpigmentation OS. Five months after discontinuation of bimatoprost, the eyelashes and superomedial orbital fat pad improved. Twenty-four months later, the inferior orbital fat pad partially got its natural appearance back, but the upper lid sulcus was slightly more deep and prominent than the fellow right eye. There was no alteration in iris hyperpigmentation.. Clinicians and patients should be aware of these possible effects of topical bimatoprost therapy. These adverse effects may not be completely reversible after discontinuation of the medication.

Topics: Adipose Tissue; Administration, Topical; Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Eyelashes; Eyelids; Glaucoma; Humans; Iris; Male; Middle Aged; Treatment Outcome

Lipid structural derivatives (latanoprost, travoprost and bimatoprost) are ocular hypotensive agents that significantly lower ocular tension with more than 30% from baseline by once-daily dosing.Ocular tension reduction from baseline is statistically significantly greater for bimatoprost than for latanoprost at all time points measured. Compared with travoprost, ocular tension decrease was statistically greater with bimatoprost at 8AM and 12PM. This trend was also seen at 4PM and 8PM, even though the difference was not statistically significant at the former time point and borderline at the latter time point. The findings for latanoprost and travoprost indicate that these two agents are comparable in their ability to reduce ocular pressure with no statistically significant difference seen at any time point measured. There does not exist any evidence, excepting conjunctival hyperemia which has been lesser with latanoprost compared to both the bimatoprost and travoprost, that any of these 3 medications significantly differs with respect to their adverse effects.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Therapy, Combination; Evidence-Based Medicine; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Ophthalmic Solutions; Prostaglandins F, Synthetic; Travoprost; Treatment Outcome

To conduct a meta-analysis of randomised clinical trials (RCTs) in order to evaluate the development of conjunctival hyperaemia after the use of latanoprost versus travoprost and bimatoprost, in patients with ocular hypertension or glaucoma.. In order to identify the potentially relevant RCTs, a systematic literature retrieval was conducted in Medline, Embase and Cochrane Controlled Trials Register (1995-April 2007) databases The outcome measure was the appearance of conjunctival hyperaemia during the study. Statistical analyses included the calculation of odds ratio (OR) and its respective confidence interval, along with intertrial statistical heterogeneity. Publication bias was evaluated through a funnel plot, and a sensitivity analysis was also performed.. In total, 13 RCTs involving 2222 patients with ocular hypertension or glaucoma were included, five comparing latanoprost versus travoprost, seven comparing latanoprost versus bimatoprost and one comparing latanoprost versus travoprost and bimatoprost. The combined results showed that latanoprost produced lower occurrence of conjunctival hyperaemia than both travoprost (OR = 0.51; 95% CI 0.39 to 0.67, p<0.0001) and bimatoprost (OR = 0.32; 95% CI 0.24 to 0.42, p<0.0001). No significant heterogeneity was found between the included RCTs. There was no evidence of publication bias. In the sensitivity analysis performed, none of the clinical trials included in this meta-analysis has an important impact in the global estimation of OR.. According to available data, the use of latanoprost is associated with a lower incidence of conjunctival hyperaemia when compared with travoprost and bimatoprost in the treatment of patients with ocular hypertension or glaucoma.

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Conjunctival Diseases; Female; Glaucoma; Humans; Hyperemia; Latanoprost; Male; Middle Aged; Ocular Hypertension; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Randomized Controlled Trials as Topic; Travoprost

Topically administered bimatoprost 0.03%/timolol 0.5% ophthalmic solution (bimatoprost/timolol: Ganfort) comprises the synthetic prostamide bimatoprost (structurally related to prostaglandin F2 alpha) and the beta-adrenergic receptor antagonist timolol. Bimatoprost/timolol (one drop administered in the affected eye[s] once daily in the morning or evening) is an effective and well tolerated fixed combination for lowering intra-ocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension (OHT), including individuals uncontrolled on monotherapy with a beta-adrenergic receptor antagonist or prostaglandin analogue/prostamide.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Clinical Trials as Topic; Cloprostenol; Cost-Benefit Analysis; Drug Combinations; Glaucoma; Humans; Latanoprost; Ocular Hypertension; Prostaglandins F, Synthetic; Timolol

To asses the association of conjunctival hyperemia with the use of a fixed combination of latanoprost/timolol, through a systematic review and meta-analysis of clinical trials in patients with glaucoma.. A systematic review of published clinical trials of latanoprost/timolol and other competitors was conducted in Medline, Embasse and Cochrane Controlled Clinical Trials Register, between 2000 and 2007. Statistical analysis included calculation of the odds ratio (OR) with its 95% confidence interval (CI) using the fixed effects model of Mantel-Haenszel and the random effects model of Der Simonian and Laird. To assess the heterogeneity between trials the Cochrane Q test and the I(2) rate were calculated. The conjunctival hyperemia rates obtained were compared with the Chi-square test.. A total of 8 clinical trials comparing latanoprost/timolol fixed combination with different therapeutic options were found. As trial heterogeneity was moderate (Q: 14.64; df=7; p=0.041; I(2)= 52.2%) a random effects model was used. The final OR was 0.47 (CI 95%: 0.24-0.90); p = 0.024. The total conjunctival hyperemia incidence was 2.9% in the latanoprost/timolol group and 7.0% for the competitors (p<0.0001).. The use of a fixed combination of latanoprost/timolol is associated with a significant reduction (53%; CI 95%: 10%-76%) in the development of conjunctival hyperemia against the other compared options for the treatment of glaucoma.

Topics: Aged; Brimonidine Tartrate; Clinical Trials as Topic; Cloprostenol; Conjunctival Diseases; Cross-Over Studies; Drug Combinations; Drug Therapy, Combination; Glaucoma; Humans; Hyperemia; Latanoprost; Middle Aged; Ocular Hypertension; Odds Ratio; Prostaglandins F, Synthetic; Quinoxalines; Sulfonamides; Thiazines; Timolol; Travoprost

Bimatoprost is a neutral lipid, a fatty acid amide that pharmacologically acts in both its paternal amide form and through its hydrolysis product (active free fatty acid of bimatoprost). Hypotensive ocular efficacy of bimatoprost is significantly superior to that of timolol and latanoprost. Mean ocular pressure decreases as well as percentages of reaching and sustaining the low targeting ocular pressures are higher comparing with travoprost. Conjunctival hyperemia produced by bimatoprost is statistically greater than that caused by timolol, latanoprost and travoprost; nevertheless it is well tolerated and mild in severity. Bimatoprost prostamide lowers ocular tension significantly and clinically relevant in patients uncontrolled with latanoprost; that is why bimatoprost can be used as additive or replacement therapy in patients who already receive maximal tolerated dose of latanoprost.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Therapy, Combination; Evidence-Based Medicine; Glaucoma; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic; Timolol; Travoprost; Treatment Outcome

To assess the cost-efficacy of three fixed-combination glaucoma treatments currently available in Spain [bimatoprost with timolol (BT)- Ganfort, latanoprost with timolol (LT)- Xalacom, and travoprost with timolol (TT)- DuoTrav].. Because no studies are available that give a direct comparison of these drugs, a systematic review was carried out to assess their efficacy. Resource consumption and costs were estimated using a model of usual local practice. For each of the three drugs, average and incremental cost-efficacy ratios were determined in terms of euros per percentage point of reduction of intraocular pressure (IOP) over a three-month period.. BT reduced IOP by 35.1%, LT by 35.0% and TT by 34.7%. Average cost-efficacy was estimated to be euro 5.34 per percentage point of IOP reduction with BT, euro 5.40 with LT, and euro 5.45 with TT. Incremental cost-efficacy (incremental cost per incremental percentage point of IOP reduction) was estimated to be euro 94.65 for LT vs. TT, and was negative for BT vs. TT and BT vs. LT, since in both cases BT was more efficacious and less expensive.. Compared to travoprost/timolol and latanoprost/timolol, bimatoprost/timolol appears to be the most economic alternative, with equal or better efficacy and safety results.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cost-Benefit Analysis; Drug Combinations; Glaucoma; Humans; Latanoprost; Middle Aged; Prostaglandins F, Synthetic; Timolol; Travoprost

Topics: Antihypertensive Agents; Cloprostenol; Drug Therapy, Combination; Glaucoma; Humans; Intraocular Pressure; Lasers; Ophthalmic Solutions; Prostaglandins F; Trabeculectomy; Travoprost

Fixed combinations represent a combination of two ocular hypotensive agents into one single ophthalmic solution. Current commercially available fixed combinations used in glaucoma treatment include Combigan, Cosopt, Xalcom, Duotrav and Ganfort. Statistically significant superiority of the ocular hipotensive efficacy of the fixed combinations vs monotherapy with the two individual constituents is present connected with Cosopt and Xalcom. It also exists vs timolol ophthalmic solution relative to Combigan, Duotrav and Ganfort but is missing within these fixed combinations vs brimonidine, travatan and bimatoprost respectively. A slight reduction, that is clinically and statistically insignificant relative to fixed combination efficacy vs the nonfixed combinations (e.g. concomitant but separate administration of the two individual components) is acceptable when this is balanced by potential benefits of the fixed combinations therapy (improved tolerability and convenience,increased compliance,cost and time economies,decreased washout effect and reduced exposure to preservatives).

Topics: Amides; Antihypertensive Agents; Bimatoprost; Brimonidine Tartrate; Cloprostenol; Drug Combinations; Drug Therapy, Combination; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Ophthalmic Solutions; Prostaglandins F, Synthetic; Quinoxalines; Sulfonamides; Thiophenes; Timolol; Travoprost; Treatment Outcome

When a single medication does not adequately control intraocular pressure, additional intraocular hypotensive agents are often added to the therapeutic regime. However, regimen complexity has been associated with reduced patient compliance. Treatment with a fixed combination may, therefore, increase compliance as a result of simplifying the dosage regimen. Bimatoprost/timolol fixed combination (BTFC) combines two clinically effective agents that decrease elevated intraocular pressure by independent mechanisms. In two clinical studies, BTFC was more effective than its individual components. Furthermore, in a non-inferiority study BTFC has been shown to be as effective as the association of its individual components. BTFC was clinically effective and generally well tolerated, with no unexpected adverse reactions reported for the BTFC compared with those reported for bimatoprost or timolol monotherapies.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Blood Pressure; Cloprostenol; Drug Combinations; Glaucoma; Humans; Lipids; Ocular Hypertension; Timolol; Treatment Outcome

To compare the efficacy of latanoprost, bimatoprost and travoprost for lowering IOP in patients with glaucoma.. In order to carry out this meta-analysis, randomized trials (2001-2004) were identified on Medline and EMBASE using the following key words: glaucoma, ocular hypertension (OHT), randomization, trial, latanoprost, bimatoprost and travoprost. The studies had to compare at least two prostaglandin analogues as mono-therapy. Cross-over experimental designs were excluded. The main outcome measure was IOP at final visit. Statistical analyses included random effects, pooled estimates of treatment effects, tests for publication bias, and random-effects models to obtain adjusted treatment effects on final IOP after lowering for baseline IOP, and duration of follow-up. Random effects Poisson regression models were used to estimate the adjusted effects of treatments on response rates (IOP < 18 mmHg).. Nine studies were used in the analysis. Patient mean age varied from 56.7 to 68.8 years and baseline IOP ranged from 22.3 to 26.5 mmHg. Three hundred and seventy-eight patients were treated with bimatoprost, 385 with travoprost and 555 with latanoprost. Patients treated with travoprost and bimatoprost had lower IOP levels at the end of follow-up (-0.98 mmHg [95% CI: -2.08; 0.13; p = 0.08] and -1.04 mmHg [95% CI: -2.11;0.04; p = 0.06], respectively) than those treated with latanoprost. The combined effect of newer prostaglandin analogues (bimatoprost/travoprost) was an adjusted decrease of 1.00 mmHg [95% CI: -1.91;-0.10], p = 0.03], or a 17% higher adjusted response rate (Incidence Rate Ratio 1.17, 95% CI, 1.00-1.35, p = 0.04), compared to latanoprost.. Travoprost and bimatoprost may have greater efficacy in lowering IOP for patients with OHT or glaucoma.

Topics: Administration, Topical; Aged; Amides; Bimatoprost; Cloprostenol; Confidence Intervals; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Lipids; Male; Middle Aged; Ophthalmic Solutions; Probability; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Randomized Controlled Trials as Topic; Risk Assessment; Severity of Illness Index; Tonometry, Ocular; Travoprost; Treatment Outcome

The aim of this study was to evaluate the cost effectiveness of glaucoma treatment with bimatoprost compared with other intraocular pressure (IOP)-lowering medications in adult patients with chronic glaucoma or ocular hypertension (IOP of between 22 mm Hg and 34 mm Hg), from a US healthcare payers' perspective.. Estimated yearly costs and cost per treatment success for 0.03% bimatoprost once daily (Lumigan) were compared with 0.5% timolol twice daily (generic), 0.005% latanoprost once daily (Xalatan) and the fixed combination of 0.5% timolol and 2.0% dorzolamide twice daily (Cosopt). The model was based on year 2003 medical resource costs (physician visits and drug acquisition costs) and treatment success rates from published clinical trials. The clinical measure utilised was the percentage of patients achieving target IOPs.. A higher percentage of patients achieved target IOPs with bimatoprost than with each of the other medications. At most target pressures, the cost per treatment success for patients starting treatment on bimatoprost was less than that for patients started on other drugs. This was true despite that, when looking at costs alone, the estimated yearly costs for bimatoprost (averaged over both patient success and patient failures) were similar to or greater than those for the other drugs. The greatest differences in cost per treatment success were seen at target pressures < or =15 mm Hg. For example, at a target pressure of 13 mm Hg, the cost per treatment success based on the model was 9238-10,229 US dollars for bimatoprost, 23,218 US dollars for timolol, 21,943 US dollars for latanoprost and 16,034 US dollars for timolol/dorzolamide. The incremental cost of achieving additional clinical success for bimatoprost ranged from 800 US dollars to 1,700 US dollars versus generic timolol, and from 300 US dollars to 3,100 US dollars versus timolol/dorzolamide. Bimatoprost was more effective and less costly than latanoprost.. In our simplified model of cost per treatment success based on responder rates at varying IOPs, the greater efficacy of bimatoprost resulted in a cost per treatment success that was generally lower for bimatoprost than for timolol, latanoprost or timolol/dorzolamide. This was most pronounced at target pressures <15 mm Hg.

Topics: Adrenergic beta-Antagonists; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cost-Benefit Analysis; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Lipids; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic; Timolol; Treatment Outcome; United States

Travoprost 0.004%/timolol 0.5% fixed combination (travoprost/timolol) is a once-daily eyedrops solution comprising the prostaglandin F(2alpha) analogue travoprost and the beta-adrenoceptor antagonist timolol. It is indicated for the treatment of patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-adrenoceptor antagonists or prostaglandin analogues. Once-daily travoprost/timolol had generally similar efficacy to travoprost plus timolol and was more effective than travoprost or timolol monotherapy in reducing intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension in randomised, well designed studies. Both travoprost/timolol and latanoprost plus timolol maintained IOP control, and travoprost/timolol was shown to be noninferior to latanoprost/timolol in randomised, well designed studies. Travoprost/timolol was generally well tolerated, with a tolerability profile similar to those of travoprost plus timolol, travoprost or timolol monotherapy and latanoprost plus timolol. The majority of adverse events, such as ocular hyperaemia, were mild and resolved with or without treatment.

Topics: Cloprostenol; Drug Combinations; Glaucoma; Humans; Patient Compliance; Timolol; Travoprost

In the article the recent research on the biology of corneal stroma and biological impact of topical prostaglandin analogues on this tissue, were presented. The outcome of some studies, regarding influence of this class of antiglaucoma medication on central corneal thickness (CCT), were included. The impact of CCT on the readings of intraocular pressure and the aspect of diurnal fluctuations of CCT were also emphasized.

Topics: Administration, Topical; Cloprostenol; Cornea; Glaucoma; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins F, Synthetic; Travoprost

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Glaucoma; Humans; Intraocular Pressure; Lipids

Bimatoprost is a pharmacologically unique and highly efficacious anti-glaucoma agent. It appears to mimic the activity of the prostamides, which are biosynthesized from the natural endocannabinoid anandamide by the enzyme cyclo-oxygenase 2 (COX-2). Bimatoprost has also been suggested to lower intraocular pressure by behaving as a prodrug or, alternatively, by stimulating FP receptors directly. These three distinctly different hypotheses for the mechanism of bimatoprost activity are discussed in the light of current evidence.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Glaucoma; Humans; Intraocular Pressure; Lipids; Prodrugs; Receptors, Prostaglandin

The aim of glaucoma therapy is to preserve vision by reducing intraocular pressure (IOP). Following recent National Eye Institute sponsored studies, it is becoming increasingly apparent that every mmHg of extra IOP lowering counts. Bimatoprost is the newest and most effective addition to the physician's armamentarium of ocular hypotensive drugs. Direct clinical comparisons have demonstrated that it is more efficacious than the prostaglandin (PG) FP receptor agonist prodrugs, latanoprost and travoprost, as well as a beta-adrenoceptor antagonist, timolol, alone or in fixed combination with the carbonic anhydrase inhibitor, dorzolamide. Moreover, patients that are refractory to latanoprost therapy may be successfully treated with bimatoprost. Such evidence provides support, at the clinical level, for the contention that bimatoprost is pharmacologically distinct from PG FP receptor agonist prodrugs. Bimatoprost is a structural analog of PGF2alpha-ethanolamide (prostamide F2alpha), which is formed from the endocannabinoid anandamide by a biosynthetic pathway involving cyclooxygenase-2 (COX-2). Their pharmacology is remarkably similar, such that bimatoprost may be regarded as a prostamide mimetic. The target receptor for bimatoprost and the prostamides appears unique and unrelated to PG- and endocannabinoid-sensitive receptors. Extensive ocular distribution/metabolism studies in non-human primates demonstrate that bimatoprost is not a prodrug, it remains essentially intact. Its profound ocular hypotensive effects may, therefore, be attributed to its prostamide-mimetic properties.

Topics: Amides; Animals; Antihypertensive Agents; Bimatoprost; Clinical Trials as Topic; Cloprostenol; Glaucoma; Humans; Intraocular Pressure; Lipids; Time Factors; Treatment Outcome

In the first part of the article the main information and recent research on the uveoscleral outflow pathway, including its morphology and physiology were presented. The structure of extracellular matrix of ciliary muscle and the changes of it, that are induced by prostaglandins, resulting in decreasing intraocular pressure were emphasized. In the second part biochemical characteristics of prostaglandin analogues, using nowadays were presented. Their efficacy in reducing intraocular pressure and safety profile were described.

Topics: Amides; Bimatoprost; Cloprostenol; Dinoprost; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Lipids; Prostaglandins F; Prostaglandins F, Synthetic; Receptors, Prostaglandin; Travoprost; Treatment Outcome

The prostaglandin derivatives are thought to lower intraocular pressure (IOP) primarily by increasing uveoscleral outflow. The ocular side effect, hyperemia, appears to occur via a secondary, unrelated mechanism. Variations in the IOP-lowering effect and incidence of hyperemia associated with these drugs are a function of their different chemical structures. Among the currently approved prostaglandin derivatives, hyperemia occurs in as many as 50% of patients treated with travoprost and as few as 5% of patients treated with latanoprost. The side effect of hyperemia may be of concern to the ophthalmologist for at least 2 reasons: hyperemia may compromise the outcome of filtration surgery, and it may represent a cosmetic problem to the patient thereby leading to non-compliance. The extent to which hyperemia may contribute to patient noncompliance and the effect of administration of the prostaglandin derivatives on outcome of filtration surgery remain to be determined. Until more definitive data are available, when selecting a prostaglandin analogue for ocular hypotensive therapy, it seems prudent to choose an agent with a low incidence of hyperemia.

Topics: Administration, Topical; Cloprostenol; Conjunctiva; Glaucoma; Humans; Hyperemia; Incidence; Intraocular Pressure; Latanoprost; Ocular Hypertension; Prostaglandins; Prostaglandins F, Synthetic; Travoprost

Prostaglandin analogs are a novel class of intraocular-lowering medications used primarily for the treatment of glaucoma. These topical medications reduce intraocular pressure primarily by enhancing uveoscleral outflow. The recent literature has enhanced our understanding of the mechanism of action, efficacy, and safety of these agents and has allowed us to better understand the differences between the three commonly used once-daily medications.

Topics: Administration, Topical; Amides; Bimatoprost; Cloprostenol; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Lipids; Ocular Hypertension; Prostaglandins; Prostaglandins F, Synthetic; Safety; Travoprost

Bimatoprost (Lumigan [Allergan, Inc, Irvine CA]) and travoprost (Travatan [Alcon, Ft Worth, TX]) are two new intraocular pressure (IOP)-lowering drugs for use in patients with glaucoma and ocular hypertension. This review evaluates recent studies comparing these new drugs with timolol and with latanoprost. In each study, the statistical analyses support the conclusion that these agents were more effective than timolol and as effective as latanoprost in terms of their ability to reduce IOP. The side effect profiles for bimatoprost, latanoprost, and travoprost were similar, but with statistically higher occurrences of hyperemia and eyelash growth for bimatoprost or travoprost versus latanoprost or timolol.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Lipids; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic; Timolol; Travoprost

Despite treatment, glaucoma patients may still suffer vision loss because of inadequate control of intraocular pressure or late presentation. This article reviews the latest evidence supporting a reappraisal of first-line treatment in the management of glaucoma, including a review of latanoprost, recently approved for first-line treatment of glaucoma and ocular hypertension.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Brimonidine Tartrate; Cloprostenol; Dinoprost; Drug Therapy, Combination; Glaucoma; Humans; Latanoprost; Lipids; Prostaglandins; Prostaglandins F, Synthetic; Quinoxalines; Sulfonamides; Thiophenes; Travoprost

Travoprost, a highly selective and potent analogue of the prostaglandin PGF(2)(alpha), has recently been approved and marketed as a topical ocular hypotensive agent for the treatment of ocular hypertension and glaucoma. Following absorption into the eye, the free acid form of travoprost interacts with the endogenous FP prostanoid receptor to enhance aqueous humor outflow and lower intraocular pressure (IOP). Travoprost is distinguished from other marketed prostaglandin analogues in that it is a full agonist at the prostaglandin receptor. It is also highly selective with little or no affinity for other prostanoid or non-prostanoid receptors in the eye. Travoprost provides robust lowering of IOP with little diurnal fluctuation and results in low target pressures in a large percentage of patients. In controlled clinical trials, travoprost 0.004% o.d. used as monotherapy produced greater IOP reduction than timolol 0.5% b.i.d. and equal or greater reduction than latanoprost 0.005%o.d. Travoprost 0.004% was also shown to be an effective adjunctive agent offering an additional 5 - 7 mmHg IOP reduction in patients inadequately controlled on timolol 0.5%. Subgroup analysis of a large Phase III trial revealed travoprost 0.004% to be significantly more effective at lowering IOP in African American patients by almost 2 mmHg compared to non-African Americans. Moreover, a higher percentage of African American patients responded to travoprost 0.004% and reached lower target pressures than with either latanoprost 0.005% or timolol 0.5%. Travoprost is a very stable compound, maintaining its efficacy following exposure to extremely low and high temperatures, repeated freezing and thawing and exposure to light. Throughout all clinical trials, travoprost was found to be safe and well-tolerated with very few (< 5%) discontinuations due to adverse events. Travoprost 0.004% represents a clinically significant advance for the treatment of glaucoma and ocular hypertension, offering superior IOP reduction and diurnal control, especially among African American patients, in a safe, well-tolerated, stable formulation.

Topics: Adrenergic beta-Antagonists; Antihypertensive Agents; Clinical Trials as Topic; Cloprostenol; Dose-Response Relationship, Drug; Drug Therapy, Combination; Glaucoma; Humans; Intraocular Pressure; Ocular Hypertension; Racial Groups; Receptors, Prostaglandin; Timolol; Travoprost

Bimatoprost, a synthetic analogue of endogenous prostamides, is in development as a topical ocular hypotensive agent for the treatment of glaucoma and ocular hypertension. Prostamides are a newly discovered class of compounds that have been shown to have potent ocular hypotensive activity in the laboratory. Bimatoprost mimics the endogenous prostamides by lowering intraocular pressure (IOP). Bimatoprost provides outstanding control of IOP throughout the day, and a high percentage of patients receiving bimatoprost achieve the low target pressures important for clinical success. In controlled clinical trials, bimatoprost 0.03% given once daily has displayed efficacy superior to timolol 0.5% given twice daily, the current standard for therapy. Analysis of pooled six month data from two large Phase III trials demonstrated that mean IOP was consistently 2 - 3 mmHg lower with bimatoprost q.d. than with timolol b.i.d. Bimatoprost 0.03% q.d. has also been shown to provide significantly better diurnal IOP control than latanoprost 0.005% q.d., probably the most efficacious topical medication currently available. Patients receiving bimatoprost q.d. were more likely than timolol or latanoprost patients to achieve low target pressures. In all clinical evaluations, bimatoprost q.d. has been demonstrated to be safe and well-tolerated. Bimatoprost will likely be available for clinical use in 2001 and it has great potential to be superior to all other medications in IOP-lowering efficacy. It is anticipated that bimatoprost will have an important role in therapy for glaucoma and ocular hypertension.

Topics: Amides; Bimatoprost; Clinical Trials as Topic; Cloprostenol; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Lipids; Prostaglandins F, Synthetic; Timolol

Bimatoprost (Lumigan) is a pharmacologically unique and highly efficacious ocular hypotensive agent. It appears to mimic the activity of a newly discovered family of fatty acid amides, termed prostamides. One biosynthetic route to the prostamides involves anandamide as the precursor. Bimatoprost pharmacology has been extensively characterized by binding and functional studies at more than 100 drug targets, which comprise a diverse variety of receptors, ion channels, and transporters. Bimatoprost exhibited no meaningful activity at receptors known to include antiglaucoma drug targets as follows: adenosine (A(1-3)), adrenergic (alpha(1), alpha(2), beta(1), beta(2)), cannabinoid (CB(1), CB(2)), dopamine (D(1-5)), muscarinic (M(1-5)), prostanoid (DP, EP(1-4), FP, IP, TP), and serotonin (5HT(1-7)). Bimatoprost does, however, exhibit potent inherent pharmacological activity in the feline iris sphincter preparation, which is prostamide-sensitive. Bimatoprost also resembles the prostamides in that it is a potent and highly efficacious ocular hypotensive agent. A single dose of bimatoprost markedly reduces intraocular pressure in dogs and laser-induced ocular hypertensive monkeys. Decreases in intraocular pressure are well maintained for at least 24 hr post-dose. Human studies have demonstrated that systemic exposure to bimatoprost is low and that accumulation does not occur. The sclera is the preferred route of accession to the eye. The high scleral permeability coefficient Papp is a likely contributing factor to the rapid onset and long-acting ocular hypotensive profile of bimatoprost.

Topics: Amides; Animals; Antihypertensive Agents; Bimatoprost; Cloprostenol; Glaucoma; Intraocular Pressure; Iris; Lipids; Muscle, Smooth; Ocular Hypertension

Bimatoprost is a new ocular hypotensive agent that lowers intraocular pressure (IOP) in normal, ocular hypertensive, and glaucomatous eyes. Its mechanism of action has been studied in normal human subjects. Bimatoprost mildly stimulates the rate of aqueous humor flow during the day (13%) and at night (14%). Its ocular hypotensive action is due primarily to a 26% reduction in the tonographic resistance to outflow. Thus, bimatoprost enhances the pressure-sensitive outflow pathway. Additional beneficial effects may include an increase in the rate of flow via the pressure-insensitive outflow pathway (sometimes called the "uveoscleral outflow pathway") and a lowering of the extraocular recipient pressure (sometimes called "episcleral venous pressure"). Reduction of tonographic resistance to aqueous humor outflow reduces steady-state IOP, an effect that is beneficial for the treatment of glaucoma. In addition to its effect on steady-state IOP, reduction of resistance allows the eye to recover more quickly from transient IOP elevations. The former effect is common to all ocular hypotensive drugs, but the latter effect is an exclusive property of drugs that reduce outflow resistance, such as bimatoprost.

Topics: Amides; Animals; Anterior Chamber; Antihypertensive Agents; Aqueous Humor; Bimatoprost; Cloprostenol; Glaucoma; Humans; Intraocular Pressure; Lipids; Ocular Hypertension

To compare the efficacies of latanoprost 0.005%, travoprost 0.004%, and tafluprost 0.0015% in reducing diurnal intraocular pressure (IOP) fluctuations in patients with newly diagnosed primary open-angle glaucoma (POAG).. In this prospective randomized clinical trial, 60 patients who were newly diagnosed with POAG were divided into three equal groups. Patients were examined at presentation and at second and sixth weeks. Diurnal phasing of IOP was conducted using a calibrated Goldmann applanation tonometer. IOP measurements were recorded from 8:00 am to 9:00 am, from 3:00 pm to 4:00 pm, and from 7:00 pm to 8:00 pm.. The study groups were distributed similarly in terms of age and gender (. Latanoprost, travoprost, and tafluprost show a similar effectiveness in reducing the mean IOP and the diurnal IOP fluctuation in POAG. Importantly, the three drugs have comparable tolerability with insignificant differences regarding the pattern of their side effects.

Topics: Adult; Aged; Antihypertensive Agents; Cloprostenol; Double-Blind Method; Glaucoma; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Middle Aged; Ophthalmic Solutions; Prospective Studies; Prostaglandins F; Prostaglandins F, Synthetic; Travoprost; Treatment Outcome

To compare the effect of bimatoprost and the fixed combination latanoprost-timolol (LTFC) on 24-hour systolic (SBP) and diastolic (DBP) blood pressure and on 24-hour ocular perfusion pressure (OPP).. 200 patients with glaucoma or ocular hypertension, controlled on the unfixed combination of latanoprost and timolol or eligible for dual therapy being not being fully controlled on monotherapy were enrolled in a randomized, double-masked, placebo-controlled, multicentre clinical trial. They were randomized to LTFC (8 a.m.) or bimatoprost (8 p.m.) and received 24-hour IOP curve at baseline, 6 and 12 weeks (supine and sitting position IOPs were recorded at 8 p.m., midnight, 5 a.m., 8a.m., noon and 4 p.m.). Holter 24-hour blood pressure curve was obtained between weeks 2 and 12. SBP, DBP, OPP were calculated and compared with ANOVA. Rates of diastolic OPP (DPP)≤50, ≤40, ≤30 mmHg in the 2 groups were calculated and compared using Fisher's test.. Mean baseline SBP and DBP were 136.5±18.3 vs 134.2±20.1 mmHg (p=0.1) and 79.1±10.2 vs 78.2±10.1 mmHg (p=0.4) in the bimatoprost and LTFC groups respectively. Holter SBP was significantly higher for bimatoprost (135.1 mmHg vs 128.1 mmHg, p=0.04), while no statistically significant difference in DBP was found. DPP was similar in the 2 groups, and proportions of patients with at least one value of the 24-hour curve≤50, ≤40, ≤30 mmHg were 94%, 86%, 41% respectively.. Bimatoprost and LTFC had similar DBPs and OPPs; SBP was significantly lower with LTFC. In this study, the percentage of "dippers" was considerably higher than the one described in previous studies on the role of perfusion pressure in glaucoma.. NCT02154217, May 21, 2014.

Topics: Adult; Aged; Amides; Analysis of Variance; Antihypertensive Agents; Bimatoprost; Blood Pressure; Cloprostenol; Double-Blind Method; Drug Therapy, Combination; Female; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Prostaglandins F, Synthetic; Timolol

The efficacy of lowering intraocular pressure (IOP) and safety of switching to travoprost/timolol fixed combination ophthalmic solution (Duotrav(®), Alcon Laboratories, Inc., Fort Worth, TX, USA) in patients with primary open-angle glaucoma, normal tension glaucoma or ocular hypertension undergoing prostaglandin analog (PGA) monotherapy was investigated.. Patients treated with travoprost, latanoprost, tafluprost, or bimatoprost for ≥3 months and requiring additional medication were switched to Duotrav without washout. Baseline IOP was calculated from measurements at two visits during PGA monotherapy. IOP reductions at 4, 8, and 12 weeks after switching to Duotrav and adverse events were assessed.. Of 162 patients enrolled, 157 patients (96.9%) with ≥4 weeks of follow-up after switching to Duotrav were analyzed. The mean IOP decreased significantly (baseline = 16.3 ± 3.1 mmHg; 4 weeks = 14.6 ± 3.1 mmHg, 8 weeks = 14.7 ± 3.3 mmHg, 12 weeks = 14.6 ± 3.2 mmHg; all P < 0.0001). When study eyes were divided into three groups according to baseline IOP (≥19 mmHg: 33 eyes, 21.0%; ≥15 to <19 mmHg: 78 eyes, 49.7%; <15 mmHg: 46 eyes, 29.3%), all groups showed significant IOP reductions (P = 0.0324 ~ P < 0.0001) after switching to Duotrav. Twenty-seven of 166 patients (16.3%) in the safety analysis experienced adverse events and 26/166 patients (15.7%) experienced adverse events, for which a relationship to Duotrav could not be ruled out. Adverse events in five patients led to treatment discontinuation (eye pruritus; eye irritation; increased blood pressure and rash; increased blurred vision; deepening of the eyelid sulcus and blepharoptosis). Twelve weeks after treatment switching, eyelash changes, blepharal pigmentation and deepening of the eyelid sulcus occurred in 42 (26.8%), 29 (18.5%), and 13 (8.3%) cases, respectively, among 157 patients with follow-up. There was no significant worsening from baseline for superficial punctate keratopathy (SPK) or conjunctival hyperemia after switching (SPK score: baseline = 0.58 ± 1.31; 12 weeks = 0.92 ± 1.76, P = 0.1819; conjunctival hyperemia score: baseline = 0.41 ± 0.64; 12 weeks = 0.49 ± 0.63, P = 0.3774).. Our findings confirm that switching to Duotrav(®) in PGA monotherapy patients shows IOP-lowering effect with minimal safety concerns.. Japan Association of Health Service and Alcon Japan. Ltd.. UMIN Clinical Trials Registry identifier, UMIN000007028.

Topics: Adult; Aged; Aged, 80 and over; Cloprostenol; Drug Combinations; Drug Substitution; Female; Glaucoma; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Japan; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Timolol; Tonometry, Ocular

To evaluate the safety of two commercially available formulations of bimatoprost eye drops: 0.03 and 0.01% ophthalmic solutions.. This was a randomized, prospective, parallel-group, open-label, cohort study. A total of 60 glaucoma patients (60 eyes) under bimatoprost 0.03% monotherapy since at least 1 year were enrolled. Selected patients were randomized to receive a single drop of bimatoprost 0.01% (n=30) or bimatoprost 0.03% (n=30) ophthalmic solutions for 12 months. Statistical analysis was performed using paired t-test and repeated measures ANOVA test.. Global clinical score (the sum of pruritus, stinging/burning, blurred vision, sticky eye sensation, eye dryness sensation, and foreign body sensation) significantly decreased in the bimatoprost 0.01% group from baseline 4.7 ± 3.8 to 2.9 ± 2.3 (P < 0.001) and 2.5 ± 2.0 (P < 0.001) at 6-month and 12-month follow-ups, respectively. Comparison between groups showed differences at both follow-up visits (P = 0.003 and P < 0.001, respectively). In vivo confocal microscopy revealed a significant increase in goblet cell density in the bimatoprost 0.01% group compared with the bimatoprost 0.03% group (P<0.001 at both follow-up visits). All functional parameters and conjunctival hyperemia improved in the bimatoprost 0.01% group at each follow-up visit (P < 0.05) and in comparison with bimatoprost 0.03% (P < 0.05).. The results of this trial suggest that bimatoprost 0.01% eye drops seem to decrease the ocular discomfort with respect to bimatoprost 0.03% eye drops.

Topics: Amides; Analysis of Variance; Antihypertensive Agents; Bimatoprost; Cloprostenol; Eye Pain; Glaucoma; Humans; Intraocular Pressure; Microscopy, Confocal; Middle Aged; Prospective Studies; Tears; Visual Acuity

Improving adherence to ocular hypertension (OH)/glaucoma therapy is highly likely to prevent or reduce progression of optic nerve damage. The present study used a behaviour change counselling intervention to determine whether education and support was beneficial and cost-effective in improving adherence with glaucoma therapy.. A randomised controlled trial with a 13-month recruitment and 8-month follow-up period was conducted. Patients with OH/glaucoma attending a glaucoma clinic and starting treatment with travoprost were approached. Participants were randomised into two groups and adherence was measured over 8 months, using an electronic monitoring device (Travalert® dosing aid, TDA). The control group received standard clinical care, and the intervention group received a novel glaucoma education and motivational support package using behaviour change counselling. Cost-effectiveness framework analysis was used to estimate any potential cost benefit of improving adherence.. Two hundred and eight patients were recruited (102 intervention, 106 control). No significant difference in mean adherence over the monitoring period was identified with 77.2% (CI, 73.0, 81.4) for the control group and 74.8% (CI, 69.7, 79.9) for the intervention group (p = 0.47). Similarly, there was no significant difference in percentage intraocular pressure reduction; 27.6% (CI, 23.5, 31.7) for the control group and 25.3% (CI, 21.06, 29.54) for the intervention group (p = 0.45). Participants in the intervention group were more satisfied with information about glaucoma medication with a mean score of 14.47/17 (CI, 13.85, 15.0) compared with control group which was 8.51 (CI, 7.72, 9.30). The mean intervention cost per patient was GB£10.35 (

Topics: Aged; Aged, 80 and over; Analysis of Variance; Antihypertensive Agents; Cloprostenol; Counseling; Female; Glaucoma; Health Care Costs; Humans; Intraocular Pressure; Male; Medication Adherence; Middle Aged; Ocular Hypertension; Patient Education as Topic; Patient Satisfaction; Patient-Centered Care; Travoprost

To compare the toxicity effect of polyquaternium (PQ) and benzalkonium chloride (BAK) preservation of travoprost on the ocular surface.. This prospective study included 44 eyes of 44 patients with newly diagnosed glaucoma. Twenty-two patients used PQ-preserved travoprost (PQ group) and 22 patients used BAK-preserved travoprost (BAK group). To investigate the effect on the ocular surface, conjunctival impression cytology (IC) was performed at baseline and the 1- and 6-month follow-up visits. Additionally, the ocular surface disease index (OSDI) questionnaire, Schirmer I test, and tear break-up time (TBUT) measurement were administered at baseline, and at 1-, 3-, and 6-month follow-up visits.. While both groups showed statistically significant IC grade increases at 1 and 6 months when compared with baseline measurements, IC grades were significantly higher for patients using PQ-preserved travoprost compared with patients using BAK-preserved travoprost. The Schirmer I test and TBUT scores were not statistically significant between group 1 and BAK group at baseline and at 1-, 3-, and 6-month visits (P>0.05). OSDI scores did not statistically differ at baseline and the 1-month measurements between the 2 groups (P>0.05), but the 3- and 6-month OSDI scores were significantly higher for BAK group (P=0.001). Differences in OSDI and Schirmer I test scores were statistically significant at 1, 3, and 6 months in both groups as compared with baseline values (P<0.05). Statistically significant differences in the TBUT scores were seen for both groups at 3 and 6 months, while BAK group, but not PQ group, had insignificant score differences at 1 month as compared with baseline values of PQ group (P=0.083).. PQ-preserved travoprost was found to be safer and better-tolerated than BAK-preserved travoprost. PQ-preserved travoprost provided better ocular surface comfort, and therefore a better patient experience, which would likely result in higher treatment compliance.

Topics: Benzalkonium Compounds; Cloprostenol; Cornea; Cytological Techniques; Female; Glaucoma; Humans; Male; Middle Aged; Polymers; Preservatives, Pharmaceutical; Prospective Studies; Surface Properties; Travoprost

To compare the 24-h intraocular pressure (IOP) control obtained with the bimatoprost-timolol fixed combination (BTFC) versus latanoprost in newly diagnosed, previously untreated exfoliation syndrome (XFS) or exfoliative glaucoma (XFG) patients with baseline morning IOP greater than 29 mm Hg.. One eye of 41 XFS/XFG patients who met inclusion criteria was included in this prospective, observer-masked, crossover, comparison protocol. All subjects underwent a 24-h untreated curve and were then randomised to either evening administered BTFC or latanoprost for 3 months and then switched to the opposite therapy. At the end of each treatment period, patients underwent a treated 24-h IOP assessment.. 37 patients completed the trial. At baseline, mean untreated 24-h IOP was 31.1 mm Hg. Mean 24-h IOP with BTFC was significantly lower than with latanoprost (18.9 vs 21.2 mm Hg; p<0.001). Furthermore, BTFC reduced IOP significantly more than latanoprost at every time point, for the mean peak and trough 24-h IOP (p<0.001). There was no difference, however, in mean 24-h IOP fluctuation between the two medications (3.8 with BTFC vs 4.2 with latanoprost; p=0.161). Both treatments were well tolerated and there was no statistically significant difference for any adverse event between them.. As first choice therapy in high-pressure, at-risk exfoliation patients, BTFC controlled mean 24-h IOP significantly better than latanoprost monotherapy.

Topics: Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Circadian Rhythm; Cloprostenol; Cross-Over Studies; Double-Blind Method; Drug Combinations; Exfoliation Syndrome; Female; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Prostaglandins F, Synthetic; Timolol; Tonometry, Ocular; Treatment Outcome; Visual Field Tests; Visual Fields

To evaluate efficacy and safety of bimatoprost 0.03% preservative-free (PF) ophthalmic solution versus bimatoprost 0.03% (Lumigan) ophthalmic solution for glaucoma or ocular hypertension.. In this double-masked, parallel-group study, patients were randomised to bimatoprost PF or bimatoprost for 12 weeks. The primary analysis for non-inferiority was change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12. For equivalence, it was average eye IOP in the intent-to-treat population at each time point at weeks 2, 6 and 12.. 597 patients were randomised (bimatoprost PF, n=302 and bimatoprost, n=295). The 95% CI upper limit for worse eye IOP change from baseline was <1.5 mm Hg at each week 12 time point, meeting prespecified non-inferiority criteria. The 95% CI upper limit for the treatment difference for average IOP was 0.69 mm Hg and the lower limit was -0.50 mm Hg at all follow-up time points (hours 0, 2 and 8 at weeks 2, 6 and 12), meeting equivalence criteria. Both treatments showed decreases in mean average eye IOP at all follow-up time points (p<0.001), were safe and well tolerated.. Bimatoprost PF is non-inferior and equivalent to bimatoprost in its ability to reduce IOP-lowering with a safety profile similar to bimatoprost.

Topics: Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Double-Blind Method; Female; Glaucoma; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Preservatives, Pharmaceutical; Prospective Studies; Therapeutic Equivalency; Tonometry, Ocular; Visual Acuity

To determine if adherence and convenience of once-daily glaucoma medication is greater in the morning or the evening.. Prospective, randomized crossover treatment trial.. Thirty patients newly diagnosed with glaucoma or ocular hypertension requiring intraocular pressure (IOP) reduction were started on travoprost eye drops and randomized to either morning or evening administration for 1 month. They were then crossed over to the opposite dosing schedule for the following month. Adherence was monitored using an automated dosing aid.. Adherence was compared between morning versus evening dosing and first versus second month dosing. Demographic characteristics were obtained, treatment effect was measured, and patients completed a post-study questionnaire regarding the convenience of the 2 dosing regimens.. Patient adherence overall was good (89.3%). There was no statistically significant difference (P=0.07) in adherence between morning dosing (90.9%) and evening dosing (87.3%). Adherence in the first month (91.7%) was superior to the second month (86.5%). There was no significant difference in IOP response between morning and evening dosing. Patients found morning dosing more convenient than evening dosing.. Early adherence to treatment with a prostaglandin analogue is good, but patients prefer morning administration to evening administration. This may lead to greater adherence with morning administration, particularly among men. Adherence decreases from the first to second month after initiation of treatment. IOP response to this treatment is not significantly affected by morning versus evening administration.

Topics: Administration, Topical; Aged; Aged, 80 and over; Antihypertensive Agents; Cloprostenol; Cross-Over Studies; Drug Chronotherapy; Female; Glaucoma; Humans; Intraocular Pressure; Male; Medication Adherence; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prospective Studies; Surveys and Questionnaires; Travoprost

To determine if eyelid closure (ELC) after topical prostaglandin instillation provides greater intraocular pressure (IOP) reduction than prostaglandin instillation without ELC.. Patients receiving chronic bilateral prostaglandin monotherapy were enrolled in this study. The study intervention, ELC, was randomly assigned to one eye, while the fellow eye served as control. ELC was performed for either 1 min or 3 min. After a 1-day washout, the IOP was measured in a masked fashion at baseline, 1 h and 24 h, and at a final visit that took place 7-14 days after enrolment. All visits were scheduled during the morning, and every individual patient's visits occurred at similar times during the day. The main outcome was difference between intervention eye and control eye in IOP-lowering from baseline.. 51 patients meeting eligibility criteria were enrolled: 25 were randomised to ELC for 1 min and 26 to ELC for 3 min in the intervention eye. The pooled IOP-lowering difference (95% CI, p value) in intervention versus control eyes was 0.24 mm Hg (-0.5 to 0.9, p=0.50), 0.24 mm Hg (-0.7 to 1.2, p=0.61) and 0.24 mm Hg (-0.7 to 1.2, p=0.61) in the overall group, 1 min ELC subgroup and 3 min ELC subgroup, respectively. The effect of ELC did not change significantly across visits.. ELC did not provide significant additional IOP reduction compared with no ELC in patients using chronic prostaglandin monotherapy. Trial Registration http://clinicaltrials.gov/ct2/show/NCT0083283.

Topics: Absorption; Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Eyelids; Female; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Male; Prostaglandins F, Synthetic; Time Factors; Tonometry, Ocular; Travoprost

To evaluate the changes in intraocular pressure (IOP) and pupil size in 12 Beagles with inherited glaucoma after instillations of 0.033, 0.0033, 0.001, 0.00033, and 0.0001% travoprost (Travatan®-Alcon Laboratories, Inc., Ft Worth, TX, USA) in multiple single-dose studies.. Intraocular pressure and pupil diameter (PD) measurements were obtained at 9 am, 12 pm, 3 pm, and 9 am the following day (24 h) in two groups of six glaucoma dogs. After 7 days, the vehicle or concentration was repeated in the contralateral eye of the same animals.. Concentrations of 0.00033, 0.001, and 0.0033% travoprost significantly lowered IOP and PD, but the 0.0001% concentration provided limited IOP changes, although PD changes were still significant. This suggests travoprost is effective in the dog to lower IOP and reduce pupil size at concentrations starting between 0.0001 and 0.00033%.. The dose response for travoprost in the glaucomatous Beagle indicates this model is highly sensitive to this group of drugs, even at concentrations as low as 0.00033% (1/12 the commercially available concentration).

Topics: Animals; Cloprostenol; Cross-Over Studies; Dog Diseases; Dogs; Dose-Response Relationship, Drug; Female; Glaucoma; Male; Travoprost

To study compliance in the medical treatment of glaucoma, its possible association with other factors, and quality of life of patients with glaucoma.. Longitudinal prospective study of 60 patients with ocular hypertension or glaucoma who were treated with travoprost, or with a fixed combination of travoprost/timolol nightly. All subjects were given a Travalert(®) dosing aid and were reviewed after one and four months. Strict and relative compliance data were collected on each visit. The relationship between compliance and other variables was studied using univariate analysis. To analyse quality of life, patients were given self-assessment STAI anxiety questionnaires after the first and last visits.. Relative compliance for the four months was significantly greater than the strict compliance (P=.001). In the group of least compliance the number of patients on treatment with combination therapy was significantly higher than those on monotherapy. In the lost cases, the number of men was significantly higher than women. No association was found in the other variables. The anxiety was similar to that in the normal population.. Compliance is very important in the treatment of glaucoma, and our study provides objective data through the use of Travalert dosing aid with relative compliances of 70%. Patients with combined therapies have lower compliance than those on monotherapy.

Topics: Administration, Ophthalmic; Aged; Anxiety; Cloprostenol; Drug Administration Schedule; Drug Combinations; Female; Follow-Up Studies; Glaucoma; Humans; Instillation, Drug; Male; Medication Adherence; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prospective Studies; Quality of Life; Reminder Systems; Surveys and Questionnaires; Timolol; Travoprost

Topics: Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Double-Blind Method; Drug Combinations; Drug Therapy, Combination; Female; Glaucoma; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Timolol; Tonometry, Ocular; Treatment Outcome

To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of ophthalmic formulations of bimatoprost 0.01% and 0.0125% compared with bimatoprost 0.03%.. Prospective, randomized, double-masked, multicenter clinical trial.. Patients with glaucoma or ocular hypertension were randomized to receive once-daily bimatoprost 0.01% (n = 186), bimatoprost 0.0125% (n = 188), or bimatoprost 0.03% (n = 187) for 12 months. The primary efficacy measure was IOP. Safety measures included adverse events and an objective assessment of conjunctival hyperemia.. Baseline mean IOPs were similar among treatment groups. Differences in mean IOP between the bimatoprost 0.01% or 0.0125% groups and the bimatoprost 0.03% group were less than 0.9 mm Hg throughout follow-up. Bimatoprost 0.01%, but not bimatoprost 0.0125%, was equivalent in efficacy to bimatoprost 0.03% based on predetermined criteria (limits of the 95% confidence interval of the between-group difference in mean IOP within +/- 1.5 mm Hg at all time points and within +/- 1 mm Hg at most time points). The overall incidence of treatment-related adverse events was reduced significantly in the bimatoprost 0.01% and bimatoprost 0.0125% groups compared with the bimatoprost 0.03% group (P < or = .034). The percentage of patients with a moderate to severe increase from the baseline macroscopic hyperemia score was: bimatoprost 0.01%, 3.2%; bimatoprost 0.0125%, 9.0%; bimatoprost 0.03%, 9.1% (P = .019 for bimatoprost 0.01% vs 0.03%).. Bimatoprost 0.01% was equivalent to bimatoprost 0.03% in lowering IOP throughout 12 months of treatment and demonstrated improved tolerability, including less frequent and severe conjunctival hyperemia. Bimatoprost 0.01% demonstrated a better benefit-to-risk ratio than bimatoprost 0.0125%.

Topics: Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Double-Blind Method; Female; Glaucoma; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Patient Satisfaction; Prospective Studies; Surveys and Questionnaires; Tonometry, Ocular; Young Adult

To evaluate 24-h efficacy of travoprost/timolol fixed combination (TTFC) vslatanoprost/timolol fixed combination (LTFC) in exfoliative glaucoma (XFG).. A prospective, single-masked, crossover, active-controlled, randomized 24-h comparison.. After up to a 6-week medicine-free period, XFG patients were randomized to either TTFC or LTFC for 3 months, dosed each evening, and then changed to the opposite treatment for another 3 months. At the end of the washout, and both treatment periods, a 24-h intraocular pressure (IOP) curve was measured.. In total, 40 patients completed the study. The TTFC group showed a lower mean absolute 24-h IOP (18.7±2.6 vs 19.6±2.6 mm Hg, P<0.001), maximum IOP (20.5±2.6 vs 21.5±2.6 mm Hg, P<0.001) and 24-h IOP range (3.4±1.3 vs 4.1±1.6 mm Hg, P=0.01). At individual time points, TTFC showed reduced IOPs compared with LTFC, after a Bonferroni correction, at 1000, 1800, and 2200 hours (P≤0.04). No statistical differences existed at hours: 0600, 1400, and 0200 (P≥0.05) and for the minimum IOP (P=0.09).. This study suggests that evening-dosed TTFC may provide greater 24-h IOP reduction, primarily at the 1800 hours time point, compared with LTFC in XFG.

Topics: Aged; Antihypertensive Agents; Cloprostenol; Cross-Over Studies; Drug Administration Schedule; Drug Therapy, Combination; Exfoliation Syndrome; Female; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Prospective Studies; Prostaglandins F, Synthetic; Single-Blind Method; Time Factors; Timolol; Travoprost

The aim of this study was to compare the efficacy of bimatoprost 0.03% with brimonidine 0.2% in preventing intraocular pressure (IOP) elevations after neodymium:yttrium–aluminum–garnet (Nd:YAG) laser posterior capsulotomy.. In this prospective, randomized, double-masked study, 195 eyes of 195 consecutive patients who had YAG laser capsulotomy for posterior capsule opacification were recruited. Eyes received either 1 drop of bimatoprost 0.03% (98 patients) or brimonidine 0.2% (97 patients) at 1h before laser surgery. A masked observer measured IOP by Goldmann applanation tonometry before treatment and after treatment at 1h, 3h, 24h, and 7 days. Inflammation was evaluated after surgery. Formation of cystoid macular edema was assessed by measuring the macular thickness before and after laser surgery.. The average peak of postoperative IOP elevation was 2.2±3.9mm Hg in the bimatoprost 0.03% and 3.6±3.1mm Hg in the brimonidine 0.2% group. The difference was statistically significant (P<0.001). Postoperative IOP elevations of 10mm Hg or more occurred in 1 eye (1.56%) in the bimatoprost 0.03% group and 5 eyes (7.35%) in the brimonidine 0.2%. This difference was statistically significant (P<0.001). Macular edema and anterior chamber reaction were not observed related to bimatoprost. No clinically significant side effects were noted in either group.. Our results indicate that prophylactic use of bimatoprost 0.03% is more effective than brimonidine 0.2% in preventing IOP elevation immediately after YAG laser capsulotomy. Bimatoprost 0.03% as a prostamide analog may provide new option for preventing IOP elevation after YAG laser capsulotomy.

Topics: Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Brimonidine Tartrate; Capsule Opacification; Cataract; Cloprostenol; Female; Glaucoma; Humans; Intraocular Pressure; Laser Therapy; Lasers, Solid-State; Male; Middle Aged; Neodymium; Ocular Hypertension; Ophthalmic Solutions; Posterior Capsule of the Lens; Quinoxalines; Tonometry, Ocular

To investigate the impact of an intervention program to improve adherence with topical, once daily therapy for glaucoma.. Randomized controlled clinical trial.. Sixty-six patients with glaucoma being treated with a prostaglandin analog in 1 or both eyes at the Scheie Eye Institute or Wilmer Eye Institute between November 2006 and June 2007.. In an observational study, participants who took 75% or fewer doses (as measured using the travoprost Dosing Aid [DA]) during an initial 3-month period were randomized into 2 groups. The intervention group watched an educational video, reviewed current barriers to drop-taking and possible solutions with a study coordinator, received regular phone call reminders, and had audible and visible reminders activated on their DA devices. The control group was told to take drops as prescribed and received no additional intervention.. Change in drop use adherence as determined by the DA device.. In the 3-month observation period before randomization, intervention group patients had used a mean of 54+/-17% of scheduled doses, and this increased to 73+/-22% during the following 3-month period (P<0.001, n = 35). The control mean adherence rate of 46+/-23% at baseline was statistically unchanged during the follow-up observation period (51+/-30%, P = 0.16, n = 31). In a multivariate analysis, intervention, baseline compliance rate of <50%, and white ethnicity were predictors of improved adherence during the 3 months of intervention. The intraocular pressure (IOP) of the intervention and control groups did not change between months 3 and 6 after intervention (P = 0.96, 0.34, respectively), and there was no correlation of IOP change with adherence rate change between both groups (Pearson correlation r = 0.06, P = 0.51).. A multifaceted intervention significantly increased adherence with glaucoma medications. Those with improved adherence were in the intervention group, had very low adherence rates at baseline, and were white. IOP did not correlate with adherence. Further research is needed to determine which components of this intervention were most effective.

Topics: Aged; Aged, 80 and over; Antihypertensive Agents; Cloprostenol; Drug Monitoring; Female; Follow-Up Studies; Glaucoma; Humans; Intraocular Pressure; Male; Medication Adherence; Middle Aged; Ophthalmic Solutions; Patient Compliance; Patient Education as Topic; Prospective Studies; Travoprost; Video Recording

To determine the medium-term effect of travoprost on the daytime intraocular pressure (IOP) of patients with normal tension glaucoma (NTG) METHODS: Newly diagnosed NTG patients underwent baseline, daytime, hourly IOP phasing. Patients were randomised to either treatment or no treatment (control). Treatment comprised once daily topical travoprost 0.004%. After 6 months, the participants underwent their second IOP phasing.. Data from 88 participants were analysed-54 were randomised to treatment and 34 to the control group. The mean duration of treatment was 6 months. The average, maximum and minimum diurnal IOPs for treated patients were statistically significantly lower than for control patients at follow-up (p<0.001). When compared with baseline IOP, the travoprost treated group demonstrated a decrease of 16.1%, 13.5% and 16.7% in the average IOP, maximum IOP, and minimum IOP respectively. Of those treated, about one-third achieved a decrease in average IOP of at least 20%; only about one-tenth achieved a reduction of at least 30%.. Travoprost monotherapy had a sustained hypotensive effect in NTG and achieved a reasonable or good response (>20% reduction in average IOP) in 32.9% of treated eyes. However, in the majority of eyes with NTG, travoprost monotherapy appeared unable to produce the desirable 30% reduction in average IOP.

Topics: Aged; Antihypertensive Agents; Circadian Rhythm; Cloprostenol; Female; Follow-Up Studies; Glaucoma; Humans; Intraocular Pressure; Male; Middle Aged; Single-Blind Method; Travoprost; Treatment Outcome

The stability of ophthalmic preparations in multidose containers is influenced by the preservative as well as the stability of the active ingredient. Unstable drugs may require refrigeration to preserve their active ingredient level and they are more likely to degrade over time, therefore becoming more susceptible to degradation based on patient mishandling. The purpose of this study was to determine the degree of molecular degradation that occurs in bimatoprost and latanoprost in a patient-use setting.. This was an open-label, laboratory evaluation of the relative stability of bimatoprost and latanoprost. Patients presently using bimatoprost (n = 31) or latanoprost (n = 34) were identified at 2 clinical sites in Brazil. Patients were instructed to use and store their drops as usual and return all used medication bottles between day 28 and day 34 after opening.. Bimatoprost demonstrated no degradation, but latanoprost degraded at various levels. The mean age of bimatoprost was 43.0 +/- 3.4 days and the mean age of latanoprost was 43.9 +/- 2.8 days (P = .072). The mean percentage of labeled concentration was 103.7% in the bimatoprost bottles and 88.1% in the latanoprost bottles (P < 001).. This study showed that bimatoprost maintained > or =100% concentration throughout the study period while latanoprost did not.

Topics: Adult; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Packaging; Drug Stability; Follow-Up Studies; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Ophthalmic Solutions; Prostaglandins F, Synthetic; Retrospective Studies; Seasons; Temperature; Time Factors

To evaluate 24 h intraocular pressure (IOP) and blood pressure (BP) with bimatoprost or latanoprost in patients with normal-tension glaucoma.. Prospective, randomised, crossover, active-controlled, observer-masked study.. After a 6-week medicine-free period, we randomised patients to either latanoprost or bimatoprost for 8 weeks and then to the opposite medicine for 8 weeks. At baseline, and at the end of each treatment period, we evaluated IOP and BP at 08:00 and then every 2 h over the 24 h day. Diastolic ocular perfusion pressure (DOPP) was calculated from the above parameters.. Forty completed patients had a 24 h untreated baseline IOP of 15.5 (2.3) mm Hg, and a DOPP of 59.2 (6.1) mm Hg. Both treatments lowered IOP at each time point (p<0.006), and over the 24 h curve (p<0.001, both medicines 13.1 mm Hg, 16% decrease). No difference existed between treatments in absolute IOP, at each time point, and over the 24 h curve (p>or=0.26). Additionally, no differences were found between treated 24 h systolic (p>or=0.29) and diastolic BP (p>or=0.12). The mean 24 h DOPP for latanoprost was increased from baseline (3%, p = 0.031) but not for bimatoprost (2%, p = 0.21). However, no difference in DOPP existed between treatments at any time point or over the 24 h curve (p>or=0.17). No difference was observed between treatments for any adverse event (p>0.05).. In patients with normal-tension glaucoma, both bimatoprost and latanoprost reduce the 24 h intraocular pressure from untreated baseline to a similar extent. Latanoprost is associated with slightly improved ocular diastolic perfusion pressure over 24 h but similar absolute perfusion levels to that of bimatoprost.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Blood Pressure; Blood Pressure Monitoring, Ambulatory; Cloprostenol; Epidemiologic Methods; Female; Glaucoma; Hemodynamics; Humans; Intraocular Pressure; Italy; Latanoprost; Male; Middle Aged; Prostaglandins F, Synthetic; Time Factors; Treatment Outcome

Bimatoprost 0.03% has been shown to consistently reduce mean intraocular pressure (IOP) more than timolol 0.5% over 2 years. To further evaluate long-term safety and efficacy, once-daily bimatoprost 0.03% was compared with timolol 0.5% twice daily through year 4.. In this multicentre, double-masked, randomised, controlled trial, glaucoma and ocular hypertension patients (n = 152) who completed phase III bimatoprost trials through month 36 were enrolled in a study extension through month 48. Patients randomised to bimatoprost once daily (n = 78) or timolol twice daily (n = 35) continued on the same regimen for a fourth year. Patients randomised to bimatoprost twice daily had been switched to bimatoprost once daily dosing at month 24 (bimatoprost twice daily/once daily treatment group), and continued with once daily dosing through month 48 (n = 39). IOP was measured at 08:00 and 10:00 at months 39, 42, 45 and 48. Safety measures included adverse events, biomicroscopy, ophthalmoscopy, visual acuity and visual field.. Baseline IOP was comparable among groups. During year 4, mean IOP reductions from baseline were 7.0 to 8.1 mm Hg with bimatoprost once daily and 6.5 to 7.9 mm Hg with bimatoprost twice daily/once daily, significantly greater than with timolol twice daily (3.8 to 5.8 mm Hg, p< or =0.035) at all measurements. Over 4 years, the mean IOP reduction from baseline at 08:00 and 10:00 was 1.9 to 3.9 mm Hg (35% to 100%) greater with bimatoprost once daily than with timolol (p< or =0.013). Low IOPs were achieved by more bimatoprost than timolol patients (p< or =0.042). No safety concerns developed during long-term bimatoprost treatment; two patients in the timolol treatment group discontinued after month 36 because of adverse events. The most common treatment-related adverse event in the bimatoprost treatment groups was conjunctival hyperaemia.. Bimatoprost once daily provided sustained IOP lowering greater than timolol twice daily and was well tolerated over long-term use.

Topics: Amides; Analysis of Variance; Bimatoprost; Cloprostenol; Conjunctival Diseases; Double-Blind Method; Drug Administration Schedule; Female; Glaucoma; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Timolol; Treatment Outcome; Visual Acuity

This study compares intraocular pressure (IOP)-lowering efficacy and retrobulbar hemodynamic effects of bimatoprost and travoprost in patients with newly diagnosed open-angle glaucoma.. Patients were randomly assigned to one of two treatment groups (bimatoprost group, n = 36; travoprost group, n = 46). IOP levels were measured with Goldmann applanation tonometer. Peak systolic velocity, end-diastolic velocity and resistivity index were obtained for each vessel by color Doppler imaging.. Both bimatoprost and travoprost significantly lowered IOP on days 30, 90 and 180 (p < 0.001). There was no significance between the 2 drugs on all follow-up visits. End-diastolic velocity of central retinal artery on day 180 was significantly higher than the value obtained at baseline in both groups.. Patients were likely to achieve and maintain low target IOP with both drugs. Both drugs also resulted in improvement in the central retinal artery blood flow.

Topics: Adult; Aged; Aged, 80 and over; Amides; Bimatoprost; Blood Flow Velocity; Cloprostenol; Diastole; Eye; Female; Follow-Up Studies; Glaucoma; Hemodynamics; Humans; Intraocular Pressure; Lipids; Male; Middle Aged; Regional Blood Flow; Retinal Artery; Time Factors; Travoprost; Ultrasonography, Doppler, Color

The aim of this study was to evaluate the incidence of hyperaemia in patients using bimatoprost and to determine if simple interventions result in increased understanding of glaucoma and hyperaemia.. This was a multicentre, open-label, evaluator-masked clinical trial of 106 patients. Prior to enrolling in the trial, patients were washed out from any ocular hypotensive medications and prescribed bimatoprost daily in the evening for 6 weeks. Patients were randomised to one of two groups: intervention and no intervention. Patients in the intervention group (n=63) were given a fact sheet explaining the importance of reducing intraocular pressure (IOP) and the efficacy of bimatoprost, while patients in the no intervention group (n=43) were instructed only to instil bimatoprost daily and were given no additional instructions.. As graded by the masked investigators, conjunctival hyperaemia peaked 1 day after commencing bimatoprost, with a mean of 1.2 (0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe). By day 7, hyperaemia levels were approximately trace (0.79) and continued to decrease throughout the study. There were no significant differences between groups in mean conjunctival hyperaemia at any study visit (P> or =0.215). At every visit, patients in the intervention group were significantly more likely than patients in the no intervention group to report that lowering IOP was very important for preserving vision (P< or =0.001). At week 6, 98% of patients in the intervention group reported that IOP-lowering was very important for preserving vision, compared with 76% of patients who did not receive the intervention (P< or =0.001). Patients in the intervention group were more likely than patients in the no intervention group to be willing to continue to use bimatoprost, despite hyperaemia. This difference was statistically significant at day 1 (P=0.003).. Patients were not bothered by the trace.mild hyperaemia associated with bimatoprost therapy. Patient education can improve patient acceptance of a prescribed regimen and potentially increase compliance.

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Female; Glaucoma; Humans; Hyperemia; Intraocular Pressure; Male; Ocular Hypertension; Patient Compliance; Patient Education as Topic

To investigate if combined intraocular pressure (IOP)-lowering medication with travoprost/timolol fixed combination and a carbonic anhydrase inhibitor, brinzolamide, is superior to both travoprost monotherapy and travoprost/timolol fixed-combination therapy in primary open-angle glaucoma and ocular hypertension.. Following a 4-week wash-out period and using 4-week long treatment periods, 20 primary open-angle glaucoma or ocular hypertension patients were treated with evening travoprost 0.004%, then switched to evening travoprost 0.004%/timolol 0.5% fixed combination, and finally the treatment was combined with adjunctive twice-daily brinzolamide 1% ophthalmic suspension. Both eyes were treated, but only one eye per patient (the eye with the higher mean diurnal IOP at baseline), was evaluated. IOP was measured at 8 a.m., 12 noon and 4 p.m. at baseline and at the end of each treatment period.. Mean diurnal IOP (mean (SD)) at baseline was 28.5 (7.3) mmHg which decreased to 22.3 (6.3) mmHg on travoprost, 19.2 (3.4) mmHg on travoprost/timolol fixed combination and 17.3 (3.4) mmHg when the brinzolamide was added to the travoprost/timolol combination (ANOVA, contrast test, p<0.003 for all comparisons). The individual time point IOP values showed similar and significant stepwise differences.. Adjunctive brinzolamide medication provided further IOP decrease in patients receiving evening-dosed travoprost/timolol fixed combination. The travoprost/timolol fixed combination was significantly more effective in IOP reduction than travoprost monotherapy, which by itself induced a significant IOP decrease compared to the untreated baseline value. The results of this open label study suggest that combined therapy with travoprost/timolol fixed combination and brinzolamide is clinically useful for IOP-lowering in primary open-angle glaucoma and ocular hypertension.

Topics: Aged; Cloprostenol; Drug Combinations; Drug Therapy, Combination; Female; Glaucoma; Humans; Intraocular Pressure; Male; Middle Aged; Sulfonamides; Thiazines; Timolol; Travoprost

To evaluate the diurnal intraocular pressure (IOP) control and safety of bimatoprost versus latanoprost in exfoliative glaucoma (XFG).. One eye of 129 consecutive patients with XFG (mean (SD) age 66.5 (8.3) years) was included in this prospective, observer-masked, three-centre, crossover comparison. After a 4-6 week medicine-free period patients were randomised to bimatoprost or latanoprost monotherapy for 3 months. Patients were then switched to the opposite treatment for another 3 months. At the end of the washout and the treatment periods diurnal IOP was measured at 0800, 1300, and 1800.. At baseline the IOP (mean (SD)) was 28.0 (4.0), 26.9 (3.6), and 25.9 (3.6) mm Hg, at the three time points, respectively. Both treatments significantly reduced mean diurnal IOP at month 3. Mean diurnal IOP was 26.9 (3.5) mm Hg at baseline, 17.6 (3.3) mm Hg with bimatoprost, and 18.6 (3.6) mm Hg with latanoprost (p<0.0001). Furthermore, lower IOP values were obtained with bimatoprost at all time points (17.9 (3.4), 17.3 (3.3), and 17.6 (3.5) mm Hg, respectively) compared with latanoprost (18.7 (3.6), 18.5 (3.6), and 18.6 (4.1) mm Hg, respectively). The corresponding mean differences (0.8, 1.1, and 1.0 mm Hg, respectively) were all significant (p<0.001 for each comparison). Significantly more patients with XFG obtained a target diurnal IOP <17 mm Hg with bimatoprost than with latanoprost, 55/123 (45%) v 34/123 (28%); (p = 0.001), and significantly fewer patients were non-responders with bimatoprost than with latanoprost (5 v 13, p = 0.021). More patients reported at least one adverse event with bimatoprost than with latanoprost (58 v 41 at 3 months; p = 0.0003).. This crossover study suggests that better diurnal IOP control is obtained with bimatoprost than with latanoprost in patients with XFG.

Topics: Adult; Aged; Amides; Antihypertensive Agents; Bimatoprost; Circadian Rhythm; Cloprostenol; Cross-Over Studies; Exfoliation Syndrome; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Lipids; Middle Aged; Prostaglandins F, Synthetic; Single-Blind Method

Intraocular pressure (IOP) fluctuation over 24 hours is an independent risk factor for glaucoma progression. Nighttime lOP measurement is not routine practice.. The aim of this study was to predict, using a Bayesian network (BN), the likelihood of a nighttime IOP peak >18 mm Hg based on daytime measurements.. A pooled analysis was conducted using a BN. Data from 3 clinical trials of adult patients with glaucoma or ocular hypertension were used. IOP values at 0800, 1200, 1600, and 2000 hours were dichotomized according to the 18-mm Hg threshold. Patients' lOPs were assessed from the pretreatment washout periods and during latanoprost or travoprost treatments. A BN was constructed to study associations between daytime and nighttime IOP values, and prostaglandin analogue IOP control adjusted for trial. The nighttime IOP peak was defined as the maximum IOP value between 2400 and 0400 hours.. The study identified 382 daily IOP vectors (6 measures per day, every 4 hours for 24 hours; pretreatment, 208; latanoprost, 73; travoprost, 101). Based on the BN, IOP at 0800 hours was associated with IOP at 1200 hours, which was also associated with the IOP at 1600 hours. IOP at 2000 hours was predicted by the IOPs at 1200 and 1600 hours. The nighttime IOP peak was associated with IOP >18 mm Hg at 1200 and 2000 hours. The percentage of patients with controlled IOP at 1200 and 2000 hours was higher in those receiving travoprost than in those receiving latanoprost. Travoprost was also associated with an increased probability of controlling nighttime IOP values >18 mm Hg (travoprost, 76.9%-77.5% vs latanoprost, 66.7%-67.9%). Daily IOP fluctuations were not found to be associated with nighttime IOP peak.. Daytime IOP measurements are highly intercorrelated. According to this BN, IOP at 1200 and 2000 hours are more strongly associated with the nighttime IOP peak than other IOP measurements. BN can estimate the risk of a nighttime IOP peak >18 mm Hg. Daytime IOP control was important for nighttime IOP control. These findings require validation in a clinical setting.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Bayes Theorem; Circadian Rhythm; Cloprostenol; Female; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Models, Biological; Ocular Hypertension; Prostaglandins F, Synthetic; Reproducibility of Results; Travoprost; Treatment Outcome

The aim of this study was to compare the tolerability and efficacy of once-daily travoprost 0.004% versus latanoprost 0.005% for 6 weeks followed by 6 weeks of once-daily travoprost 0.004% in decreasing intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OH).. This multicenter, randomized, doublemasked, active-controlled, parallel-group trial was conducted at 32 centers across Latin America. Patients aged > or =18 years with OAG or OH were randomly assigned to receive topical travoprost 0.004% or latanoprost 0.005% 1 drop QD (9 PM) for 6 weeks (masked phase). At 6 weeks, all patients were assigned to receive open-label travoprost 0.004% 1 drop QD (9 PM) for 6 additional weeks (open-label phase). Study visits were scheduled at weeks 1, 2, 4, 6, 8, and 12. At each study visit, IOP was measured at 5 PM (+/-1 hour; approximately 20 hours after study drug administration). IOP changes from baseline were combined (pooled) from the 1-, 2-, 4-, and 6-week data to provide a comparison between the 2 treatment groups. Ocular adverse events (AEs) were monitored using slit-lamp examination.. A total of 302 patients were enrolled (travoprost group, 155 patients; latanoprost group, 147 patients). The mean (SD) age of the travoprost group was 61.9 (10.6) years; 60.6% were female; and 47.1% were white. The mean (SD) age of the latanoprost group was 60.5 (12.4) years; 62.6% were female; and 49.0% were white. Mean IOP values were not significantly different between the travoprost and latanoprost groups at baseline (24.7 vs 24.2 mm Hg) or 6 weeks; however, the between-group difference in reductions from baseline in pooled IOP during the masked phase of the study was statistically significant (-8.3 vs -7.5 mm Hg; P = 0.009). At weeks 6 and 12, mean lOP levels were 16.1 and 16.2 mm Hg, respectively, in the travoprost group and 16.4 and 16.1 mm Hg in the group that was switched from latanoprost to travoprost (all, P = NS). The most common ocular AEs that occurred with masked travoprost, latanoprost, and open-label travoprost were hyperemia (26.9%, 12.2%, and 5.3%, respectively), discomfort (3.2%, 3.4%, and 1.1%), and pruritus (4.5%, 2.0%, and 2.1%).. In this population of patients with OAG or OH, 6-week treatment with travoprost 0.004% was associated with a significantly greater decrease from baseline in pooled IOP compared with latanoprost 0.005% 20 hours after administration. There were no significant differences between the 2 groups. Travoprost and latanoprost were well tolerated.

Topics: Administration, Topical; Analysis of Variance; Antihypertensive Agents; Cloprostenol; Double-Blind Method; Drug Administration Schedule; Female; Glaucoma; Glaucoma, Open-Angle; Gonioscopy; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ophthalmic Solutions; Prostaglandins F, Synthetic; Tonometry, Ocular; Travoprost; Treatment Outcome; Visual Acuity

This study contrasts the utilization of adjunctive medication associated with travoprost, bimatoprost, or latanoprost, as primary glaucoma therapies.. Patients in the Medco Health database who initiated prostaglandin analog therapy on travoprost, bimatoprost or latanoprost between January 1, 2002 and July 31, 2002 were selected if they had no prostaglandin analog use in the prior 6 months. Patients were also required to have 12 months of prostaglandin therapy subsequent to the initial prescription. Data were available through July 31, 2003. The t-test and chi-square were used where appropriate to calculate p-values and assess significant differences.. A total of 13 171 benefit-eligible subjects were identified of which 8381 (64%), 2637 (20%), and 2153 (16%) patients were treated with latanoprost, bimatoprost, and travoprost, respectively. There were no significant differences in mean age or gender between the three study groups with the exception that latanoprost patients were statistically older than travoprost patients (69.0 vs. 68.0). This was not considered a clinically meaningful difference. Overall, patients using travoprost or bimatoprost had a significantly lower rate of adjunctive medication use compared to patients starting on latanoprost monotherapy (22.5%, 23.2%, and 30.2 %, respectively). Therefore, for every 14 patients treated with latanoprost instead of travoprost or bimatoprost, one additional patient would be expected to need adjunctive therapy with another agent. The difference between travoprost and bimatoprost patients was not significant.. The use of adjunctive medications to control intraocular pressure was significantly higher for latanoprost patients compared to travoprost and bimatoprost patients. This finding should be interpreted in the context that this study was based only on prescription claims data. It is important to simplify ophthalmic medical regimen as it is more cost effective, better for the patient, and minimizes the washout effect from administering two eye medications within 5 min. Decreasing the complexity of the patients' drug regimen may lead to increased adherence to prescribed therapy and a decreased risk of the incidence of blindness.

Topics: Aged; Amides; Bimatoprost; Cloprostenol; Drug Therapy, Combination; Female; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Lipids; Male; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Travoprost

The objective of this study was to assess the hypotensive efficacy of timolol maleate 0.5%, brinzolamide 1%, or brimonidine tartrate 0.2% ophthalmic solution, administered in conjunction with travoprost 0.004%, in patients with primary open-angle laucoma (OAG) or ocular hypertension (OHT) whose intraocular pressure (IOP) did not meet the treatment target using travoprost 0.004% monotherapy.. This was a randomized, comparative, investigator-masked study. Patients with OAG or OHT treated with travoprost 0.004% monotherapy were randomized to receive 1 of the 3 adjunctive therapies (timolol maleate 0.5%, brinzolamide 1%, or brimonidine tartrate 0.2%), 1 drop BID in each randomized eye, in addition to 1 drop QD of travoprost for a period of 4 weeks. IOP was measured on days 0 (travoprost 0.004%) and 28 (travoprost 0.004% and adjunctive treatment). Adverse events were monitored on days 0 and 28 by patient interview.. Twenty-nine patients with OAG (46 eyes) and 3 patients with OHT (6 eyes), with a total of 52 eligible eyes, completed the study; 28 eyes were from male patients and 24 were from female patients. In addition to continuing travoprost treatment, 20 eyes received timolol, 16 eyes received brinzolamide, and 16 eyes were treated with brimonidine. There were no significant differences among the groups in the mean (SD) IOP at baseline on day 0 (19.0 [4.1], 17.2 [3.5], and 17.0 [3.1] mm Hg, respectively; P=NS). On day 28, the reduction in mean (SD) IOP in eyes treated with brimonidine tartrate 0.2% was significantly smaller (2.3 [1.8] mm Hg vs 3.9 [1.8] mm Hg [P=0.01]) and the mean (SD) percentage reduction in IOP was significantly smaller (13.4% [9.1%] vs 20.2% [7.5%] [P=0.01]) when compared with timolol maleate 0.5%, and likewise when compared with brinzolamide 1% (4.0 [2.1] mm Hg [P=0.02] and 22.7% [8.6%] [P=0.006], respectively). The group treated with brinzolamide was associated with a similar reduction in IOP to timolol (P=NS for both mean [SD] IOP and percentage reduction in IOP compared with timolol monotherapy). Barring the occasional conjunctival hyperemia, which was excluded as an adverse event for the purposes of this study, no adverse events were recorded.. Brinzolamide 1% and timolol maleate 0.5% treatment were both associated with a significantly greater reduction in IOP compared with brimonidine 0.2% when administered as a nonfixed adjuvant to travoprost 0.004% in the treatment of patients with OAG and OHT whose IOP was inadequately controlled with travoprost monotherapy. All treatments were well tolerated.

Topics: Adrenergic alpha-Agonists; Adrenergic beta-Antagonists; Aged; Brimonidine Tartrate; Carbonic Anhydrase Inhibitors; Cloprostenol; Double-Blind Method; Drug Therapy, Combination; Female; Glaucoma; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Quinoxalines; Sulfonamides; Thiazines; Timolol; Travoprost

The primary objective of this study was to determine the intraocular pressure- (IOP) lowering efficacy over two consecutive 24-h periods of travoprost 0.004% ophthalmic solution (Travatan) compared to latanoprost 0.005% (Xalatan) dosed once daily in patients with primary open-angle glaucoma or ocular hypertension.. This was a double-masked trial conducted at the Hospital Clínico San Carlos, Madrid, Spain. The primary objective of this study was to determine the IOP lowering efficacy of travoprost and latanoprost. During the eligibility visit, patients' IOP was measured throughout two consecutive 24-h periods every 4 h. Patients were then randomized to travoprost or latanoprost (one drop at 8 p.m. daily for 2 weeks). Sixty-two patients were randomized (travoprost n = 32; latanoprost n = 30). IOP was measured at week 2 every 4 h throughout two 24-h periods. All measurements were taken in both supine and sitting positions with the aid of Perkins applanation tonometry. Limitations of the study include a small sample size (due to the difficulty in recruiting patients in a study of this type) which enrolled only Caucasian patients and a short study duration. However, with 25 subjects per group, there was at least 90% power to detect a mean IOP change from baseline of 2.9 mmHg and 80% power to detect a difference of 2.5 mmHg between treatments.. Patients on travoprost therapy showed lower mean IOP levels than those on latanoprost. This difference was statistically significant (p < 0.05) at 12, 16, 20, 24, 36, 40, and 48 h after the last dose for the supine position. The mean IOPs in the supine position throughout the first and the second 24-h period of the week 2 visit as well as for the 48-h visit were statistically lower (p < 0.05) for the travoprost group. Adverse events were mild and included hyperemia and corneal staining. Travoprost and latanoprost were both well tolerated.. Mean IOP values were significantly lower for patients on travoprost for the majority of time points in the supine position.

Topics: Aged; Circadian Rhythm; Cloprostenol; Double-Blind Method; Female; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins F, Synthetic; Travoprost

Changes in intraocular pressure (IOP) are known to be related to visual field deficit progression, although multiple models of this relationship exist. In addition, visual functioning is known to affect medical costs. The objective of this study was to project visual field deficit progression and subsequent costs based on clinical trial data.. Using data from a randomized, 12-month, double-masked study, we compared the use of a fixed combination of travoprost 0.004%/timolol 0.5% (T/T) versus a fixed combination of latanoprost 0.005%/timolol 0.5% (L/T) on visual field deficit progression and associated costs. We applied published algorithms linking IOP to visual field changes to calculate the likelihood of visual field deterioration by treatment group. Differences in medical care costs were estimated using guideline-recommended practice patterns, Medicare hospital costs, and published estimates of differences in hospitalization by visual functioning.. Increase in visual field deficit progression rates, increase in annual hospital days per subject, and increase in annual hospital, outpatient, and total costs per subject.. Predicted visual field deficit progression for T/T patients was less than that for L/T patients (not statistically significant). Projected annual medical care costs were 43 dollars lower for T/T vs. L/T patients.. By applying published algorithms linking IOP to visual field changes, this study projected long-term visual field deficit and associated costs. Use of a fixed travoprost/timolol solution may lead to less long-term visual field deficit progression and lower annual medical care costs than a fixed latanoprost/timolol solution.. The use of clinical trial data may limit the applicability of these findings. However, this analysis of direct medical costs only is likely a conservative estimate of the costs associated with visual field deficits.

Topics: Adult; Aged; Aged, 80 and over; Algorithms; Cloprostenol; Double-Blind Method; Drug Costs; Drug Therapy, Combination; Female; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic; Timolol; Travoprost; Visual Fields

To investigate the efficacy of reducing the drop-skin contact to prevent dermatologic side effects of bimatoprost 0.03% topical therapy.. Prospective, randomized, single-blinded, internally controlled study.. Enrolled subjects started bimatoprost 0.03% therapy once at night in both eyes and were instructed to wipe selectively only one eye (eye 1) with an adsorbent pad during and after drops administration for four months. The fellow eye acted as the internal control. Eyelash growth, regional skin hypertrichosis, and pigmentation on the periocular skin were assessed at baseline and during the four months of follow-up.. A lower incidence of eyelash growth and skin pigmentation in the inferonasal pericanthal region were observed in eye 1. The incidence of pigmentation in the inferotemporal skin region and skin hypertrichosis were similar in the two eyes.. The reduction of the drop-skin contact affects the regional incidence and the extent of dermatologic skin changes that are related to bimatoprost 0.03% topical therapy.

Topics: Adult; Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Disposable Equipment; Eyelashes; Eyelid Diseases; Female; Glaucoma; Hair Diseases; Humans; Hyperpigmentation; Intraocular Pressure; Lipids; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Ophthalmology; Prospective Studies; Single-Blind Method; Skin Care; Skin Pigmentation

To determine if the intraocular pressure (IOP) effect of pilocarpine at various concentrations is additive to that of bimatoprost and to assess the tolerability of this combination.. This was a randomized, prospective trial of patients with IOP > 21 mm Hg following appropriate medication washout. For all visits IOP was measured at 9:00 AM and 11:00 AM. Following baseline visit (#1), bimatoprost 0.03% was instilled qhs OU through visit 6. Following visits 2, 3, and 4 pilocarpine (2%, 4%, 6%) was instilled qid in one randomly selected eye. Pilocarpine was discontinued after visit 5 and bimatoprost after visit 6. Two-tailed, paired t test was used to compare treated and contralateral eyes for their IOP, IOP change, percentage IOP change from baseline, and to compare IOP in the same eye at 9:00 AM and 11:00 AM (before and after pilocarpine administration). IOPs using bimatoprost alone or in combination with various pilocarpine concentrations were compared using single variant Analysis of Variance (ANOVA).. Seventeen patients were enrolled and 13 patients completed the study. Bimatoprost reduced IOP 28.7% to 30.5% (P < 0.0001) from baseline to visit 2. IOPs in eyes treated with bimatoprost alone or with bimatoprost and various pilocarpine concentrations were similar (P > 0.81, ANOVA). The IOP (P > 0.17) and percentage IOP change from baseline (P > 0.10) was similar in treated and contralateral eyes with all three strengths of pilocarpine. IOP values at 9:00 AM and 11:00 AM, before and after pilocarpine administration, were similar (P > 0.22).. Bimatoprost alone reduces IOP substantially. Pilocarpine added to bimatoprost at concentrations of 2%, 4%, or 6% was neither additive nor antagonistic to the ocular hypotensive efficacy of bimatoprost.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Synergism; Drug Therapy, Combination; Female; Glaucoma; Humans; Intraocular Pressure; Lipids; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Pilocarpine; Prospective Studies

Glaucoma is generally managed by decreasing the intraocular pressure (IOP) to a level believed to prevent further damage to the optic disc and loss of visual field. This may be achieved medically or surgically. The objective of this pharmacoeconomic analysis was to investigate the 4-year costs of bimatoprost 0.03% (Lumigan) eye drops as an alternative to filtration surgery (FS) for glaucoma patients on maximum tolerable medical therapy (MTMT).. A Markov model was designed using effectiveness and resource use data from a randomized clinical trial and expert statements (Delphi panel). The RCT covered 83 patients on MTMT. The Model compared bimatoprost with FS. In the bimatoprost model arm patients began treatment with bimatoprost. If target IOP (-20%) was not reached using medical therapy the patient proceeded with FS. In the FS model arm, FS was performed after the first ophthalmologist visit. Unit costs were obtained from an Italian chart and tariffs review (healthcare sector perspective).. The RCT showed that 74.7% of the patients delayed the need for FS by 3 months. The Markov model forecasted that 64.2% of the patients could delay the need for FS by 1 year, and forecasted 34.0% could avoid FS after 4 years. The 4-year cost per patient in the bimatoprost and FS arms was E3438 and E4194, respectively (incremental costs of E755). The major cost drivers for the bimatoprost arm were patients who needed combination therapy or FS if the target IOP was not reached. In the FS arm, the major cost drives were the initial surgery costs and pressure-lowering medications used as add-on therapy after FS.. The analysis shows that in a 4-year perspective bimatoprost is cheaper compared to FS. In addition, the postponement of FS associated with bimatoprost may have important implications for waiting list planning.

Topics: Aged; Amides; Bimatoprost; Cloprostenol; Cost-Benefit Analysis; Filtering Surgery; Glaucoma; Health Care Costs; Humans; Intraocular Pressure; Italy; Lipids; Markov Chains; Ophthalmic Solutions

To evaluate the intraocular pressure- (IOP-) lowering efficacy of bimatoprost 0.03% (Lumigan, Allergan, Inc.) monotherapy in the treatment of patients with glaucoma or ocular hypertension not currently using ocular hypotensives.. Open-label, community-based, multicenter evaluation. Patients (n = 6767) who, according to their physicians, required IOP lowering were prescribed bimatoprost for 2 months. Subgroup analyses of the results, stratified by treatment history and use of concomitant medications, were performed. This report focuses on the subgroup of patients that was not being treated with antiglaucoma medications at baseline (n = 1946, 29%). All of these patients were placed on bimatoprost monotherapy.. The mean IOP at the untreated baseline was 23.8 mmHg. Bimatoprost provided a mean IOP reduction of 7.5 mmHg (30%, p < 0.001) from baseline after 2 months of monotherapy. Further, bimatoprost allowed patients to achieve low target pressures. For example, 41.5% of patients achieved target IOPs of < or =15 mmHg after 2 months of bimatoprost monotherapy, and 75.8% of patients reached IOPs of < or =18 mmHg. The most commonly reported adverse event was conjunctival hyperemia (7.9%).. Bimatoprost monotherapy was well tolerated and reduced IOP by an average of 30% in a large population of untreated patients.

Topics: Amides; Bimatoprost; Cloprostenol; Female; Glaucoma; Humans; Instillation, Drug; Intraocular Pressure; Lipids; Male; Middle Aged; Ocular Hypertension; Treatment Outcome

To determine the mechanism of ocular hypotensive action of bimatoprost in patients with ocular hypertension or glaucoma.. Double-masked, placebo-controlled, randomized, paired comparison crossover study of the effect of bimatoprost on aqueous humor dynamics.. Twenty-nine patients with ocular hypertension or glaucoma.. Bimatoprost and a placebo were administered once a day, in the evening, for 7 days before assessment of aqueous dynamics using tonometry, Schiötz tonography, and fluorophotometry. Intraocular pressure (IOP) response to water drinking was measured.. Aqueous humor flow rate, outflow facility, and IOP.. Intraocular pressure was lowered 29% in the morning and 33% at noon by bimatoprost. Aqueous humor flow was unchanged. Tonographic facility of outflow was increased 47% by bimatoprost relative to the placebo. Assuming an extraocular pressure of 8 mmHg and that extraocular pressure is not altered by bimatoprost, the calculated rate of pressure-insensitive outflow was increased 95% by bimatoprost. During the first hour after water drinking, bimatoprost dampened the IOP rise.. As was seen in healthy normal eyes, bimatoprost increased both the pressure-sensitive and the pressure-insensitive outflows of aqueous humor in patients with ocular hypertension or glaucoma. Bimatoprost had no significant effect on aqueous humor formation.

Topics: Adult; Aged; Amides; Antihypertensive Agents; Aqueous Humor; Bimatoprost; Cloprostenol; Cross-Over Studies; Double-Blind Method; Female; Fluorophotometry; Glaucoma; Humans; Intraocular Pressure; Lipids; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Tonometry, Ocular

Histological changes of, in particular, collagen and extracellular matrix after administration of topical prostaglandin F(2alpha)(PGF (2alpha)) analogues have been reported. In view of this observation, we investigated the influence of PGF(2alpha) analogues on the central corneal thickness.. In a non-randomized, controlled, cross-sectional study, 403 eyes from 208 consecutive patients were examined: 149 eyes (normals/controls) and 79 with ocular hypertension (OHT), 119 eyes with primary open angle glaucoma (POAG) and 56 eyes with normal tension glaucoma (NTG). One experienced ophthalmologist measured the central corneal thickness (CCT) using ultrasound pachymetry (Tomey AL-2000, sequence of 5 measurements with an SD < 3 microm). The central corneal power was measured with the Zeiss keratometer. Depending on the topical treatment, the patients were classified into 4 groups: A) PGF(2alpha) analogues (n = 78), B) carbonic anhydrase inhibitors (n = 26), C) combination of PGF (2)(alpha) analogues and carbonic anhydrase inhibitors (n = 41), D) none of these drugs (n = 258). T tests and multiple linear regression analyses were used for statistical analysis.. CCT was decreased significantly (p < 0.01 each) in eyes treated with PGF(2alpha) analogues (group A: 529 +/- 34 microM), in comparison with the untreated and non-glaucomatous eyes (part of group D: 542 +/- 35 microM, n = 148), untreated glaucomatous/OHT eyes (part of group D: 563 +/- 37 microM, n = 110), eyes treated with carbonic anhydrase inhibitors (group B: 561 +/- 32 microm) and eyes with a topical application of both PGF (2)(alpha) analogues and carbonic anhydrase inhibitors (group C: 555 +/- 48 microM. No correlation was found between CCT and diagnosis (OHT, POAG, NTG, control), gender, central corneal power, and intraocular pressure in a multivariate analysis.. The present findings suggest that the topical application of prostaglandin F(2alpha) analogues onto the cornea reduces the central corneal thickness significantly. These changes might be attributed to effects of PGF(2alpha) analogues on the extracellular matrix of the corneal stroma via upregulation of matrix metalloproteinases. In clinical practice, corneal thinning under local PGF (2)(alpha) analogue treatment could result in underestimation of intraocular pressure levels as measured by applanation tonometry.

Topics: Acetazolamide; Administration, Topical; Adult; Aged; Carbonic Anhydrase Inhibitors; Cloprostenol; Collagen; Cornea; Corneal Topography; Cross-Sectional Studies; Dinoprost; Drug Therapy, Combination; Extracellular Matrix; Female; Glaucoma; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins F, Synthetic; Sulfonamides; Thiophenes; Travoprost; Ultrasonography

To evaluate the safety and efficacy of bimatoprost 0.03% once daily or twice daily compared with timolol 0.5% twice daily in patients with glaucoma or ocular hypertension.. Multicentre, double masked, randomised, parallel group, 3 month trial comparing bimatoprost once daily (n=240), bimatoprost twice daily (n=240), and timolol twice daily (n=122). The primary efficacy end point was diurnal intraocular pressure (IOP) (8 am, 10 am, 4 pm). Safety measures included adverse events, ocular parameters, and systemic variables.. Bimatoprost once daily provided significantly lower mean IOP than timolol twice daily at all times and follow up visits (p<0.001). At month 3, mean IOP reductions from baseline at 10 am (peak timolol effect) were bimatoprost once daily, 8.0 mm Hg (32.4%); bimatoprost twice daily, 6.3 mm Hg (25.2%); timolol, 5.5 mm Hg (22.7%). Bimatoprost twice daily was also more effective than timolol, but was not as effective as bimatoprost once daily. A higher percentage of patients achieved low target pressures with bimatoprost once daily than with timolol. The most frequent side effects with bimatoprost were eyelash growth and mild conjunctival hyperaemia. Systemic safety parameters were not affected by bimatoprost.. Bimatoprost 0.03% once daily demonstrated superior efficacy compared with timolol 0.5% twice daily in patients with elevated IOP. Bimatoprost once daily was more effective than twice daily dosing.

Topics: Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Double-Blind Method; Drug Administration Schedule; Female; Glaucoma; Humans; Intraocular Pressure; Lipids; Male; Middle Aged; Ocular Hypertension; Timolol; Treatment Outcome

To compare the efficacy and safety of topical bimatoprost (LUMIGAN; Allergan, Inc., Irvine, CA) once daily with that of topical combined timolol and dorzolamide (Cosopt; Merck and Co, Inc., Whitehouse Station, NJ) twice daily.. Prospective, randomized, double-masked, multicenter clinical trial.. One hundred seventy-seven patients with a diagnosis of glaucoma or ocular hypertension and inadequate control of intraocular pressure (IOP) after at least 2 weeks of topical timolol maleate 0.5% monotherapy.. Patients were randomized to receive bimatoprost 0.03% once daily (n = 90) or combined timolol 0.5% and dorzolamide 2% twice daily (n = 87) over a 3-month period.. Intraocular pressure, the primary end point, was measured at 8 AM and 10 AM at baseline, week 1, and months 1, 2, and 3, and also at 4 PM and 8 PM at baseline and month 3.. Bimatoprost provided significantly greater IOP lowering compared with combined timolol and dorzolamide. At the 8 AM measurements, bimatoprost lowered mean IOP 6.8 mmHg to 7.6 mmHg from baseline, whereas combined timolol and dorzolamide lowered mean IOP 4.4 to 5.0 mmHg from baseline (P<0.001). At the last follow-up, patients had better diurnal IOP control with bimatoprost than combined timolol and dorzolamide. At 8 AM at the 3-month visit, the percentages of patients achieving IOPs of

Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Double-Blind Method; Drug Combinations; Female; Glaucoma; Humans; Intraocular Pressure; Lipids; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prospective Studies; Safety; Sulfonamides; Thiophenes; Timolol

To compare bimatoprost with timolol maleate in patients with glaucoma or ocular hypertension.. In 2 identical, multicenter, randomized, double-masked, 1-year clinical trials, patients were treated with 0.03% bimatoprost once daily (QD) (n = 474), 0.03% bimatoprost twice daily (BID) (n = 483), or 0.5% timolol maleate BID (n = 241).. Diurnal intraocular pressure (IOP) at 8 AM, 10 AM, and 4 PM and safety variables (IOP was also measured at 8 PM at selected sites).. Bimatoprost QD provided significantly lower mean IOP than timolol at every time of the day at each study visit (P<.001). This was also true for bimatoprost BID at most time points, but the efficacy was not as good as that of the QD regimen. At 10 AM (peak timolol effect) at month 12, the mean reduction in IOP from baseline was 7.6 mm Hg (30%) with bimatoprost and 5.3 mm Hg (21%) with timolol (P<.001). A significantly higher percentage of patients receiving bimatoprost QD (58%) than timolol (37%) achieved IOPs at or below 17 mm Hg (10 AM, month 12; P<.001). The most common adverse effect with bimatoprost was hyperemia (significantly higher with bimatoprost QD than timolol; P<.001).. Bimatoprost QD provides sustained IOP lowering superior to timolol or bimatoprost BID and achieves low target IOPs in significantly more patients.

Topics: Adrenergic beta-Antagonists; Aged; Amides; Bimatoprost; Cloprostenol; Double-Blind Method; Drug Administration Schedule; Female; Glaucoma; Humans; Hyperemia; Intraocular Pressure; Lipids; Male; Middle Aged; Ocular Hypertension; Safety; Timolol; Treatment Outcome

Topics: Adrenergic beta-Antagonists; Amides; Antihypertensive Agents; Bimatoprost; Clinical Trials as Topic; Cloprostenol; Glaucoma; Humans; Intraocular Pressure; Lipids; Ophthalmic Solutions; Timolol

To compare the safety, tolerability, and efficacy of bimatoprost 0.03% instilled once daily or twice daily with timolol 0.5% twice daily.. Multicenter, 3-month, randomized, double-masked, interventional comparison trial.. Patients diagnosed with ocular hypertension or glaucoma (n = 596).. Patients received bimatoprost 0.03% ophthalmic solution once daily (8 PM, with vehicle control at 8 AM), bimatoprost 0.03% twice daily (8 AM; 8 PM), or timolol 0.5% twice daily (8 AM; 8 PM) in an uneven 2:2:1 randomization. Scheduled visits were at prestudy, baseline (day 0), weeks 2 and 6, and month 3. Intraocular pressure (IOP) was measured at 8 AM (predose), 10 AM, and 4 PM.. The primary outcome measure was reduction in IOP in the eye with higher IOP at baseline. Secondary outcome measures included safety variables (adverse events, ophthalmoscopy, biomicroscopy, iris pigmentation, laser-flare meter, visual acuity, visual fields, heart rate, blood pressure, blood chemistry, hematology, and urinalysis).. At month 3, the mean reduction in IOP from baseline at 8 AM was 9.16 mmHg (35.2%) with bimatoprost once daily, 7.78 mmHg (30.4%) with bimatoprost twice daily, and 6.74 mmHg (26.2%) with timolol twice daily. At all follow-up visits, mean IOP reductions were significantly greater in the bimatoprost once daily group than in the timolol group at each time point (8 AM, 10 AM, and 4 PM; P < 0.001). Twice-daily dosing of bimatoprost also provided significantly greater mean reductions in IOP than timolol at most time points but was not as effective as once-daily dosing. Bimatoprost was associated with significantly more hyperemia and eyelash growth than timolol, whereas timolol was associated with significantly more burning and stinging sensation in eyes. Overall, bimatoprost was well tolerated with few discontinuations because of adverse events.. Bimatoprost 0.03% once daily was safe and statistically superior to timolol 0.5% twice daily in lowering IOP in patients with ocular hypertension or glaucoma. Bimatoprost given once daily consistently provided IOP reductions approximately 2 to 3 mmHg greater than those provided by timolol. Once-daily dosing of bimatoprost, 0.03%, demonstrated greater IOP-lowering effect and better ocular tolerability than twice-daily dosing.

Topics: Adult; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Double-Blind Method; Drug Administration Schedule; Female; Glaucoma; Hemodynamics; Humans; Intraocular Pressure; Lipids; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Safety; Timolol; Treatment Outcome; Visual Acuity; Visual Fields

The efficacy and safety of bimatoprost, a member of a new class of pharmacological agents called prostamides, were compared with the efficacy and safety of timolol in patients with glaucoma or ocular hypertension. Pooled 6-month results from two ongoing, multicenter, randomized, double-masked, clinical trials were analyzed. Patients were randomized in a 2:2:1 ratio to treatment with bimatoprost 0.03% once a day ([QD] n = 474), bimatoprost 0.03% twice a day ([BID] n = 483), or timolol 0.5% BID (n = 241). Scheduled visits were at prestudy, baseline, week 2, week 6, month 3, and month 6. The primary outcome measure was in diurnal intraocular pressure ([IOP] 8 AM, 10 AM, 4 PM, 8 PM). Bimatoprost QD provided significantly greater mean IOP reductions from baseline than timolol at every time of the day and at each study visit (p

Topics: Adrenergic beta-Antagonists; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Conjunctiva; Double-Blind Method; Eye Color; Female; Glaucoma; Humans; Hyperemia; Intraocular Pressure; Iris; Lipids; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Safety; Timolol

Benzalkonium chloride (BAK), the most commonly used preservative in anti-glaucoma eye drops, inflicts damage to the ocular surface. A novel anti-glaucoma formulation that avoids the use of BAK has been developed. The aim of this study was to evaluate the cytotoxicity of this formulation and to compare it with an ophthalmic solution containing BAK.. Two different latanoprost eye drops were used: one ophthalmic solution (LSc) containing BAK 0.02% and one ophthalmic nanoemulsion (LNe) with a soft preservative (potassium sorbate 0.18%). Human epithelial conjunctival cells were incubated for 15, 30, and 60 min with either LSc or LNe. The cytotoxicity was determined by MTT assay. Cell death was measured by flow cytometry using annexin V-FITC and propidium iodide.. The values of cell viability and proliferation obtained from cells exposed to LNe were between 80 and 90% relative to the control group, whereas values obtained from cells exposed to LSc were around 30% at all study times (p < 0.05 at 15 and 30 min; p < 0.01 at 60 min). The percentage of viable cells decreased significantly when cells were incubated with LSc compared with cells incubated with LNe at all the study times, while the percentage of cells in late apoptosis/necrosis increased significantly in cells exposed to LSc compared to LNe.. The new latanoprost nanoemulsion is significantly less cytotoxic on human conjunctival cells than LSc. These results suggest that the new formulation might be gentler on the eye surface than currently available BAK-preserved latanoprost solutions.

Topics: Antihypertensive Agents; Benzalkonium Compounds; Cloprostenol; Conjunctiva; Glaucoma; Humans; Latanoprost; Ophthalmic Solutions; Preservatives, Pharmaceutical; Prostaglandins F, Synthetic; Travoprost

To measure the magnitude and duration of the hypotensive effect of two prostaglandin analogues in glaucoma patients using the water drinking test (WDT).. Patients received latanoprost or travoprost every 24 h and then every 48 h. Untreated WDT were performed at 7 am and with treatment 12, 36 and 44 h after the last dose; intraocular pressure (IOP) peak, fluctuation and the difference between peak and isolated IOP measurements at consultation times were calculated.. Forty-one eyes of 21 patients with primary open-angle glaucoma were included; 22 eyes received latanoprost, and 19 received travoprost. Mean untreated isolated IOP was 17.20 standard deviation (S.D.) 3.73 and 16.95 S.D. 2.61 mmHg and peak pressure 22.45 S.D. 2.91 and 21.58 S.D. 3.79 mmHg, for the latanoprost and travoprost groups, respectively. With treatment, peak pressure was reduced by 22.64% and 20.29% at 12 h, 18.44% and 14.64% at 36 h and 16.17% and 14.46% at 44 h, respectively. The fluctuation without treatment was 4.36 and 5.11 mmHg, and with treatment at 12 h was reduced to 2.77 and 2.89 mmHg, increasing again at 36 and 44 h.. A hypotensive effect was evident up to 44 h after the last dose of latanoprost and travoprost, similar for the two drugs and decreasing over time. IOP fluctuation was only reduced at 12 h.

Topics: Antihypertensive Agents; Cloprostenol; Glaucoma; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Prostaglandins F, Synthetic; Water

Bimatoprost 0.03% is an intraocular pressure (IOP) lowering prostaglandin analog with different adverse side effects such as potential ocular inflammatory effect and ocular hyperemia.. We report a case of 80-year-old woman diagnosed with bilateral glaucomatous uveitis, and choroidal detachment in the left eye after topical bimatoprost administration. During the patient's hospitalization, Bimatoprost treatment was discontinued and local steroid therapy was administrated. After 1 week we reported a marked improvement of visual acuity, IOP measurement was 12 mmHg in both eyes. Anterior segment examination showed complete resolution of conjunctival and pericheratic hyperemia with significant reduction of endothelial precipitates in both eyes.. In our case, the anterior granulomatous uveitis occurred in both pseudophakic eyes and the choroidal detachment (CD) in the eye that previously had trabeculectomy. Probably the scar tissue of the trabeculectomy allowed a better penetration of the Bimatoprost or a greater sensitivity due to an altered trabecular tissue. This work confirms that the onset physiopathology mechanism of granulomatous uveitis and CD following instillation of Bimatoprost remains uncertain.

Topics: Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Choroidal Effusions; Cloprostenol; Female; Glaucoma; Humans; Hyperemia; Intraocular Pressure; Uveitis; Uveitis, Anterior

The distribution of prostaglandin-associated periorbitopathy (PAP) graded using the Shimane University PAP Grading System (SU-PAP) among glaucoma/ocular hypertension subjects using a topical FP or EP2 receptor agonist was reported. A 460 consecutive 460 Japanese subjects (211 men, 249 women; mean age ± standard deviation, 69.9 ± 14.5 years) who had used either a FP agonist (0.005% latanoprost, 0.0015% tafluprost, 0.004% travoprost, 0.03% bimatoprost, or fixed combinations of these) or EP2-agonist (0.002% omidenepag isopropyl) for more than 3 months in at least 1 eye were retrospectively enrolled. Age, sex, prostaglandin, intraocular pressure (IOP) measured by Goldmann applanation tonometry (IOPGAT) and iCare rebound tonometry (IOPRBT), difference between IOPGAT and IOPRBT (IOPGAT-RBT), PAP grade, and PAP grading items were compared among groups stratified by PAP grade or prostaglandins. Of the study patients, 114 (25%) had grade 0 (no PAP), 174 (38%) grade 1 (superficial cosmetic PAP), 141 (31%) grade 2 (deep cosmetic PAP), and 31 (7%) grade 3 (tonometric PAP). The IOPGAT was significantly higher in grade 3 (17.5 ± 5.4 mm Hg) than grades 0 (15.0 ± 5.1 mm Hg, P = .032) and 1 (14.5 ± 4.2 mm Hg, P = .008), and the IOPGAT-RBT was significantly higher in grade 3 (5.8 ± 3.2 mm Hg) than the other 3 grades (1.3-1.9 mm Hg, P < .001 for all comparisons); the IOPRBT was equivalent among the 4 grades. The PAP grade was significantly higher associated with travoprost (2.0 ± 0.8) and bimatoprost (2.0 ± 0.7) than latanoprost (1.0 ± 0.8, P < .001 for both comparisons) and tafluprost (1.0 ± 0.7, P < .001 for both comparisons), but significantly lower associated with omidenepag (0.0 ± 0.0, P < .001 for all comparisons) than the other 4 prostaglandins. Multivariate analyses showed older age (standard β = 0.11), travoprost (0.53, referenced by latanoprost) and bimatoprost (0.65) were associated with higher PAP grades, while tafluprost (-0.18) and omidenepag (-0.73) were associated with lower PAP grades. The PAP graded using SU-PAP reflects the degree of overestimation of the IOPGAT and different severities of PAP among the different prostaglandins. SU-PAP, the grade system constructed based on the underlining mechanisms of PAP, is a simple grading system for PAP that is feasible for use in a real-world clinical situation.

Topics: Age Factors; Aged; Aged, 80 and over; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Combinations; Female; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Male; Manometry; Middle Aged; Ocular Hypertension; Orbital Diseases; Prostaglandins F; Prostaglandins, Synthetic; Retrospective Studies; Severity of Illness Index; Sex Factors; Travoprost

To investigate the association between patterns of eye drop prescription and medication usage in patients with glaucoma.. Sixty-seven Japanese patients with glaucoma who were prescribed topical antiglaucoma medications including a prostaglandin analogue bilaterally for >6 months at Nayoro City General Hospital, Nayoro, Japan, were included in the study. A self-administered, 5-item patient questionnaire was administered to determine how patients routinely use medications, including the method of eye drop administration, number of eye drops per instillation, accuracy of eye drop placement, weekly frequency of eye drop application, and their awareness of local side effects. The number of prostaglandin analogue bottles prescribed monthly was compared in each factor.. The mean patient age was 74.4±10.0 years (range, 52 to 95 y; 39 women, 28 men). The mean duration of glaucoma treatment was 4.2±3.2 years (range, 0.7 to 10.6 y). Patients who placed the eye drops outside the eye were prescribed significantly more bottles monthly (P=0.008). The other factors had no significant effect on the number of bottles prescribed monthly.. Patients with glaucoma who used eye drops incorrectly were routinely prescribed additional bottles of eye drops. Ophthalmologists should determine whether patients who request an unusual number of eye drops are using the eye drops correctly.

Topics: Administration, Topical; Aged; Aged, 80 and over; Antihypertensive Agents; Cloprostenol; Drug Prescriptions; Female; Glaucoma; Humans; Intraocular Pressure; Japan; Latanoprost; Male; Medication Adherence; Middle Aged; Ophthalmic Solutions; Prostaglandins F; Prostaglandins F, Synthetic; Surveys and Questionnaires; Travoprost

We investigated the transcorneal penetration of commercial ophthalmic formulations containing timolol maleate in rabbit eyes.. One drop (30 μL) of each ophthalmic solution (Xalacom(®), DuoTrav(®), Cosopt(®), and Timoptol(®)) was administered to the conjunctival sac of the rabbits' eyes and the timolol maleate aqueous humor concentration was measured by high-performance liquid chromatography 15, 60, 120, and 240 min after the completion of administration. The effect of timolol ophthalmic solution pH (5.7-6.8) on ocular penetration was also examined.. The concentration [Cmax (μg/mL)] of timolol maleate, found in each of the 4 ophthalmic solutions, penetrated to the aqueous humor was as follows: DuoTrav>Cosopt>Timoptol>Xalacom. The concentration of timolol maleate penetrated to the aqueous humor was highest with solutions in the vicinity of pH 6.8.. The concentration of timolol maleate penetrated to the aqueous humor was highest in DuoTrav followed by Cosopt, Timoptol, and Xalacom, and the pH and Benzalkonium chloride (BAK) concentration of the ophthalmic solution were believed to be factors that influenced this phenomena.

Topics: Animals; Benzalkonium Compounds; Chromatography, Liquid; Cloprostenol; Cornea; Drug Combinations; Eye; Glaucoma; Male; Ophthalmic Solutions; Preservatives, Pharmaceutical; Prostaglandins F, Synthetic; Rabbits; Sulfonamides; Thiophenes; Timolol

To determine whether the aqueous levels of matrix metalloproteinases (MMPs) differ between patients with glaucoma treated with topical prostaglandin analogues and normal, nonglaucomatous control patients. Also, to note any difference in MMP levels between latanoprost, travoprost, and bimatoprost that might suggest a difference in efficacy or mechanism of action between these drugs.. Prospective, observational study.. Patients who were scheduled to undergo routine intraocular surgery (phacoemulsification or combined phacotrabeculectomy) as part of their standard clinical care were included. Eighteen eyes of 18 patients with glaucoma using any 1 prostaglandin analogue (latanoprost, travoprost, or bimatoprost) were compared with 8 normal control patients.. This was a multicentre study. Aqueous humour (0.2 mL) was aspirated at the beginning of the intraocular surgery through a clear corneal paracentesis. MMP-2 and -9 were quantified in the aqueous of all participants using enzyme-linked immunosorbent assay.. There was no significant difference in the levels of either MMP-2 (p = 0.216) or MMP-9 (p = 0.552) between the control patients and the patients with glaucoma on prostaglandins. There was no difference in the levels of MMP-2 or -9 between the latanoprost, travoprost, or bimatoprost groups.. The levels of MMP-2 and -9 in aqueous of glaucomatous eyes on topical prostaglandin analogues were the same as those of normal age-matched control patients. This could reflect either a return to normal levels with efficacious treatment or a lack of difference between disease and nondisease states.

Topics: Administration, Topical; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Aqueous Humor; Bimatoprost; Cloprostenol; Enzyme-Linked Immunosorbent Assay; Female; Glaucoma; Humans; Latanoprost; Male; Matrix Metalloproteinase 2; Matrix Metalloproteinase 9; Middle Aged; Ophthalmic Solutions; Prospective Studies; Prostaglandins F, Synthetic; Travoprost

This study discussed about the influence of local application of glaucoma medications -- travoprost eye drops to patients' tear film function. We selected 24 patients, 45 eyes with primary open-angle glaucoma or intraocular hypertension. All of the patients topically used the travoprost eye drops for one time every night. After and before the pharmacy, we proceeded 1, 2, 3 mo lines symptom score and Schirmer's test (St), corneal fluorescein staining (FL), breakup time of tear film (BUT). Average value of symptom score and FL of all the patients before pharmacy were 1.32 ± 1. 55, 0.42 ± 0.68, and 1, 2, 3mo after pharmacy were respectively 2.68 ± 1.59, 0.96 ± 0.81; 4.97 ± 1.62, 1.46 ± 0.62; 6.21 ± 1.33, 1.88 ± 0.44. Symptom score and FL of 1, 2, 3 mo patients after pharmacy were all prominent higher than it before pharmacy (P=0.00), and it gradually increased. The average value of patients symptom BUT and St before pharmacy were (7.71 ± 0.87s), (8.32 ± 2.63mm /5min) and 1, 2, 3 mo after pharmacy were respectively (6.93 ± 1.17s), (7.69 ± 3. 33mm /5min); (5.48 ± 1.29s), (6.79 ± 2.94mm /5min); (4.33 ± 1.83s), (5.98 ± 3.11mm/5min). BUT and St value after pharmacy were prominent all lower than the level before pharmacy (P=0.00). And it gradually reduced. Short-term use of travoprost eye drops would aggravate the corneal irritation of patients, and decrease the tear film stability and tear secretion.

Topics: Administration, Ophthalmic; Adult; Aged; Cloprostenol; Cornea; Drug Administration Schedule; Female; Glaucoma; Humans; Intraocular Pressure; Lacrimal Apparatus; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Tears; Time Factors; Travoprost; Treatment Outcome; Young Adult

To evaluate the periocular changes due to topical bimatoprost and latanoprost use and to investigate their effects on the lacrimal drainage system.. All participants (69 eyes of 43 patients, 52 eyes of 26 controls) were classified into three groups: bimatoprost (0.03%) users, latanoprost (0.005%) users, and healthy controls. Each patient was examined before prostaglandin therapy, and then at the first, third, sixth, and twelfth month of therapy. Palpebral fissure height, upper eyelid crease, and levator function were measured, and lacrimal system drainage irrigation was performed. Periocular hyperpigmentation and upper eyelid sulcus were also examined.. No significant change was identified in palpebral fissure height or levator function in any group. However, in upper eyelid crease, among bimatoprost users, a statistically significant increase was observed when compared to the control group (P < 0.001). Patients with skin type II and III, in bimatoprost users, and patients with skin type III, in latanoprost users, had statistically significant hyperpigmentation (P < 0.001) after the third month of therapy. During follow-up, no lacrimal drainage system obstruction was seen.. Topical bimatoprost therapy causes more periocular changes than latanoprost therapy. Thus, in unilateral cases, patients should be well informed about these probable changes before therapy.

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Eyelid Diseases; Female; Glaucoma; Humans; Hyperpigmentation; Incidence; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prospective Studies; Prostaglandins F, Synthetic; Turkey

To investigate the frequency of prostaglandin-associated periorbitopathy among bimatoprost, latanoprost and travoprost users.. Retrospective observational case series.. The study group included 105 patients who were using one of the drugs in one eye for more than 1 month, and the other eye was used as a control.. The frequency of prostaglandin-associated periorbitopathy.. Special care was taken to detect five prostaglandin-associated periorbitopathy findings. Hertel exophthalmometry measurements and colour pictures of the periocular area were taken.. Statistically significant differences were found among the groups regarding the presence of all prostaglandin-associated periorbitopathy findings (P < 0.05). Periorbital fat loss was the most frequent and was observed in nearly all prostaglandin-associated periorbitopathy patients except those who were relatively young. The overall frequency of prostaglandin-associated periorbito pathy was 93.3% in the bimatoprost group, 41.4% in the latanoprost group and 70% in the travoprost group. The frequency of deepening of the upper lid sulcus was 80% in the bimatoprost group, 15.7% in the latanoprost group and 45% in the travoprost group. The frequency of milder changes (the presence of either only periorbital fat loss or dermatochalasis involution or the presence of both) was higher in the latanoprost group (62%) than in the travoprost (35.7%) and bimatoprost (7.1%) groups.. Prostaglandin-associated periorbitopathy is as common as other adverse effects when careful examinations are performed and is more frequent and more severe in bimatoprost users. The loss of the periorbital fat pad is the first sign to occur during the evolution of prostaglandin-associated periorbitopathy, especially in older patients.

Topics: Adolescent; Adult; Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Eyelid Diseases; Female; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Orbital Diseases; Prostaglandins F, Synthetic; Retrospective Studies; Travoprost; Young Adult

Topics: Antihypertensive Agents; Cloprostenol; Drugs, Generic; Glaucoma; Humans; Prostaglandins F, Synthetic

Topics: Antihypertensive Agents; Cloprostenol; Drugs, Generic; Glaucoma; Humans; Prostaglandins F, Synthetic

The purpose of the present study was to develop and assess a novel sustained-release drug delivery system of Bimatoprost (BIM). Chitosan polymeric inserts were prepared using the solvent casting method and characterized by swelling studies, infrared spectroscopy, differential scanning calorimetry, drug content, scanning electron microscopy and in vitro drug release. Biodistribution of 99mTc-BIM eye drops and 99mTc-BIM-loaded inserts, after ocular administration in Wistar rats, was accessed by ex vivo radiation counting. The inserts were evaluated for their therapeutic efficacy in glaucomatous Wistar rats. Glaucoma was induced by weekly intracameral injection of hyaluronic acid. BIM-loaded inserts (equivalent to 9.0 µg BIM) were administered once into conjunctival sac, after ocular hypertension confirmation. BIM eye drop was topically instilled in a second group of glaucomatous rats for 15 days days, while placebo inserts were administered once in a third group. An untreated glaucomatous group was used as control. Intraocular pressure (IOP) was monitored for four consecutive weeks after treatment began. At the end of the experiment, retinal ganglion cells and optic nerve head cupping were evaluated in the histological eye sections. Characterization results revealed that the drug physically interacted, but did not chemically react with the polymeric matrix. Inserts sustainedly released BIM in vitro during 8 hours. Biodistribution studies showed that the amount of 99mTc-BIM that remained in the eye was significantly lower after eye drop instillation than after chitosan insert implantation. BIM-loaded inserts lowered IOP for 4 weeks, after one application, while IOP values remained significantly high for the placebo and untreated groups. Eye drops were only effective during the daily treatment period. IOP results were reflected in RGC counting and optic nerve head cupping damage. BIM-loaded inserts provided sustained release of BIM and seem to be a promising system for glaucoma management.

Topics: Administration, Ophthalmic; Amides; Animals; Bimatoprost; Calorimetry, Differential Scanning; Cloprostenol; Delayed-Action Preparations; Drug Delivery Systems; Glaucoma; Humans; In Vitro Techniques; Intraocular Pressure; Male; Microscopy, Electron, Scanning; Rats; Rats, Wistar; Spectroscopy, Fourier Transform Infrared; Tissue Distribution

To develop and validate a predictive model to estimate the probability of being nonadherent to topical glaucoma medications.. Prospective cohort study.. Patients being treated with once-daily prostaglandin eye drops.. A predictive model for nonadherence was developed from the Travatan Dosing Aid (TDA) study (n = 196) using stepwise logistic regression. The performance of the TDA-derived model was assessed using a separate cohort of subjects from the Automated Dosing Reminder Study (ADRS; n = 407). The assessment was based on regression coefficients, discrimination, and calibration. We also developed a scoring system from the TDA-derived model to simplify the estimation of risk for clinical use.. Usage of drops was monitored electronically for 3 months in both studies. Adherence was calculated as the percentage of days on which a dose was taken within 4 hours of the average dosing time for that patient. Nonadherence was defined as taking ≤ 75% prescribed doses within a window starting 2 weeks after the baseline visit until 2 weeks before the follow-up visit.. Six factors, including younger age, black race, worse general health status, shorter duration of glaucoma medication therapy, lower self-reported adherence, and admitting to not following doctors' orders, were associated with being nonadherent and were included in the predictive model. The coefficients for the TDA-derived and the ADRS-derived predictive models were similar. The risk scoring system developed from the TDA study had good discrimination (area under the receiver operating characteristic curve of 0.80) and calibration (Hosmer-Lemeshow goodness-of-fit test, P = 0.102) when applied to the ADRS population.. The TDA-derived predictive model for nonadherence performed well in an independent population. A risk scoring system was developed using demographic data and patient responses to 4 questions to provide an estimate of the probability of being nonadherent.

Topics: Administration, Topical; Aged; Antihypertensive Agents; Cloprostenol; Cohort Studies; Drug Monitoring; Female; Glaucoma; Humans; Intraocular Pressure; Male; Medication Adherence; Middle Aged; Models, Statistical; Ophthalmic Solutions; Probability; Prospective Studies; Risk Assessment; ROC Curve; Travoprost

We studied the relation between prostaglandin analogue use and ocular adnexal features. We used a prospective, cross-sectional study involving 157 current, 15 past, and 171 never users of prostaglandin analogues. Patients 50 years of age or older and without conditions affecting ocular adnexal anatomy underwent glaucoma medication use history, external digital photography and systematic external adnexal exam. Two masked readers assessed the digital photos for upper lid dermatochalasis and lower lid steatoblepharon using a validated grading scheme. Another masked clinical examiner also assessed upper lid ptosis, levator muscle function, and inferior scleral show. We performed ordinal logistic regression analysis accounting for multiple covariates to assess the relation between prostaglandin analogue use and adnexal features. Multivariable analyses indicated there was a 230-fold increased risk of incremental involution of dermatochalasis (odds ratio (OR) = 2.30; 95% confidence interval (CI) 1.43-3.69; p = 5.44E-04) and a 249-fold increased risk of incremental loss of lower lid steatoblepharon (OR = 2.49; 95% CI, 1.54-4.03; p= 1.98E-04) associated with current prostaglandin analogue use (bimatoprost 0.03%, travoprost 0.005%, or latanoprost 0.004%) versus prostaglandin analogue never or past users. Upper lid ptosis (OR = 4.04; 95% CI, 2.43-6.72; p = 7.37E-08), levator dysfunction (OR = 7.51; 95% CI, 3.39-16.65; p = 6.74E-07) and lower lid retraction (OR = 2.60; 95% CI, 1.58-4.28; p = 1.72E-04) were highly associated with current prostaglandin analogue use versus prostaglandin analogue never or past users. The associations between prostaglandin analogue use and deepening of the upper lid sulci and between prostaglandin analogue use and loss of inferior periorbital fat are confirmed in this multivariable analysis. The associations between prostaglandin analogue use and levator muscle dysfunction and between prostaglandin analogue use and upper lid ptosis represent significant side effects that could impact visual function in glaucoma patients.

Topics: Amides; Bimatoprost; Cloprostenol; Cross-Sectional Studies; Eyelids; Glaucoma; Humans; Latanoprost; Multivariate Analysis; Prospective Studies; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Skin Abnormalities; Subcutaneous Fat; Travoprost

Topics: Antihypertensive Agents; Cloprostenol; Drugs, Generic; Glaucoma; Humans; Latanoprost; Prostaglandins F, Synthetic

Topics: Antihypertensive Agents; Cloprostenol; Drug Costs; Drugs, Generic; Glaucoma; Humans; Latanoprost; Ophthalmic Solutions; Prostaglandins F, Synthetic

Eighty-two-year-old patient with a pacemaker using warfarin due to arrhythmia and having an intraocular lens in the right eye, developed spontaneous hemorrhagic choroidal detachment one day after the use of combined preparation of 0.5% timolol maleate and 0.004% travoprost, due to primary open-angle glaucoma. Hemorrhagic detachment was detected by anterior and posterior segment examination, as well as B-scan ultrasonography. After the detachment, excessive increased intraocular pressure was controlled with oral carbonic anhydrase inhibitor, cycloplegic and steroid therapy. After four months, visual acuity was 20/20 and the intraocular pressure was under control with 0.5% timolol maleate and 1% brinzolamide. Controlled reduction of the intraocular pressure should be considered, particularly in older patients under anticoagulant therapy and that had undergone prior ocular surgery.

Topics: Aged, 80 and over; Antihypertensive Agents; Choroid; Choroid Hemorrhage; Cloprostenol; Glaucoma; Humans; Intraocular Pressure; Male; Ophthalmic Solutions; Timolol; Travoprost; Ultrasonography

Prostaglandin F(2)α analogs (PGAs), including latanoprost, travoprost and bimatoprost, the first choice for the pharmaceutical treatment of glaucoma, are gaining more attention on their systemic side effects in recent years. The gastro-intestinal effects are among the most reported adverse effects upon topical application of PGAs. Yet, the underlying mechanism remains to be unknown. In the current study, we performed a molecular genetic analysis on the patient reported by Yu et al. (BMJ Case Rep, 2009), who developed nausea, vomiting and diarrhea after topical application of travoprost and latanoprost, but not bimatoprost, and then speculated that the mechanism underlying the gastro-intestinal distress secondary to PGA topical application should be attributed to their stimulation of smooth muscles of the gastric and intestinal tract via prostanoid receptors. We postulate that the diversified receptor selectivity of various PGAs might mediate their diversified gastro-intestinal effects. To further verificate the speculation, other three glaucoma patients who exhibited different gastro-intestinal responses to different PGA medications were enrolled. The results suggested that the relative expression level of FP receptor, versus EP receptors, might be associated with the severity of gastro-intestinal effects incurred by PGAs. Owing to the differed expression levels of FP receptor, the responses of various patients to different PGAs can be variable.

Topics: Administration, Topical; Aged; Amides; Base Sequence; Bimatoprost; China; Cloprostenol; Diarrhea; Female; Gastrointestinal Tract; Glaucoma; Humans; Latanoprost; Male; Middle Aged; Molecular Sequence Data; Muscle, Smooth; Nausea; Prostaglandins F, Synthetic; Receptors, Prostaglandin; Receptors, Prostaglandin E; Sequence Analysis, DNA; Travoprost; Vomiting

Balding causes widespread psychological distress but is poorly controlled. The commonest treatment, minoxidil, was originally an antihypertensive drug that promoted unwanted hair. We hypothesized that another serendipitous discovery, increased eyelash growth side-effects of prostamide F(2α)-related eyedrops for glaucoma, may be relevant for scalp alopecias. Eyelash hairs and follicles are highly specialized and remain unaffected by androgens that inhibit scalp follicles and stimulate many others. Therefore, we investigated whether non-eyelash follicles could respond to bimatoprost, a prostamide F(2α) analog recently licensed for eyelash hypotrichosis. Bimatoprost, at pharmacologically selective concentrations, increased hair synthesis in scalp follicle organ culture and advanced mouse pelage hair regrowth in vivo compared to vehicle alone. A prostamide receptor antagonist blocked isolated follicle growth, confirming a direct, receptor-mediated mechanism within follicles; RT-PCR analysis identified 3 relevant receptor genes in scalp follicles in vivo. Receptors were located in the key follicle regulator, the dermal papilla, by analyzing individual follicular structures and immunohistochemistry. Thus, bimatoprost stimulates human scalp follicles in culture and rodent pelage follicles in vivo, mirroring eyelash behavior, and scalp follicles contain bimatoprost-sensitive prostamide receptors in vivo. This highlights a new follicular signaling system and confirms that bimatoprost offers a novel, low-risk therapeutic approach for scalp alopecias.

Topics: Administration, Topical; Adult; Alopecia; Amides; Animals; Antihypertensive Agents; Base Sequence; Bimatoprost; Cloprostenol; Female; Glaucoma; Hair Follicle; Humans; Immunohistochemistry; Male; Mice; Middle Aged; Organ Culture Techniques; Receptors, Prostaglandin; RNA, Messenger; Scalp; Young Adult

To investigate the toxic-inflammatory effects of prostaglandin analogs on the ocular surface.. Twenty-three rats were divided into four groups. Bimatoprost 0.03% (I), latanoprost 0.005% (II), and travoprost 0.004% (III) were applied during 6 months; a control group (IV) received no treatment. Dysplasia and keratinization were evaluated on the ocular surface. In the subepithelial area, the number of lymphocytes and mast cells were counted morphologically, and collagen staining densities were compared subjectively in groups.. The ratio of keratinization was 3/12 and 1/10, in groups I and II. The lymphocyte cell counts were 1.4 ± 0.19, 2.2 ± 0.39, 2.27 ± 0.33, and 1.87 ± 0.35 (p > .05). The mast cell counts were 2.58 ± 0.5, 5.4 ± 1.1, 5.7 ± 0.58, and 3.0 ± 0.59. They were significantly higher in groups II and III than in group I (p < .05). Mean collagen density scores were 1.00 ± 0.85, 2.00 ± 0.00, and 1,73 ± 0.70. Group II and III scores were higher than group I scores (p < .05).. Latanoprost and travoprost seem to have more toxic-inflammatory effects on the ocular surface than bimatoprost.

Topics: Amides; Animals; Antihypertensive Agents; Bimatoprost; Cloprostenol; Conjunctiva; Conjunctival Diseases; Cornea; Corneal Diseases; Disease Models, Animal; Follow-Up Studies; Glaucoma; Intraocular Pressure; Latanoprost; Male; Ophthalmic Solutions; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Rats; Rats, Wistar; Travoprost

Adherence to long-term treatment regimens for primary open-angle glaucoma holds a challenge for both clinicians and patients. The study aims were to (i) establish the magnitude of travoprost non-adherence using an Electronic Adherence Monitor (EAM), (ii) compare electronic with patient self-reported adherence, and (iii) explore the application of a previously reported method of graphically presenting adherence data to a larger cohort over a longer monitoring period.. A cohort study of patients using travoprost for glaucoma or ocular hypertension was conducted. All participants used an EAM and adherence data were collected prospectively for 2 months. Self-reported adherence was obtained using the Morisky Medication Adherence Scale (MMAS); patients also reported frequency of missed doses. Potential predictors of adherence were collected via a structured interview. EAM-recorded interdose intervals were plotted graphically.. Of 100 patients invited to participate, 98 consented and EAM data were collected successfully from 88 participants. The median EAM adherence score for the cohort was 88.9% (interquartile range: 71.2, 92.2). When dichotomised (≥80%: adherent; <80%: non-adherent), EAM identified 36.7% as non-adherent and MMAS 12.2%. EAM data were used to classify five types of adherence behaviour including a category representing levels of ≥97% maintained by 21% of participants.. EAM revealed good adherence to glaucoma monotherapy but poor agreement with patient self-reported adherence. An adherence category of persistent and exceptionally high adherence to travoprost over a 2-month period was identified.

Topics: Aged; Aged, 80 and over; Antihypertensive Agents; Cloprostenol; Cohort Studies; Female; Glaucoma; Humans; Logistic Models; Male; Medication Adherence; Middle Aged; Self Report; Travoprost

The 17-phenyl PGF(2α) analogue bimatoprost (10a) is the most efficacious ocular hypotensive agent currently available for the treatment of glaucoma or ocular hypertension. A novel convergent synthesis of 13,14-en-15-ol prostamideF(2α) analogues was developed employing Julia-Lythgoe olefination of the structurally advanced phenylsulfone (+)-(5Z)-15 with an enantiomerically pure aldehyde ω-chain synthon (-)-(S)-16a. Subsequent hydrolysis of protecting groups and final amidation of the diol 26a yielded bimatoprost (10a). The main advantage of the current strategy is the preparation of high-purity bimatoprost (10a). The novel convergent strategy allows the synthesis of a whole series of 13,14-en-15-ol prostamideF(2α) analogues with the desired C-15 asymmetric center configuration from a common and structurally advanced prostaglandin intermediate (+)-(5Z)-15. The preparation and identification of two synthetic impurities, 15-epi isomer (10b) of bimatoprost and a new prostaglandin related amide (+)-(5Z)-18, are also described.

Topics: Amides; Bimatoprost; Cloprostenol; Dinoprost; Glaucoma; Molecular Structure

Topics: Aged; Amides; Bimatoprost; Cleft Palate; Cloprostenol; Cough; Glaucoma; Humans; Male; Mucus; Ophthalmic Solutions; Palatal Obturators

To determine whether the intraocular penetration of travoprost 0.004% is affected by central corneal thickness.. Sixty-four patients who were scheduled for cataract surgery without any other ophthalmologic pathology of significance were enrolled in this study. At 120 min before surgery, one drop of travoprost 0.004% was instilled in the eye to be operated on. At the start of surgery, a sample of aqueous humour was extracted to subsequently determine its AL-5848 concentration. These concentrations were compared among three groups of patients established according to central corneal thickness measurements obtained by ultrasound pachymetry.. Mean AL-5848 concentrations were 3.27±2.03 ng/ml in Group I (CCT<511 microns), 3.27±2.44 ng/ml in Group II (CCT≥511 and ≤574 microns), and 2.73±2.15 ng/ml in Group III (CCT>574 microns), indicating no significant differences among the groups.. We were unable to demonstrate the greater or lesser penetration of travoprost depending on corneal thickness, which could explain differences in patient responses to this drug.

Topics: Adult; Antihypertensive Agents; Aqueous Humor; Cloprostenol; Cornea; Female; Glaucoma; Humans; Male; Travoprost

Examination of the response of the retinal proteome to elevated intraocular pressure (IOP) and to the pharmacological normalization of IOP is crucial, in order to develop drugs with neuroptorective potential. We used a hereditary rat model of ocular hypertension to lower IOP with travaprost and dorzolamide applied topically on the eye surface, and examine changes of the retinal proteome. Our data demonstrate that elevated IOP causes alterations in the retinal protein profile, in particular in high-mobility-group-protein B1 (HMGB1), calmodulin, heat-shock-protein (HSP) 70 and carbonic anhydrase II expression. The changes of the retinal proteome by dorzolamide or travoprost are different and independent of the IOP lowering effect. This fact suggests that the eye drops exert a direct IOP-independent effect on retinal metabolism. Further investigations are required to elucidate the potential neuroprotective mechanisms signaled through changes of HMGB1, calmodulin, HSP70 and carbonic anhydrase II expression in glaucoma. The data may facilitate development of eye drops that exert neuroprotection through direct pharmacological effect.

Topics: Animals; Calmodulin; Carbonic Anhydrase II; Cloprostenol; Disease Models, Animal; Glaucoma; HMGB1 Protein; HSP70 Heat-Shock Proteins; Intraocular Pressure; Ophthalmic Solutions; Peptide Mapping; Proteome; Proteomics; Rats; Retina; Sulfonamides; Thiophenes; Travoprost

The prostaglandin F2a (PGF2a) analogue bimatoprost 0.03% (Allergan, Inc, Irvine, California) has been employed for the treatment of hypotrichosis since it gained Food and Drug Administration approval as Latisse in 2008. In this report, the authors retrospectively review the cases of 7 patients who presented to their outpatient ophthalmology clinic with glaucoma. These patients had periorbital hollowing due to fat atrophy as a side effect of topical ophthalmic bimatoprost therapy. The series of patients described in this report emphasizes the small but significant risk of periocular fat changes associated with bimatoprost 0.03%, which is the exact formulation marketed as Lumigan for glaucoma treatment. Patients using Latisse for its cosmetic enhancement of eyelash length should be warned of this potentially disfiguring side effect, since the cosmetic and ophthalmic preparations are identical. Such changes can be irreversible, and the implications of the decision to prescribe this drug either in the form of an eyelash application or for topical ophthalmic use should be clearly understood by both clinicians and patients alike.

Topics: Administration, Ophthalmic; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Eyelid Diseases; Female; Glaucoma; Humans; Lipodystrophy; Male; Middle Aged; Ophthalmic Solutions

To confirm the possible mechanism by which topical prostaglandin antiglaucoma drugs cause a deep superior sulcus.. Among patients who used bimatoprost (Lumigan), latanoprost (Xalatan), or travoprost (Travatan) and who developed a deep upper lid sulcus, 18 eyes of 11 patients (mean age, 58.2 ± 8.9 years) were studied. Seven patients were binocular users of one of the eye drops and four were monocular users. Preaponeurotic orbital fat was obtained, and the mean adipocyte density compared.. In the four monocular users, mean adipocyte density of treated eyes was 1758.21 ± 158.15 cells/mm(2), and that of untreated eyes was 1258.73 ± 127.54 cells/mm(2). This difference was statistically significant (P = 0.04), suggesting that the adipocytes were atrophied in the treated eyes. The mean adipocyte density of the bimatoprost group was 2073.35 ± 184.89 cells/mm(2), that of the travoprost group was 1623.46 ± 218.99 cells/mm(2), and that of the latanoprost group was 1468.20 ± 113.44 cells/mm(2). The densities of the bimatoprost and travoprost groups, but not of the latanoprost group (P = 0.75), were significantly different from that of the untreated group (P < 0.001).. Fat atrophy can be considered a mechanism of upper eyelid sulcus deepening in patients using topical prostaglandin analogs.

Topics: Adipocytes; Adipose Tissue; Amides; Antihypertensive Agents; Atrophy; Bimatoprost; Cell Count; Cloprostenol; Eyelid Diseases; Female; Glaucoma; Humans; Latanoprost; Male; Middle Aged; Ocular Hypertension; Orbital Diseases; Prostaglandins F, Synthetic; Travoprost

The IOP lowering effects of NCX 139, a new chemical entity comprising latanoprost amide and a NO-donating moiety, were compared to those of the respective des-nitro analog in in vitro assays and in rabbit and dog models of ocular hypertension. The NO donor, molsidomine as well as the prostamide bimatoprost (Lumigan(®)) and the prostaglandin agonist, latanoprost (Xalatan(®)) were also investigated for comparison. NCX 139 but not its des-nitro analog resulted in NO-mediated vascular relaxant effect in pre-contracted rabbit aortic rings (EC(50)=0.70±0.06 μM; E(max)=80.6±2.9%). Like bimatoprost (IC(50)=3.07±1.3 μM) or latanoprost (IC(50)=0.48±0.15 μM), NCX 139 displaced (3)H-PGF2α binding on recombinant human prostaglandin-F (FP) receptors with an estimated potency of 0.77±0.13 μM. In transient ocular hypertensive rabbits, bimatoprost and latanoprost were not effective while molsidomine elicited a dose-dependent reduction of IOP confirming the responsiveness of rabbits to NO but not to FP receptor agonists. NCX 139 tested at a therapeutically relevant dose, significantly lowered IOP while the des-nitro analog was not effective (0.03% NCX 139, Δ(max)=-12.8±2.0 mmHg). In glaucomatous dogs, 0.03% NCX 139 decreased IOP to a greater extent compared to an equimolar dose of the respective des-nitro derivative (Δ(max)=-4.6±1.0 and -2.7±1.3 mmHg, respectively for NCX 139 and its des-nitro analog). Albeit with low potency, NCX 139 also resulted effective in normotensive dogs while it did not reduce IOP in normotensive rabbits. NCX 139, a compound targeting two different and important mechanisms, is endowed with ocular hypotensive effects more evident in hypertensive conditions which may be of interest in the search of more effective treatments for hypertensive glaucoma.

Topics: Amides; Animals; Antihypertensive Agents; Aorta; Bimatoprost; Chromatography, High Pressure Liquid; Cloprostenol; Dinoprost; Disease Models, Animal; Dogs; Glaucoma; Intraocular Pressure; Latanoprost; Male; Molsidomine; Nitrates; Nitric Oxide; Nitric Oxide Donors; Ocular Hypertension; Prostaglandins F, Synthetic; Rabbits; Tandem Mass Spectrometry; Tonometry, Ocular; Vasodilation; Vasodilator Agents

Sturge-Weber syndrome (SWS) belongs to a group of disorders known as the phakomatoses. It is characterized by congenital hamartomatous malformations involving the eye, skin, and central nervous system. Several ocular complications are associated with SWS, including glaucoma.. A 66-year-old black man presented with a history of SWS and previously diagnosed glaucoma.. Clinicians need to be aware of cutaneous, neurologic, and ocular complications of this condition. However, glaucoma is the most common ocular complication of SWS.

Topics: Aged; Antihypertensive Agents; Cloprostenol; Glaucoma; Humans; Intraocular Pressure; Male; Optic Nerve; Sturge-Weber Syndrome; Travoprost; Treatment Outcome; Visual Acuity

Topics: Antihypertensive Agents; Cloprostenol; Drug Monitoring; Female; Glaucoma; Humans; Male; Medication Adherence

We investigated the potential cytotoxicity of various topical ophthalmic glaucoma formulations containing different preservatives in cultured human trabecular meshwork (TM) and non-pigmented ciliary epithelial (NPCE) cell lines.. We tested 0.004% travoprost preserved with either 0.015% benzalkonium chloride (BAK), sofZia or 0.001% Polyquad (PQ); and 0.005% latanoprost preserved with 0.020% BAK. We also tested a range of BAK concentrations in balanced salt solution (BSS). TM cells were treated for 10 min at 37°C with solutions diluted 1:10 to mimic the reduced penetration of topical preparations to the anterior chamber. Viability was determined by the uptake of the fluorescent vital dye calcein-AM (n = 6).. BAK solutions (diluted 1:10) demonstrated a dose-dependent reduction in cell viability in both cell types (TM and NPCE). With a 1:10 dilution of 0.020% BAK, there were significantly more living NPCE cells (89 ± 6%) than TM cells (57 ± 6%; p < 0.001). In TM cells, travoprost + BAK had statistically fewer live cells (83 ± 5%) than both travoprost + sofZia (97 ± 5%) and travoprost + PQ (97 ± 6%; p < 0.05). Compared with BSS-treated NPCE cells, travoprost had statistically fewer live cells (p < 0.05) when preserved with BAK (85 ± 16%), sofZia (91 ± 6%) or PQ (94 ± 2%).. These results demonstrate that substitution of BAK from topical ophthalmic drugs results in greater viability of cultured TM cells, the cells involved in the conventional outflow pathway. Cultured NPCE, responsible for aqueous inflow, appear more resilient to BAK.

Topics: Antihypertensive Agents; Benzalkonium Compounds; Cell Survival; Cells, Cultured; Ciliary Body; Cloprostenol; Dose-Response Relationship, Drug; Epithelial Cells; Glaucoma; Humans; Latanoprost; Polymers; Preservatives, Pharmaceutical; Prostaglandins F, Synthetic; Trabecular Meshwork; Travoprost

The combination of anti-glaucoma eye drops is frequently used in clinical treatment, and it is known that the combination can cause corneal damage. Recently, an anti-glaucoma combination eye drops is developed, and the treatment by the combination eye drops is expected to enhance quality of life. However, effects of the combination eye drops on corneal epithelial cell damage have not been clarified. In this study, we investigated the corneal epithelial cell damage of commercially available anti-glaucoma combination eye drops, such as Xalacom® (latanoprost/timolol maleate combination eye drops), Duotrav® (travoprost/timolol maleate combination eye drops) and Cosopt® (dorzolamide hydrochloride/timolol maleate combination eye drops) using the human corneal epithelial cell (HCE-T). The cytotoxicity in Xalacom® was higher than that in Xalatan® (eye drops containing latanoprost) and Timoptol® (eye drops containing timolol maleate), and the benzalkonium chloride (BAC) and timolol maleate were related to cytotoxicity in Xalacom®. The cytotoxicity in Duotrav® and Cosopt® was lower than that in Timoptol®. The Duotrav® is preserved with a non-BAC system (POLYQUAD, polidronium chloride). Therefore, it was suggested that the POLYQUAD related to the low cytotoxicity in Duotrav®. On the other hand, the D-mannitol reduced the cytotoxicity by BAC in this study. This result suggested that the cytotoxicity in Cosopt® was reduced by D-mannitol. The Duotrav® and Cosopt® may be less damaging to the ocular surface of glaucoma patients receiving long-term eye drop therapy in compared with the combination of anti-glaucoma eye drops.

Topics: Antihypertensive Agents; Cells, Cultured; Cloprostenol; Cornea; Drug Combinations; Epithelial Cells; Glaucoma; Humans; In Vitro Techniques; Latanoprost; Mannitol; Ophthalmic Solutions; Polymers; Preservatives, Pharmaceutical; Prostaglandins F, Synthetic; Sulfonamides; Thiophenes; Timolol; Travoprost

To characterize the effects of circadian rhythm, feeding time, age, general anesthesia, and ocular hypotensive compounds on intraocular pressure (IOP) of the Tibetan monkey (Macaca thibetana).. Tibetan monkeys were trained for IOP measurement with the TonoVet® rebound tonometer without sedation or anesthesia. Their circadian IOP fluctuation was monitored every 3 h. Effects of changing the feeding time, general anesthesia, age (2-3 year-old versus 8-15 year-old animals), and various pharmacological agents, such as travoprost, timolol, naphazoline and spiradoline, on IOP were also evaluated.. After behavioral training, conscious Tibetan monkeys were receptive to IOP measurement. The lowest and highest IOP values in a circadian cycle were recorded at 3:00 AM (19.8±0.4 mmHg, mean±SEM, n=12) and noon (29.3±0.9 mmHg), respectively. Changing the feeding time from 11:30 AM to 12:30 PM lowered the noon IOP to 25.1±1.2 mmHg. General anesthesia lowered IOP in these monkeys, while IOP of young and mature animals were similar. Three hours after topical ocular administration, travoprost reduced IOP by 5.2±0.6 mmHg (n=6, p<0.001), and timolol reduced IOP by 2.8±0.7 mmHg (p<0.05). Naphazoline and spiradoline lowered IOP by 4.8 mmHg and 2.5 mmHg (both p<0.001), respectively, 2 h after drug administration.. The circadian IOP fluctuation in conscious Tibetan monkeys and their responses to travoprost, timolol, and other experimental conditions are similar to other primates. These monkeys appear to be a suitable model for glaucoma research.

Topics: Animals; Antihypertensive Agents; Circadian Rhythm; Cloprostenol; Eye; Glaucoma; Intraocular Pressure; Macaca; Male; Models, Animal; Naphazoline; Pyrrolidines; Timolol; Tonometry, Ocular; Travoprost

We investigated the potential short and long-term effects in cultured human trabecular meshwork (TM) cells of various topical glaucoma formulations containing different preservatives.. We tested the fixed combination medications 0.004% travoprost plus 0.5% timolol preserved with either 0.015% benzalkonium chloride (BAK; DuoTrav®), or with 0.001% polyquad (PQ; DuoTrav(®) BAK-free); and 0.005% latanoprost plus 0.5% timolol preserved with 0.020% BAK (Xalacom(®)). Also tested was a range of BAK concentrations (0.001%-0.020%) in balanced salt solution (BSS). Cells were treated for 25 min at 37 °C with solutions diluted 1:10 and 1:100 to mimic the reduced penetration of topical preparations to the anterior chamber. The percentage of live cells was determined immediately after treatment through the uptake of the fluorescent vital dye calcein-AM. To determine any long-term effects, we assayed release of matrix metalloproteinase 9 (MMP-9) and apoptosis 24 h after treatments.. BAK demonstrated a dose-dependent reduction in TM cell viability, ranging from 71±5% live cells at 0.001% BAK (diluted 1:10) to 33±3% live cells at 0.020% BAK (diluted 1:10). Travoprost (0.004%) plus 0.5% timolol preserved with 0.015% BAK had statistically fewer live TM cells (79±7%) than the same preparation preserved with 0.001% polyquad® (PQ; 93±1%; p<0.001). Latanoprost plus timolol preserved with 0.020% BAK (29±9% live cells) was similar to the 0.020% BAK (33±3%) treatment. However, travoprost plus timolol preserved in 0.015% BAK had significantly more live cells (83±12%) than the 1:10 dilution of 0.015% BAK (49±10%). We also found 0.020% BAK (diluted 1:100) resulted in elevated levels of extracellular MMP-9 at 24 h.. These results demonstrate that the substitution of the preservative BAK from topical ophthalmic drugs results in greater in vitro viability of TM cells. Travoprost with timolol, but not latanoprost with timolol, countered some of the toxic BAK effects. BAK treatment appeared to cause elevated levels of MMP-9, a matrix metalloproteinase implicated in the pathogenesis of glaucoma.

Topics: Antihypertensive Agents; Apoptosis; Benzalkonium Compounds; Cell Survival; Cells, Cultured; Cloprostenol; Drug Combinations; Fluoresceins; Glaucoma; Humans; Latanoprost; Matrix Metalloproteinase 9; Polymers; Preservatives, Pharmaceutical; Prostaglandins F, Synthetic; Timolol; Trabecular Meshwork; Travoprost

Glaucoma is one of the leading causes of blindness and visual disability. Few studies have examined persistence and adherence with topical medications in glaucoma patients.. The objective of this study was to compare patient persistence with prostaglandin agonist (PA) monotherapy versus with concomitant adjunctive therapy (AT) in Canada.. Data were obtained from the Québec prescription claims database. Persistence rates were determined for previously treated naive glaucoma patients at 1 year after their index date for use of any of the three available PAs (bimatoprost, latanoprost, and travoprost). Patients who had at least 334 days on their index PA were defined as being persistent during the analysis timeframe. Patient baseline demographics and persistence rates were reported. A logistic regression was used for comparing the PA and PA + AT groups, which incorporated baseline cofounders, such as age and sex, in the analyses.. From an initial cohort of 28 534 patients, 14 893 were identified as naive to glaucoma therapy and had a PA as their index therapy. Of these, 11 197 (75.2%) continued to receive monotherapy and 3696 (24.8%) had an AT added to the PA; 59.0% were females, and the average age was 70.5 ± 11.3 years. Overall, at the end of the first year of therapy, 57.4% of patients were persistent on their index PA; however, a statistically significant difference was observed between the two subgroups, with 54.6% for those receiving PA monotherapy and 65.8% for those receiving PA + AT (p < 0.01) persistent with therapy. On average, 10.5 prescriptions per year were dispensed to persistent patients.. In this Canadian population, persistence rates fall to approximately 60% at the end of the first year of therapy, with patients taking AT being more persistent. Similar persistence analyses are warranted on other populations, and would yield helpful data for conducting economic evaluations of non-persistence.

Topics: Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Canada; Chemotherapy, Adjuvant; Cloprostenol; Databases, Factual; Female; Glaucoma; Humans; Insurance; Latanoprost; Logistic Models; Male; Medication Adherence; Middle Aged; Prostaglandin Antagonists; Prostaglandins F, Synthetic; Quebec; Travoprost

The purpose of this study was to report a case hypersensitive to topical bimatoprost and dexamethasone, but with no responsiveness to both latanoprost and travoprost.. A 41-year-old Chinese female presented with unilateral glaucoma secondary to iridocyclitis and long-term use of topical steroid. Trabeculectomy only worked for 9 months and then additional topical glaucoma medications were required to control the intraocular pressure (IOP). All commonly used IOP-lowering medications failed, except for bimatoprost, which significantly lowered the IOP. Topical dexamethasone increased IOP and caused ocular hypertension. Ultrasound biomicroscopy (UBM) was used to evaluate the anterior segment of the affected eye. Genomic DNA was extracted for sequence analysis of gene of prostaglandin F receptor (FP), E receptor 1 (EP1) and 2 (EP2) and myocilin.. UBM revealed cyclodialysis in the patient's affected eye after a single dosage of bimatoprost. The cyclodialysis resolved when IOP was elevated with the topical use of dexamethasone. The dexamethasone-induced high IOP could only be controlled by bimatoprost, whereas the bimatoprost-induced low IOP could only be elevated by topical dexamethasone. Allele C of rs3753380 and allele A of rs3766355 in FP gene and a -224T>C variation of myocilin gene were found in this patient. In addition, a novel heterozygous Cys346Tyr mutation was identified in EP2 gene. No sequence variation was found in EP1 gene.. The hypersensitivity of the affected eye to topical bimatoprost may be a result, at least in part, of cyclodialysis. The sequence analysis results suggested that, besides the polymorphism of FP gene, there might be some other mechanisms underlying the irresponsiveness of this patient to both latanoprost and travoprost. The mechanisms underlying the bimatoprost-induced cyclodialysis might correlate with its receptor selectivity. The -224T>C variation in the myocilin gene may affect the regulation of expression of this gene by dexamethasone.

Topics: Administration, Ophthalmic; Adult; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Dexamethasone; Female; Gene Expression Regulation; Glaucoma; Glucocorticoids; Humans; Intraocular Pressure; Latanoprost; Polymorphism, Genetic; Prostaglandins F, Synthetic; Receptors, Prostaglandin; Sequence Analysis; Travoprost

To evaluate "in vivo" the effect of topical travoprost on the central corneal thickness (CCT) of rabbit eyes, and the changes in the CCT after acute increases of intraocular pressure (IOP) in these eyes.. This is an interventional, prospective, case-control, masked study. Topical travoprost was applied once daily for one month to the right eye of six New Zealand male rabbits, the left eye of each animal served as control. The baseline CCT and IOP were measured under general anesthesia. After the IOP was stabilized at 15 and 30 mmHg, as registered by direct cannulation of the anterior chamber, CCT measurements were measured again at both pressure levels.. The baseline CCT was thicker in eyes previously treated with travoprost (study group) than in control eyes (p < 0.01). The CCT decreased in both groups when IOP was raised to 15 and 30 mmHg, and there were no statistically significant difference in absolute CCT values between study and control eyes at any of the IOP levels (p = 0.5). However, the amount of CCT decrease from baseline values was greater in eyes previously treated with travoprost (study group) than in control ones, at both 15 and 30 mmHg IOP levels (p = 0.01 and 0.02, respectively).. Rabbit corneas treated with topical travoprost show a different strain response to acute increases in IOP than control eyes.

Topics: Animals; Antihypertensive Agents; Cloprostenol; Cornea; Disease Models, Animal; Dose-Response Relationship, Drug; Follow-Up Studies; Glaucoma; Intraocular Pressure; Male; Ophthalmic Solutions; Prospective Studies; Rabbits; Tonometry, Ocular; Travoprost; Ultrasonography

Uninterrupted use of ocular hypotensive medication by glaucoma patients is important to prevent vision loss, but medication persistence is poor. Efficacy and tolerability influence physicians' decisions and patient persistence, and differences between medications may impact persistence.. To examine differences in physician's decisions to continue, switch, or discontinue therapy across three prostaglandin analogs (PGAs) latanoprost, bimatoprost, and travoprost using claims data supplemented by evaluation of physicians' charted therapeutic decisions.. A year of pharmacy claims data for 6271 patients with a first (index) fill between 5/1/2001 and 11/30/2004 for PGA monotherapy were classified as 'persistent', 'switched', 'restarted', or 'discontinued' with initial PGA use. An analysis of index therapy continuation during the first 2 years reflected chart reviews for 223 patients with PGA monotherapy as the index prescription.. Ten percent of patients had uninterrupted use of the initial PGA alone or in combination for a year. More than half (56%) stopped and then restarted, 16% switched, and 19% discontinued the initial PGA. Patients using latanoprost were more likely to be persistent (11%) compared to bimatoprost (9%) or travoprost (5%; p < 0.0001 overall comparison). Overall, 68% of patients on latanoprost persisted or restarted after a gap compared to 61% for bimatoprost and 58% for travoprost (p < 0.0001). Patient charts demonstrated a parallel pattern in physicians' decisions to continue latanoprost (56%), bimatoprost (45%), and travoprost (40%). Study limitations included the inability to establish causal links between variables, to account for sample use, or to document reasons for patient-driven changes in therapy. The study should be replicated in a more recent database including a larger population.. Uninterrupted use of ocular hypotensive therapy for a full year is relatively rare. Differences in physicians' decisions to continue, switch, or discontinue PGAs were observed in claims data, and parallel trends were observed in patient medical records.

Topics: Adult; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Continuity of Patient Care; Glaucoma; Humans; Latanoprost; Medication Adherence; Practice Patterns, Physicians'; Prostaglandins F, Synthetic; Retrospective Studies; Travoprost; United States

Prior research has demonstrated that medication persistence (continued acquisition of therapy over time) is far from optimal among patients with glaucoma. The purpose of the present study was to evaluate persistence with prostaglandin analogs among glaucoma patients in the first therapy year using a modification of a previously published technique.. This retrospective analysis of medical and pharmacy claims database included treatment-naive patients dispensed bimatoprost, latanoprost, or travoprost between 1/1/04-12/31/04. "Index agent" was defined as the first agent filled; "index date" was defined as the fill date. Follow-up continued for 358 days. Persistence measures for first therapy year were: (1) whether last fill had sufficient days supply to achieve medication possession at year's end, and (2) number of days for which the index agent was available (days covered). Associations between index agent and medication possession (logistic regression) and days covered (linear regression) were evaluated. Models were adjusted for gender, age, and previous ocular hypertension diagnosis.. 7873 patients met inclusion criteria (bimatoprost, n = 1464; latanoprost, n = 4994; travoprost, n = 1415). Medication possession was 28% and days covered was 131 when using the unadjusted (pharmacy-reported) days supply estimates and rose to 47-48% and days covered to 228-236 days when days supply was imputed. Compared to latanoprost, odds of achieving medication possession at first year's end were 26-34% lower for bimatoprost and 34-36% lower for travoprost (p

Topics: Adult; Aged; Amides; Bimatoprost; Cloprostenol; Databases, Factual; Drug Administration Schedule; Female; Follow-Up Studies; Glaucoma; Humans; Latanoprost; Linear Models; Male; Medication Adherence; Middle Aged; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Retrospective Studies; Travoprost

To identify patterns and rates of adherence with travoprost eye drops using the Travatan dosing aid (TDA) and to present a method for graphically presenting adherence data.. A prospective observational cohort study of patients on travoprost (prostaglandin) monotherapy. Patients were dispensed a TDA and followed up after approximately 3 months of usage. Data were downloaded from the TDA into a computer for analysis. Analysis used inter-dose intervals (the time between each dosing) to look at adherence between days 4 and 75.. In all, 100 patients were invited to participate, 53 agreed and complete TDA data sets were obtained from 37. In total 23 of the complete data sets showed good adherence (dosing within +/-4 h of the agreed dosing time on >80% of occasions), 3 patients discontinued usage before 75 days, 4 showed frequent drug holidays (no dosing for > or =8 days) and 7 frequently missed doses with adherence rates of <60%. Of the 16 patients for whom no TDA data was obtained, 5 were lost to follow-up, 4 had faulty/damaged TDAs, 3 changed medication, 3 preferred not to use the TDA, and 1 was hospitalized.. There were four easily defined patterns of adherence; (1) good adherence; (2) discontinued usage; (3) frequent drug holidays; and (4) frequent missed doses with low adherence rates. A new method for graphically presenting adherence data helps clinicians identify the pattern of usage and is a valuable aid to the overall management of patients on travoprost therapy.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Cloprostenol; Cohort Studies; Drug Monitoring; Female; Glaucoma; Humans; Male; Medication Adherence; Middle Aged; Ophthalmic Solutions; Prospective Studies; Travoprost

Topics: Administration, Topical; Antihypertensive Agents; Cloprostenol; Eyelashes; Female; Glaucoma; Humans; Ophthalmic Solutions; Travoprost

INTRODUCTION|: To investigate potentially adverse effects of different topical glaucoma medications and preservatives on cultured ocular epithelial cells. METHODS|: Confluent cultures of human corneal (10.014 pRSV-T) and conjunctival cells (1-5c-4) were assayed with 100 μL of different glaucoma medications for 25 minutes at 37°C and 5% CO₂. We also tested the preservative sofZia® (Alcon Laboratories, Fort Worth, TX, USA), as well as a range of concentrations of the preservative benzalkonium chloride (BAK; 0.001% to 0.050%). Balanced salt solution was used as the "live" control and a solution containing 70% methanol and 0.2% saponin was used as a "dead" control. The LIVE/DEAD viability/cytotoxicity kit (Invitrogen, Carlsbad, CA, USA) was used to determine the percentage of dead and live cells via ethidium homodimer and calcein fluorescence, respectively. RESULTS|: The toxicity of the prostaglandin analogs latanoprost, tafluprost and travoprost preserved with BAK was similar to the toxicity observed in their respective BAK concentrations. The prostaglandin analog travoprost (0.004%) preserved with the oxidizing preservative sofZia had much greater corneal and conjunctival cell survival than travoprost preserved with BAK. Travoprost (0.004%) containing polyquad also performed statistically better than its BAK-preserved formulation. CONCLUSION|: Ocular surface side effects have previously been demonstrated with chronic, long-term exposure to intraocular pressure-lowering medications containing the common preservative BAK. BAK alone has significant in-vitro cytotoxicity to cultured ocular epithelial cells. Substitution of BAK with polyquad or sofZia resulted in significantly higher percentages of live conjunctival and corneal cells. Further studies are needed to understand the- clinical implications of these findings.

Topics: Administration, Topical; Antihypertensive Agents; Benzalkonium Compounds; Cell Survival; Cells, Cultured; Cloprostenol; Conjunctiva; Dose-Response Relationship, Drug; Epithelium, Corneal; Glaucoma; Humans; Latanoprost; Ophthalmic Solutions; Polymers; Preservatives, Pharmaceutical; Prostaglandins F; Prostaglandins F, Synthetic; Travoprost

The aim of this study was to evaluate the change in hyperemia and intraocular pressure (IOP) in patients who switch from prostaglandin or prostamide to a fixed combination of prostamide and timolol maleate.. A multicenter, longitudinal, noncontrolled, nonrandomized open trial was conducted.. One hundred forty-four patients (282 eyes) were selected: 60 (41.6%) were on travaprost, 51 (35.4%) on bimatoprost, and 33 (22.9%) on latanoprost. All patients included were unable to attain adequate IOP control with monotherapy and had no contraindications to β-blockers.. Patients were treated with a fixed combination of bimatoprost and timolol maleate. Hyperemia was evaluated using a referential table, and IOP was measured at 8:00, 12:00, and 16:00 h both before and after 4 months of treatment.. IOP and hyperemia were compared at 2 time points: pretreatment and after 4 months. The mean of the 3 IOP measurements taken at various points during the day was considered for analysis. Generalized estimating equations were used for repeated measures and intereye dependency adjustments.. Hyperemia and IOP were reduced in all 3 groups, with the same pattern for both eyes. The bimatoprost group had the highest levels of hyperemia before treatment when compared with the latanoprost as well as the travaprost group and had the greatest reduction in hyperemia after treatment (P < 0.01). Regarding IOP, all 3 groups had a significant reduction (P < 0.001), but the bimatoprost group had a lower pretreatment IOP when compared with the travaprost and latanoprost groups.. A significant reduction in hyperemia was found after switching from monotherapy with prostaglandins or prostamide to a fixed combination of prostamide and a β-blocker. IOP reduction was significant after the intervention in all 3 groups.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Combinations; Follow-Up Studies; Glaucoma; Humans; Hyperemia; Intraocular Pressure; Latanoprost; Longitudinal Studies; Prostaglandins F, Synthetic; Time Factors; Timolol; Travoprost

Prostaglandin F2 alpha (PGF2a) analogues including bimatoprost and travoprost are used worldwide, often as first line topical treatments for glaucoma. We present 2 cases of a newly described side effect of both these topical agents in terms of periorbital fat atrophy. This visually noticeable side effect had features demonstrable on MRI scanning. The periorbital fat atrophy is most apparent with uniocular use and both doctors and patients need to be aware of this side effect before commencing treatment. The effects, however, appear to be reversible with treatment cessation.

Topics: Adipose Tissue; Administration, Topical; Aged, 80 and over; Amides; Atrophy; Bimatoprost; Cloprostenol; Female; Follow-Up Studies; Glaucoma; Humans; Magnetic Resonance Imaging; Male; Middle Aged; Orbital Diseases; Prostaglandins, Synthetic; Travoprost

The purpose of this study is to evaluate the intraocular pressure (IOP) -lowering effect and safety of topical travoprost with sofzia and without benzalkonium chloride on Japanese patients with glaucoma. Topical travoprost (0.04%) was used on 39 glaucoma patients with no prior use of topical prostaglandin F2alpha analogues (Beginning group). The IOP, number of conjunctival follicules, degrees of conjunctival hyperemia, and degrees of superficial punctate keratitis (SPK, AD-classification) were determined at the beginning of the treatment and after 1 month and 3 months. 37 other patients who were using 0.005% topical latanoprost were switched to 0.04% topical travoprost and analyzed in the same way (Switched group). For the Beginning group, the IOP was significantly decreased after 3 months (p < 0.0001). The conjunctival follicule score was decreased significantly (p = 0.033). Both the SPK area score and density score for the cases with SPK at the baseline decreased significantly (p = 0.034 and p = 0.024). In the switched group, the IOP was not changed significantly at 3 months after the switch (p = 0.118). Both the conjunctival follicule and hyperemia score were significantly decreased at 3 month (p = 0.0074 and p = 0.0047). The SPK area score for the cases with SPK at the time of switch decreased significantly (p = 0.013). Travoprost with sofzia preservative had an equal effect in reducing the IOP as latanoprost. It had low toxicity on the ocular surface of Japanese glaucoma patients.

Topics: Administration, Topical; Antihypertensive Agents; Benzalkonium Compounds; Cloprostenol; Glaucoma; Humans; Intraocular Pressure; Japan; Keratitis; Preservatives, Pharmaceutical; Prospective Studies; Travoprost

To investigate the relationship between industry- vs nonindustry-funded publications comparing the efficacy of topical prostaglandin analogs by evaluating the correspondence between the statistical significance of the publication's main outcome measure and its abstract conclusions.. Retrospective, observational cohort study.. English publications comparing the ocular hypotensive efficacy between any or all of latanoprost, travoprost, and bimatoprost were searched from the MEDLINE database. Each article was reviewed by three independent observers and was evaluated for source of funding, study quality, statistically significant main outcome measure, correspondence between results of main outcome measure and abstract conclusion, number of intraocular pressure outcomes compared, and journal impact factor. Funding was determined by published disclosure or, in cases of no documented disclosure, the corresponding author was contacted directly to confirm industry funding. Discrepancies were resolved by consensus. The main outcome measure was correspondence between abstract conclusion and reported statistical significance of the publications' main outcome measure.. Thirty-nine publications were included, of which 29 were industry funded and 10 were nonindustry funded. The published abstract conclusion was not consistent with the results of the main outcome measure in 18 (62%) of 29 of the industry-funded studies compared with zero (0%) of 10 of the nonindustry-funded studies (P = .0006). Twenty-six (90%) of the industry-funded studies had proindustry abstract conclusions.. Twenty-four percent of the industry-funded publications had a statistically significant main outcome measure; however, 90% of the industry-funded studies had proindustry abstract conclusions. Both readers and reviewers should scrutinize publications carefully to ensure that data support the authors' conclusions.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Clinical Trials as Topic; Cloprostenol; Conflict of Interest; Drug Industry; Glaucoma; Humans; Intraocular Pressure; Journal Impact Factor; Latanoprost; Periodicals as Topic; Prostaglandins F, Synthetic; Publication Bias; Research Support as Topic; Retrospective Studies; Travoprost

This study aimed to compare the cost effectiveness of travoprost versus a fixed combination of latanoprost/timolol as first-line therapies for ocular hypertension or glaucoma.. Patient charts were extracted from the UK General Practitioner Research Database. Patients with ocular hypertension or glaucoma who received first-line treatment with either travoprost or latanoprost/timolol and were followed up for >6 months were included. Treatment failure was defined as a treatment change or a glaucoma intervention (laser therapy or surgery). Time to treatment failure was compared using a Cox model and adjusted by the propensity score method.. Eligible patients received either travoprost (n=639) or latanoprost/timolol (n=176). Their mean age was 70 years at diagnosis and 48.2% of patients were male. Patient characteristics did not differ significantly between treatment groups. Treatment failure rates at 1 year were 31.3% (travoprost) and 39.4% (latanoprost/timolol) and yielded a hazard ratio for failure in favour of travoprost (0.75; p<0.04) after adjusting for age, sex, co-morbidities and duration of follow-up. Adjusted annual costs of glaucoma management were significantly (p<0.001) less with travoprost (pound215.86) than with latanoprost/timolol (pound327.83).. In everyday practice, travoprost was maintained longer than latanoprost/timolol as first-line therapy for glaucoma. The mean daily costs of travoprost were 50.8% less per patient than those of latanoprost/timolol. Despite adjustments, these results might be confounded, at least partially, by disease severity.

Topics: Aged; Antihypertensive Agents; Cloprostenol; Cost-Benefit Analysis; Databases, Factual; Drug Combinations; Female; Glaucoma; Humans; Latanoprost; Male; Ocular Hypertension; Ophthalmic Solutions; Physicians, Family; Prostaglandins F, Synthetic; Timolol; Travoprost; United Kingdom

Because of the limited ability to perform controlled, randomized studies in children, the safety and effectiveness of topical medications in pediatric glaucoma is sometimes difficult to determine. Although travoprost has been commercially available since 2001, there are no published reports on its use in children. This retrospective study found travoprost to have minimal adverse events in children and to reduce IOP in select cases of pediatric glaucoma.

Topics: Adolescent; Antihypertensive Agents; Child; Child, Preschool; Cloprostenol; Female; Glaucoma; Humans; Infant; Intraocular Pressure; Male; Retrospective Studies; Travoprost; Treatment Outcome

To identify risk factors for poor adherence to topical once daily therapy for glaucoma.. Prospective, observational cohort study.. A total of 196 patients with glaucoma who were being treated with a prostaglandin analog in 1 or more eyes at the Scheie or Wilmer Eye Institutes between August 2006 and June 2007.. Demographics, ocular history, and responses to interview questions about glaucoma knowledge, health beliefs, and drop-taking behaviors were obtained from each patient. All patients used the Travatan Dosing Aid (DA; Alcon Laboratories Inc., Fort Worth, TX) to administer travoprost as prescribed. Devices were collected at 3 months, and the data of drop use were downloaded using software provided with the DA. Patients taking 75% of doses.. Risk factors for poor adherence.. Eighty-seven patients (44.4% of the 196 subjects with evaluable data at 3 months) used the DA on 75% or less of the monitored days. In univariate analysis, poorer adherers were more likely to be <50 or >or=80 years of age, to be African American, to report less than excellent health, to report higher amounts of depression, to have lower income, and to be treated at the Scheie Eye Institute. Multivariate analysis (adjusting for education and income) found that age, race/ethnicity, and less than excellent health were associated with poor adherence.. Those who failed to take more than 75% of eyedrop doses were more likely to be African American and to report poor health. Those in the youngest and oldest age groups were less adherent, although this finding was not always statistically significant. Further research into the factors driving these associations and into developing predictive models to assist in screening for low adherence are warranted.. Proprietary or commercial disclosure may be found after the references.

Topics: Age Factors; Aged; Aged, 80 and over; Antihypertensive Agents; Cloprostenol; Drug Monitoring; Ethnicity; Female; Follow-Up Studies; Glaucoma; Health Knowledge, Attitudes, Practice; Humans; Intraocular Pressure; Male; Medication Adherence; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prospective Studies; Risk Factors; Surveys and Questionnaires; Travoprost

Topics: Antihypertensive Agents; Cloprostenol; Drug Combinations; Glaucoma; Humans; Latanoprost; Ocular Hypotension; Prostaglandins F, Synthetic; Timolol; Travoprost; Treatment Failure

Experimental studies demonstrated an alteration of corneal collagen structure by prostaglandin analogues. The possible effect of the prostaglandin F(2alpha) analogue travoprost 0.004% on the central corneal thickness (CCT) in newly diagnosed glaucoma patients was evaluated.. Consecutive, interventional case series. Seventy-four patients/136 eyes with glaucoma were included in the statistical analysis. All patients received travoprost 0.004% (Travatan(R)) once daily in one or both eyes. CCT was measured by using noncontact optical low-coherence reflectometry prior to the treatment and after 6 and 12 months.. Mean CCT of all treated eyes (n = 136) was 546.71 +/- 34.63 mum at baseline, 535.14 +/- 34.78 mum after 6 months, and 532.38 +/- 34.18 mum after 12 months (ANOVA, P < 0.001). Ninety-five percent of all treated eyes showed a decrease of CCT. CCT reduction mainly developed within the first 6 months of the treatment period. After 12 months, a CCT reduction >30 mum occurred in 5.1% of all treated eyes. There was a significant correlation between the magnitude of corneal thinning and the initial CCT but not between corneal thinning and IOP reductions.. Topical therapy with the prostaglandin derivate travoprost is accompanied by a significant reduction of CCT within one year of treatment. Further clinical studies are needed to evaluate the possible long-term effects of prostaglandins on the CCT of glaucoma patients.

Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Cloprostenol; Cornea; Female; Glaucoma; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prospective Studies; Tomography, Optical Coherence; Tonometry, Ocular; Travoprost; Ultrasonography

To develop a model to estimate and compare the cost of changing therapy due to hyperemia in glaucoma patients treated initially either with latanoprost, bimatoprost, or travoprost monotherapy.. Data collected from the HealthCore Integrated Research Database, as part of the Glaucoma Adherence and Persistency Study (GAPS), were used to populate the model. Patients with a documented diagnosis of glaucoma who were newly treated (no ocular hypotensive medication and no glaucoma-related procedure during 6 months before first prescription) with latanoprost, bimatoprost, or travoprost monotherapy were identified. The time horizon for the base-case model was the duration of chart abstraction (mean = 4.1 years); a 3-month model also was developed. Physician-reported rates of hyperemia were obtained from chart reviews of 300 patients. Transition rates reflected events related to reports of hyperemia where a physician-driven change (switch or discontinuation) in therapy was documented. The per-patient direct cost (2008) due to hyperemia-driven change in therapy was calculated as the sum of the cost of the initial prescription plus the cost of the office visit where the patient was evaluated and the decision to change therapy was made. Costs were stratified by whether patients were hyperemia free or discontinued the initial therapy due to hyperemia.. From the sample of 13,977 newly treated patients, 8,743 patients were started on a prostaglandin monotherapy only. Of these, 5,726 received latanoprost, 1,633 were treated with bimatoprost, and 1,384 received travoprost index monotherapy. Across all treatment groups, costs among hyperemia-free patients were US$73.67 versus US$140.02 for those who discontinued the initial prostaglandin due to hyperemia. Per-patient costs were lowest in the group treated initially with latanoprost. For the base-case model, with latanoprost as the reference, total per-patient incremental costs due to hyperemia-driven change in therapy were US$5.92 for bimatoprost and US$5.43 for travoprost. Results were not highly sensitive to increases either in the incidence of hyperemia among latanoprost-treated patients or in the cost of latanoprost.. Hyperemia results in increased overall costs in patients treated with latanoprost, bimatoprost, and travoprost. Treatment with latanoprost is associated with lower hyperemia-related costs than treatment with bimatoprost or travoprost.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Costs and Cost Analysis; Databases, Factual; Drug Costs; Glaucoma; Humans; Hyperemia; Latanoprost; Models, Economic; Prostaglandins F, Synthetic; Retrospective Studies; Travoprost

With the launch of the fixed combination of travoprost 0.004%/timolol 0.5% (trav/tim) in Germany in May 2006, a noninterventional observational study designed as an open-label, multicenter, 6-week trial was initiated in order to evaluate the efficacy and tolerability of this new drug combination in glaucoma patients. Participants were grouped into categories according to previous drug regimens: those on timolol monotherapy; those on prostaglandin analog (PGA) monotherapy; those on concomitant therapy with a PGA and timolol; and those on fixed combinations. Trav/tim was well accepted by the patients, with 87.9% judging the tolerability of the therapy as good, very good, or excellent. Analysis of intraocular pressure (IOP) measurements showed statistically significant IOP decreases in all four categories examined in our study after regimen substitution with fixed-combination trav/tim. Fixed-combination prostaglandin analog/beta-blocker formulations are an attractive therapeutic option due to their strong IOP-lowering efficacy with once-daily dosing. In this study, glaucoma patients who underwent a regimen modification to fixed-combination trav/tim showed further reductions in IOP, irrespective of which selected monoor multiple therapies had been used previously.

Topics: Aged; Chemistry, Pharmaceutical; Cloprostenol; Drug Combinations; Female; Germany; Glaucoma; Humans; Male; Middle Aged; Timolol; Travoprost

Topics: Adrenergic beta-Antagonists; Aged; Antihypertensive Agents; Cloprostenol; Depressive Disorder; Drug Combinations; Glaucoma; Humans; Male; Ophthalmic Solutions; Timolol; Travoprost

Carotid cavernous sinus fistula is abnormal communications between the carotid arterial system and the venous cavernous sinus. Carotid cavernous sinus fistula can develop either because of trauma or spontaneous causes. Spontaneous carotid cavernous sinus fistula is often associated with a pre-existing aneurysm in the intracavernous portion of internal carotid artery. However, these fistulas may be congenital arteriovenous connections that open spontaneously in the settings of collagen vascular disease, atherosclerosis, hypertension, or may develop in females during peripartum period. A case of spontaneous carotid cavernous sinus fistula in a young adult male who presented with pulsating exophthalmos and secondary glaucoma is presented. Characteristic features of arteriovenous fistula--bruit, thrill, corkscrew episcleral vessels were present. Radiological investigations were done to confirm the diagnosis. Transvenous embolisation was done to close the fistula.

Topics: Adult; Amides; Antihypertensive Agents; Bimatoprost; Carotid-Cavernous Sinus Fistula; Cloprostenol; Exophthalmos; Glaucoma; Humans; Male; Timolol

To evaluate the rate of flares in patients with uveitic glaucoma treated with topical bimatoprost and to assess its effect on intraocular pressure (IOP) in this subset of patients.. Retrospective case series.. All patients seen at one subspecialty uveitis practice with history of uveitic glaucoma treated with topical bimatoprost were identified and the data collected, which included onset, type, duration of uveitis, onset of secondary glaucoma, and previous therapies for glaucoma. The time of onset of bimatoprost therapy, the IOP, and flare-up rate before and after initiation of treatment with bimatoprost were recorded at one week and one, three, and six months of follow-up.. Of the 42 patients (59 eyes) identified, 12 patients had used other topical lipid agents, which were replaced by bimatoprost. Twenty-three patients had not used any lipid agents and bimatoprost was added to their existing antiglaucoma regimen. Seven patients were newly diagnosed with uveitic glaucoma and were commenced with topical bimatoprost. The rate of uveitis flares while on other antiglaucoma therapy was 52 per 100 person-years follow-up, while on bimatoprost therapy it was 32.4 per 100 person-years follow-up (P = .206). The mean IOP prior to bimatoprost therapy was 27 +/- 13.2 mm Hg and after initiation of topical bimatoprost was 15 +/- 5.5 mm Hg at the end of six months (P = .0008).. These data suggest that bimatoprost is an effective IOP-lowering agent in patients with uveitic glaucoma in whom the uveitis is controlled on immunomodulatory therapy, and it does not increase the rate of flares of uveitis in these patients.

Topics: Administration, Topical; Adolescent; Adult; Aged; Aged, 80 and over; Amides; Anterior Chamber; Antihypertensive Agents; Bimatoprost; Child; Cloprostenol; Female; Glaucoma; Humans; Immunologic Factors; Intraocular Pressure; Male; Middle Aged; Recurrence; Retrospective Studies; Time Factors; Tonometry, Ocular; Uveitis; Young Adult

Control of intraocular pressure (IOP) is a major factor in avoiding visual impairment related to glaucoma. Both the cost and the effectiveness of therapy should be considered when initiating this lifelong treatment. The aim of this study was to assess the cost effectiveness of travoprost versus latanoprost as single agents for the treatment of glaucoma in France.. Two surveys, one documenting efficacy and the other costs, were used to provide data for a Markov model. The model reproduced the 5-year course of patients receiving a prostaglandin analogue, travoprost or latanoprost, as monotherapy. The effectiveness criterion was fitted with a Weibull distribution from a national study. Transition probabilities and costs per treatment line were extracted from two French observational databases. Bootstrap techniques were implemented to drive the probabilistic sensitivity analyses. The study compared both treatments given once daily as monotherapy to ambulatory patients with primary open-angle glaucoma or ocular hypertension. The main outcome measure was mean time to treatment change (MTTC). Possible treatment changes were the addition of adjunctive medication, treatment substitution, laser therapy or surgery. After laser therapy or surgery, patients could continue with no treatment or proceed to prostaglandin analogue as monotherapy or treatment substitution. IOP was stratified at treatment onset as < or =20, 21-23 and > or =24 mmHg, respectively. All costs were expressed in 2005 euros.. MTTC was 44.3 months for travoprost and 37.8 for latanoprost. Additional 5-year costs for travoprost were euro51, resulting in an incremental cost-effectiveness ratio without treatment change of euro95 per year. Of patients treated with latanoprost, 1.9% underwent laser therapy or surgery, compared with 1.2% of patients treated with travoprost. The results differed with baseline IOP values, such that 55.6%, 53.9% and 50.4% of patients with pretreatment IOP values of < or =20, 21-23 and > or =24 mmHg, respectively, continued to receive travoprost treatment at 5 years, compared with 32.3%, 26.1% and 26.1% of patients, respectively, receiving latanoprost. Thus, incremental cost-effectiveness ratios (ICERs) without treatment change were euro140, euro45 and euro123 per year, respectively.. Travoprost demonstrated a longer effectiveness profile than latanoprost and minimized early treatment changes. The smaller proportion of patients needing a new treatment, laser therapy or surgery virtually compensated for the higher travoprost acquisition cost. Overall, travoprost is cost effective compared with latanoprost, and is most cost effective in patients with pretreatment IOPs between 21 and 23 mmHg.

Topics: Age Factors; Aged; Antihypertensive Agents; Cloprostenol; Cost-Benefit Analysis; Databases, Factual; Drug Costs; Feasibility Studies; Female; France; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Male; Markov Chains; Proportional Hazards Models; Prostaglandins F, Synthetic; Sex Factors; Survival Analysis; Time Factors; Travoprost; Treatment Outcome

Topics: Aged; Antihypertensive Agents; Choroid Diseases; Cloprostenol; Glaucoma; Humans; Intraocular Pressure; Male; Ocular Hypotension; Trabeculectomy; Travoprost

This study compared the toxicity profiles of three antiglaucoma prostaglandin F2alpha analogs, latanoprost, travoprost, and bimatoprost which contain benzalkonium chloride (BAK), with tafluprost, a new preservative-free prostaglandin analog.. IOBA-NHC cells were exposed to BAK-containing prostanoid solutions, their respective BAK concentrations, and preservative-free tafluprost solution for 30 min. Membrane integrity, apoptosis, oxidative stress, and cells morphology were evaluated.. Preservative-free tafluprost resulted in significantly higher membrane integrity and lower pro-apoptotic and pro-oxidative effects than preservative-containing prostaglandin analog preparations.. These results suggest that tafluprost, a new preservative-free prostaglandin analog, has very low or no pro-apoptotic, pro-necrotic, or pro-oxidative effects in vitro compared to preservative-containing formulations.

Topics: Amides; Apoptosis; Benzalkonium Compounds; Bimatoprost; Cell Line; Cell Membrane; Cell Survival; Cloprostenol; Conjunctiva; Dinoprost; DNA; Drug Combinations; Epithelial Cells; Glaucoma; Humans; Latanoprost; Ocular Hypertension; Preservatives, Pharmaceutical; Prostaglandins F; Prostaglandins F, Synthetic; Receptors, Purinergic P2; Receptors, Purinergic P2X7; Superoxides; Travoprost

The aim of this communication is to report enophthalmos as a possible new adverse effect of topical bimatoprost treatment.. A retrospective case series of five glaucoma patients under long-term topical bimatoprost treatment was evaluated. Documentation with photo and Hertel exophthalmometry was reviewed.. In all five patients a deep lid sulcus, reduced infraocular fat pads and enophthalmos-suspicious Hertel values were found (mean 11.9 mm; SD 2.4). Other aetiologies for enophthalmos were excluded anamnestically and by clinical examination.. Bimatoprost may lead to an alteration of the eyelid with deepening of the lid sulcus and may also be responsible for an iatrogenic orbital fat atrophy. A possible mechanism of action might be the induction of apoptosis of orbital fibroblasts with a remodelling of the extracellular matrix. Prospective studies are necessary to confirm this cross-sectional observation.

Topics: Adipose Tissue; Administration, Topical; Aged, 80 and over; Amides; Antihypertensive Agents; Atrophy; Bimatoprost; Cloprostenol; Enophthalmos; Eye; Female; Glaucoma; Humans; Male

To investigate the ocular surface inflammatory response to chronic topical treatments in patients with glaucoma by measuring the cytokine level in tears using multiplex bead analysis.. Tear samples were collected from 21 patients with glaucoma and 12 healthy volunteers. Tears were analysed for the presence of 17 cytokines: interleukin (IL)1beta, IL2, IL4, IL5, IL6, IL7, IL8, IL10, IL12, IL13, IL17, granulocyte-colony stimulating factor, granulocyte-macrophage stimulating factor, interferon (INF)gamma, monocyte chemotactic protein (MCP)1, macrophage inflammatory protein 1beta and tumour necrosis factor (TNF)alpha. The cytokines in each sample of tears were measured using multiplex bead analysis with microspheres as solid support for immunoassays.. In the tears of treated patients, proinflammatory cytokines (IL1beta, IL6, IL12, TNFalpha) were significantly increased compared with controls. T helper (Th)1 (INFgamma, IL2) and Th2 (IL5, IL10, IL4) type cytokines were also significantly higher (p<0.05); however, the most marked increase was observed with Th1 cytokines. The expression of chemokine IL8 and MCP1 was also increased in the treated group.. This study shows that pro-inflammatory cytokine secretion by conjunctival cells is increased in response to topical treatments for glaucoma. The characterisation of cytokines in tears was previously limited by the small volume attainable, a limitation that has been overcome by multiplex analysis.

Topics: Administration, Topical; Aged; Amides; Antihypertensive Agents; Bimatoprost; Brimonidine Tartrate; Carteolol; Case-Control Studies; Chemokines; Cloprostenol; Cytokines; Dose-Response Relationship, Immunologic; Drug Therapy, Combination; Female; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Lipids; Male; Prospective Studies; Prostaglandins F, Synthetic; Quinoxalines; Sulfonamides; Tears; Thiophenes; Timolol

To develop an alternative method for analysis of patient persistence with prescribed medications using the prostaglandin class of intraocular pressure (IOP)-lowering drugs as a model.. A retrospective study of prescription refill patterns.. Patients with a pharmacy claim for a 2.5 ml bottle of latanoprost, travoprost, or bimatoprost between September 1, 2002 and December 31, 2002 were identified from a retail pharmacy database and were followed up for 12 months. Three separate analyses defined gaps in therapy as spans in excess of 45, 60, or 120 days without a refill for the same medication. Patients were categorized by the number of gaps in therapy and the cumulative length of gaps. A Kaplan-Meier analysis was conducted using a 120-day allowable refill period.. For refill periods of 45, 60, and 120 days, 10.6%, 28.6%, and 77.5% of patients, respectively, had no gaps in therapy, and 32.6%, 53.4%, and 86.5%, respectively, had 30 days or fewer off therapy annually. According to the 45-day threshold analysis, 50.7% of patients had three or more gaps vs 18.5% in the 60-day analysis and none in the 120-day analysis. The Kaplan-Meier curve shows 88.6% and 76.1% of patients were persistent for 120 days and one year, respectively.. Compared with Kaplan-Meier survival curves, the gap analysis approach may better parallel clinical experience with patient persistence, in which patients stop and restart medications for a variety of reasons over time. This method also may help to identify avenues for investigation of lack of persistency among many patients.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Prescriptions; Drug Utilization; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Lipids; Patient Compliance; Pharmacies; Preferred Provider Organizations; Prostaglandins F, Synthetic; Retrospective Studies; Travoprost

With use of the Wong-Kilbourne derivative Chang conjunctival cell line, this study compared in vitro the ocular toxicity of three topical intraocular pressure (IOP)-lowering agents: travoprost 0.004% containing 0.015% benzalkonium chloride (BAK), travoprost Z 0.004%, a new formulation without BAK, and latanoprost 0.005% containing 0.02% BAK.. Neutral red, Alamar blue, YOPRO-1, and annexin V/7-AAD assays were used to evaluate the effects of the IOP-lowering agents and BAK on cellular viability, membrane integrity, and apoptosis in the conjunctival cell line using microtitration fluorometric analysis and flow cytometry. All assessments were performed in a masked manner.. Assessment of cell viability and membrane integrity revealed a significant effect by latanoprost with BAK or BAK alone but no effect by travoprost Z without BAK or buffer alone (P < 0.0001). Latanoprost with BAK, travoprost with BAK, and BAK alone were cytotoxic in Chang conjunctival cells, whereas no cytotoxicity was observed in cells exposed to travoprost Z without BAK or in cells treated with buffer (P < 0.0001). No increase in apoptosis or necrosis was observed in cells treated with control or travoprost Z without BAK compared with BAK, travoprost with BAK, and latanoprost with BAK (P < 0.0001).. Latanoprost with BAK, travoprost with BAK, and BAK alone have significant cytotoxic effects on human conjunctiva-derived cells and are associated with apoptosis. These effects likely result from BAK used as a preservative. IOP-lowering agents with alternative preservatives instead of BAK will most likely have fewer ocular surface adverse effects than agents containing BAK.

Topics: Annexin A5; Antihypertensive Agents; Apoptosis; Benzalkonium Compounds; Cell Line; Cell Membrane; Cell Survival; Cloprostenol; Conjunctiva; Drug Therapy, Combination; Flow Cytometry; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Necrosis; Preservatives, Pharmaceutical; Prostaglandins F, Synthetic; Travoprost

To determine monthly cost and cost effectiveness of bilateral prostaglandin/prostamide therapy for lowering intraocular pressure (IOP) in patients taking bimatoprost 0.03% (Lumigan, Allergan, Inc.), latanoprost 0.005% (Xalatan, Pfizer, Inc.), or travoprost 0.004% (Travatan, Alcon Laboratories, Inc.).. Drops in five new 2.5-mL bottles were counted and then averaged for each drug. Average retail price was determined by surveys of pharmacies. Drop count, average retail price, average wholesale price, and IOP reduction data were used to compute annual cost, and cost effectiveness (annual cost-per-mm Hg of IOP reduction) of the three drugs.. Drops per 2.5-mL bottle averaged 113 for bimatoprost 0.03%, 84 for latanoprost 0.005%, and 83 for travoprost 0.004%. Average retail cost (2005) per bottle was $69.99 for bimatoprost 0.03%, $61.69 for latanoprost 0.005%, and $66.37 for travoprost 0.004%. The monthly retail cost of bilateral therapy was $37.92 for bimatoprost 0.03%, $44.75 for latanoprost 0.005%, and $49.25 for travoprost 0.004%. Cost effectiveness ranges were $57 to $65 per mm Hg reduction in IOP per year for bimatoprost, 0.03%, $67 to $90 per mm Hg for latanoprost 0.005%, and $74 to $84 per mm Hg for travoprost 0.004%.. Bimatoprost 0.03% had the lowest monthly and annual costs and the greatest cost effectiveness for lowering IOP compared with latanoprost 0.005% and travoprost 0.004%.

Topics: Amides; Bimatoprost; Cloprostenol; Cost-Benefit Analysis; Drug Costs; Economics, Pharmaceutical; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Lipids; Ocular Hypertension; Prospective Studies; Prostaglandins F, Synthetic; Travoprost

To compare the effectiveness and associated costs of travoprost versus a fixed combination of dorzolamide + timolol as first-line therapy for glaucoma according to data collected by the United Kingdom General Practitioner Research Database (UK-GPRD).. Patients with a diagnosis of ocular hypertension, glaucoma, or who had been treated topically by surgery or laser therapy were selected. Patients starting first-line treatment with travoprost or a fixed dorzolamide + timolol combination were included. Times to treatment failure were compared with an adjusted Cox model.. Cost and treatment failure defined as a prescription change (adding or removing a topical treatment, or initiating laser therapy or surgery).. 56 612 patients were extracted from the database and 39 808 patients received at least one topical prescription for IOP-lowering (intraocular pressure) therapy. Of these, 639 were treated with travoprost and 387 with dorzolamide + timolol, as first-line therapies. No significant difference was found between patient characteristics. Patients were aged 70.0 years and 48.5% were male. At 1 year, treatment failure was experienced by 30.4% of patients receiving travoprost and 49.4% receiving dorzolamide + timolol (p < 0.001). The hazard ratio for failure was 0.79 (p < 0.03) less with travoprost, after adjusting on age, gender, comorbidities and duration of follow-up. Adjusted annual costs of glaucoma management were significantly (p < 0.001) lower with travoprost ( pound198.31) than with dorzolamide + timolol ( pound312.21).. This retrospective costs and consequences analysis study showed that travoprost is more efficient than dorzolamide + timolol as first-line therapy for glaucoma patients. Patients continued longer with first-line treatment when prescribed travoprost at a lower cost.

Topics: Aged; Antihypertensive Agents; Cloprostenol; Cost-Benefit Analysis; Databases, Factual; Drug Combinations; Drug Costs; Female; Glaucoma; Humans; Male; Physicians, Family; Sulfonamides; Thiophenes; Timolol; Travoprost; United Kingdom

Topics: Aged; Amides; Bimatoprost; Cloprostenol; Glaucoma; Humans; Hypertrichosis; Lipids; Male

Drugs in the lipid class of glaucoma medications, including bimatoprost, travoprost and latanoprost, are effective at lowering intraocular pressure. In addition to clinical efficacy, the budget impact of long-term therapy with each medication is important for patients, physicians and managed-care decision makers to differentiate between the products and make informed decisions regarding the choice of therapy. This study aimed to determine the average number of days between refills for latanoprost, travoprost and bimatoprost, and to estimate the potential effect of differences in refill rates on pharmacy budgets.. In this retrospective database analysis of pharmacy records, the dispensing patterns of patients with glaucoma lipid therapies were obtained. Patients with a pharmacy prescription for the 2.5 mL bottle of latanoprost, travoprost or bimatoprost between September 2002 and December 2002, and receiving continuous treatment defined as having at least one prescription for the same lipid agent and bottle size 1 year later between September 2003 and December 2003, were included in this study. The main outcome measures were mean number of days between refills, mean number of refills, cost per patient per year (based on the average wholesale price [AWP]), and annual refill cost differences between cohorts.. The mean number of days between refills was 46.74 days, 53.65 days and 51.98 days for latanoprost, travoprost and bimatoprost, respectively (p < 0.0001, ANOVA). The mean number of refills per year was 7.1, 6.2 and 6.4 for latanoprost, travoprost and bimatoprost, respectively. Based on this and the AWP, the average cost per patient per year was $US435.16 for latanoprost, $US385.58 for travoprost and $US397.44 for bimatoprost. The cost savings per year if the population of patients using latanoprost (n = 79,820) used bimatoprost or travoprost instead would be approximately $US3.0-$US3.9 million.. A statistically significant difference in mean days between refills was found among the three studied drugs. Latanoprost presented the highest annual cost followed by bimatoprost and travoprost.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Budgets; Child; Child, Preschool; Cloprostenol; Cost Savings; Cost-Benefit Analysis; Databases, Factual; Drug Costs; Female; Glaucoma; Humans; Infant; Intraocular Pressure; Latanoprost; Lipids; Male; Middle Aged; Pharmacies; Prostaglandins F, Synthetic; Retrospective Studies; Time Factors; Travoprost

To evaluate the accuracy of a prototype electronic device for recording eye drop usage.. Ten volunteers were randomly assigned to one of five usage patterns designed to mimic common patterns of use in glaucoma patients from 100% compliant to 50% compliant. All participants agreed to adhere to a pre-determined "dosing" schedule for 15 days using the monitoring/reminder device to instill artificial tears. Participants also recorded drop usage in a diary. The main outcome measures were device accuracy and reproducibility. Device accuracy was defined as the magnitude of the difference between the diary and device output for three variables: date, number of drops, and instillation time.. Date stamping by the device was 100% accurate. The mean +/- SD time difference between the device and the diary was -2.0 +/- 19.7 minutes when data from all participants was pooled. In seven of the ten participants, the device did not record at least one drop. The mean +/- SD difference in the number of drops recorded by the device minus the diary was 0.16 +/- 0.97 when data from all participants was pooled.. The prototype compliance reminder/monitoring device may underestimate compliance in some patients. The date and time stamping mechanisms were generally accurate and reproducible.

Topics: Antihypertensive Agents; Cloprostenol; Drug Utilization; Glaucoma; Humans; Monitoring, Ambulatory; Ophthalmic Solutions; Patient Compliance; Reproducibility of Results; Travoprost

Cost-effectiveness evaluation of monotherapy with the newer lipid class of intraocular pressure (IOP)-lowering medications in glaucoma and ocular hypertension.. Retrospective pharmacoeconomic analysis.. Analysis included all published studies measuring IOP reduction from untreated baseline with once-daily bimatoprost (Lumigan), latanoprost (Xalatan), or travoprost (Travatan) monotherapy in patients with elevated IOP. Percentage IOP reduction at the final study visit was calculated using the early morning IOP measurement to control for diurnal variation in IOP. Patient-weighted average percentage IOP reductions were computed for each medication. Cost per 2.5-ml bottle was determined using PriceAlert 2005 (February). Cost-effectiveness was defined as monthly cost of medication per patient-weighted average 1% reduction in IOP.. Studies included 951 bimatoprost, 1598 latanoprost, and 765 travoprost patients. The AWP in February, 2005 for a 2.5-ml bottle was 62.10 dollars for bimatoprost, 61.29 dollars for latanoprost, and 62.19 dollars for travoprost. Patient-weighted average IOP reduction was 32.4% for bimatoprost, 29.6% for latanoprost, and 29.0% for travoprost. Calculated cost-effectiveness was 1.92 dollars for bimatoprost, 2.07 dollars for latanoprost, and 2.14 dollars for travoprost. Incremental cost-effectiveness ratio (ICER) analysis showed an incremental cost of 0.29 dollars for each additional 1% IOP reduction provided by bimatoprost over latanoprost. The rank order of the cost-effectiveness of the drugs (bimatoprost > latanoprost > travoprost) was robust in sensitivity analyses to cost and efficacy.. On the basis of AWP and patient-weighted average percentage IOP reduction in published studies, bimatoprost had the most favorable cost-effectiveness among the drugs compared. Cost-effectiveness should be considered along with traditional clinical safety and efficacy measures to make individual and group healthcare decisions.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cost-Benefit Analysis; Drug Costs; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Lipids; Ocular Hypertension; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic; Travoprost

Although the probability of treatment success should be the primary factor guiding the choice of an intraocular pressure (IOP)-lowering medication, treatment cost is also important to physicians, patients and third-party payers. The objective of the present study was to compare the cost effectiveness of bimatoprost with that of latanoprost in the treatment of glaucoma and ocular hypertension.. Estimated yearly costs and cost per treatment success for bimatoprost ophthalmic solution 0.03% once daily (Lumigan), Allergan, Inc., Irvine, CA, USA) were compared with those for latanoprost ophthalmic solution 0.005% once daily (Xalatan), Pfizer, Inc., New York, NY, USA). The pharmacoeconomic model was based on medical resource costs and the percentage of patients achieving > or =20% decrease in IOP from baseline at 8:00 am, 12:00 pm and 4:00 pm after 6 months of treatment (clinical success rate). Calculations were also made using the average success rate throughout the day and the average success rate minus the percentage of patients who withdrew from treatment as a result of adverse events.. After 6 months of treatment, the clinical success rates were significantly higher with bimatoprost than with latanoprost (p < or = 0.003). The average expected yearly cost per patient was similar for bimatoprost (US1151 dollars) and latanoprost (US1193 dollars). The cost per treatment success, however, averaged US568 dollars less with bimatoprost (US1501 dollars/success) than with latanoprost (US2069 dollars/success). This was true even when the percentage of patients who withdrew from treatment as a result of adverse events was subtracted from the clinical success rate.. The greater efficacy of bimatoprost resulted in a lower cost per treatment success than was seen with latanoprost. This remained true even when responder rates were adjusted by subtracting the percentage of patients who withdrew from treatment as a result of adverse events.

Topics: Algorithms; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cost-Benefit Analysis; Drug Costs; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Lipids; Models, Statistical; Ocular Hypertension; Prostaglandins F, Synthetic; Treatment Outcome

Topics: Aged; Antihypertensive Agents; Cloprostenol; Female; Glaucoma; Humans; Intraocular Pressure; Travoprost; Uveitis, Anterior

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cost-Benefit Analysis; Decision Support Techniques; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Lipids; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic; Reproducibility of Results; Treatment Outcome

Prostaglandin-like drugs such as latanoprost (Xalatan), travoprost (Travatan) and bimatoprost (Lumigan) lower the intraocular pressure by improving the outflow of aqueous humor via the uveoscleral pathway. Up to now there is no report about a macular edema after the topical use of Lumigan eye drops in a pseudophakic patient with an intact posterior capsule.. A 69-year-old pseudophakic patient with a 14-year history of glaucoma in pseudoexfoliation syndrome, revealed a cystoid macular edema after local treatment with bimatoprost . 6 months earlier a phakoemulsification followed by the insertion of a posterior intraocular lens was performed on the left eye. Due to an elevated intraocular pressure after the surgery, which could not be controlled either by several eyedrops, or by three more operations (one viscocanalostomy with mitomycin c, two cyclophotocoagulations), therefore, a final attempt with bimatoprost (Lumigan) was started. Two weeks later the patient complained of blurred vision, caused by a cystoid macular edema.. After discontinuation of bimatoprost and initiation of a local and systemic anti-inflammatory therapy, the edema resolved and visual acuity recovered.. Bimatoprost (Lumigan) , a synthetic prostamid is similar to human prostaglandins, especially to prostaglandin F (2alpha.) Although it does not bind to the same receptor, its side effects are comparable to those of common prostaglandin analogues. So far there are no reports about the manifestation of a macular edema after using bimatoprost in pseudophakic eyes with an intact posterior capsule. Even if three more operations followed the cataract surgery, we suspect that bimatoprost eyedrops can be held responsible for this. Therefore they should be used with great care and in clear indications, particularly in pseudophakic patients.

Topics: Administration, Topical; Aged; Amides; Bimatoprost; Cloprostenol; Glaucoma; Humans; Lipids; Macular Edema; Male; Pseudophakia

The aim of this study was to investigate the effects of bimatoprost 0.03% on ocular hemodynamics in patients with normal tension glaucoma (NTG).. Twenty-two (22) patients with NTG were consecutively recruited. After basic eye examination and diurnal intraocular pressure (IOP) measurement, color Doppler imaging was used to measure the peak systolic and end diastolic velocities and resistive index of the central retinal, lateral posterior ciliary, and medial posterior ciliary arteries. Patients received bimatoprost 0.03% for 4 weeks, and these measurements were then repeated. The worse eye of each NTG patient was used in the statistical analysis.. Bimatoprost 0.03% significantly reduced mean IOP from 15.1 +/- 3.8 mmHg at baseline to 12.0 +/- 2.9 mmHg after treatment in our sample of NTG patients (P < 0.001). No significant changes in blood velocities or resistance indices were observed in the retrobulbar vessels after the 4-week treatment.. Topical bimatoprost 0.03% significantly reduced IOP in our NTG patients without causing significant hemodynamic changes in the retrobulbar vessels.

Topics: Aged; Aged, 80 and over; Amides; Bimatoprost; Circadian Rhythm; Cloprostenol; Female; Glaucoma; Humans; Intraocular Pressure; Lipids; Male; Middle Aged

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cost-Benefit Analysis; Drug Costs; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Lipids; Ocular Hypertension; Prostaglandins F, Synthetic; Travoprost

To confirm the efficacy of the travoprost treatment during twelve months follow-up in groups of patients: without previous treatment, with different previous anti-glaucomatous treatment, and with different stage of compensation.. The study evaluates the lowering of the intraocular pressure (IOP) in 143 patients (286 eyes). The intraocular pressure was measured by means of aplanation tonometry, before the treatment started, and after 1, 3, 9, and 12 months at 8-9 o'clock a.m. Patients were divided into eight groups according to the previous mono therapy or combined therapy substituted by travoprost mono therapy or its combination. A special group constituted patients with travoprost as a primary treatment.. In the first group, with latanoprost substituted by travoprost, the intraocular pressure decreased by 7% (p < or = 0.0001). In the second group of patients, with travoprost as the primary glaucoma treatment, the intraocular pressure decreased by 22% (p < or = 0.0001). In the third group, the beta-blocker was substituted by travoprost, with 22 % (p < or = 0.0001) decrease of the IOP. In the fourth group, the combined therapy of beta-blocker with latanoprost was substituted by combination of beta-blocker and travoprost and the decrease by 8% (p < or = 0.0001) was significant during the first nine months of the follow-up period, later on, the decrease was not significant. The substitution of the combination of beta-blocker and latanoprost by travoprost mono therapy in the fifth group created only no significant lowering of the IOP during the whole follow-up period. If the travoprost mono therapy substituted the combination of beta-blocker with local carboanhydrase inhibitor in the sixth group, the IOP decreased by 20% (p < or = 0.001). In the seventh group, the combination of the local carboanhydrase inhibitor and latanoprost was substituted by combination of the local carboanhydrase inhibitor with travoprost, the IOP lowering was not significant. On the other hand, in the eighth group, different combinations of antiglaucomatics were substituted by travoprost, and this caused significant lowering of IOP by 20% (p < or = 0.0001). In all cases, the lowest decrease of IOP during the whole follow-up period in the eye with worse compensation is given.. Travoprost lowered effectively the intraocular pressure in 6 out of 8 groups of patients, e.g. in 129 patients (out of 143 patients), the range of lowering was 7-28% bellow the initial level, the follow up period was 12 months. The decrease of the IOP was stable. The drug was well tolerated.

Topics: Cloprostenol; Female; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Male; Prostaglandins F, Synthetic; Travoprost

Topics: Amides; Bimatoprost; Cloprostenol; Glaucoma; Humans; Intraocular Pressure; Lipids; Ocular Hypertension; Patient Selection; Travoprost; Treatment Outcome

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Drug Combinations; Glaucoma; Humans; Intraocular Pressure; Lipids; Ocular Hypertension; Ophthalmic Solutions; Randomized Controlled Trials as Topic; Sulfonamides; Thiophenes; Timolol

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cost-Benefit Analysis; Drug Costs; Glaucoma; Humans; Latanoprost; Lipids; Ophthalmic Solutions; Prostaglandins F, Synthetic; Travoprost

To examine central corneal mechanical sensitivity (CCMS) after the instillation of latanoprost, travoprost, and bimatoprost.. Nonrandomized interventional study.. Latanoprost was used in 24 patients (43 eyes), travoprost in 21 patients (42 eyes), and bimatoprost in 15 patients (28 eyes). CCMS was examined with the Cochet-Bonnet esthesiometer before the instillation of prostaglandin analogs and then 5 and 30 minutes later. Examination of Schirmer and breakup time (BUT) tests were also performed. Thirty healthy subjects were examined as a control group.. CCMS was significantly reduced at the 5-minute interval for latanoprost (P = .03), travoprost (P = .04), and bimatoprost (P = .04). Differences between the three analogs were statistically not significant. CCMS changes significantly correlated with Schirmer and BUT test scores.. The correlation between CCMS reduction and BUT and Schirmer test scores implies that the use of artificial tears may be considered if prostaglandin analogs are administered.

Topics: Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cornea; Female; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Lipids; Male; Middle Aged; Ophthalmic Solutions; Prostaglandins F, Synthetic; Sensation; Sensation Disorders; Travoprost

Topics: Amides; Antihypertensive Agents; Aqueous Humor; Bimatoprost; Cloprostenol; Drinking; Glaucoma; Humans; Intraocular Pressure; Lipids; Tonometry, Ocular; Water

Glaucoma is a condition affecting one or both eyes with raised intraocular pressure (IOP). IOP should be reduced to prevent progression of visual field loss. This study investigates the cost-effectiveness of bimatoprost compared with latanoprost as first-line monotherapies in the treatment of glaucoma in Austria, Finland and France. On the basis of a single multicentre, randomised, investigator-masked controlled trial, a 6- and 12-month cost-effectiveness model was designed following the treatment recommendations from the European Glaucoma Society. Treatment changes due to insufficient IOP reduction and adverse events were included. The cost-effectiveness analysis showed that the need for adjunctive therapy was the major cost driver. On the basis of evidence from the randomised, investigator-masked clinical trial (RCT), the cost-effectiveness analysis found that bimatoprost was a cheaper and a more effective treatment strategy compared with latanoprost. This was true for all three countries and all IOP targets between 13 and 20 mmHg. The cost-effectiveness result may be generalised to a European setting and perspective.

Topics: Amides; Antihypertensive Agents; Austria; Bimatoprost; Chemotherapy, Adjuvant; Cloprostenol; Cost-Benefit Analysis; Drug Costs; Finland; France; Glaucoma; Humans; Latanoprost; Lipids; Models, Economic; Ophthalmic Solutions; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic

After application of bimatoprost containing eye drops for four weeks, a 72 year-old patient, suffering from glaucoma, developed hyperpigmentation and hypertrichosis of the eyelids. These symptoms can be seen in 1-10% of the patients as side effects in local therapy with bimatoprost, a prostaglandin analogue. The changes persist for varying periods of time but are reversible. Although prostaglandin analogues are sometimes more effective in the reduction of the intraocular pressure than beta-adrenoreceptor blocking agents, they remain second-line choices because of their side effects. This case report is meant to re-stimulate interest in the as yet obscure role of prostaglandins in hair biology, in clarifying the underlying mechanisms, and in exploring the possible therapeutic use of prostaglandin analogues in the management of hair loss (e.g. in androgenetic alopecia) or hair depigmentation (e.g. poliosis, canities).

Topics: Aged; Amides; Bimatoprost; Cloprostenol; Eyelid Diseases; Female; Glaucoma; Humans; Hyperpigmentation; Hypertrichosis; Lipids; Ophthalmic Solutions; Treatment Outcome

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Dinoprost; Evidence-Based Medicine; Fluorescein Angiography; Glaucoma; Humans; Latanoprost; Lipids; Prostaglandins F, Synthetic; Trabeculectomy; Travoprost

Topics: Aged; Cloprostenol; Exfoliation Syndrome; Female; Glaucoma; Humans; Ophthalmic Solutions; Travoprost; Uveitis, Anterior

To report a new adverse effect related to treatment with bimatoprost.. Serial clinical examination of three patients was performed. In each of the three reported patients, alteration of eyelid appearance with deepening of the lid sulcus was evident as the result of topical bimatoprost therapy.. A comprehensive literature search of Medline using WebMd and MDConsult, was conducted to cross reference known side effects of topical prostaglandin analog treatment. The keywords utilized were prostaglandin analogs, prostaglandins, prostamide, glaucoma, ocular hypertension, intraocular pressure, side effects, adverse effects, bimatoprost, latanoprost, lumigan, and xalatan. This appears to be the first such report in the literature. Clinicians and patients should be made aware of this possible complication of topical bimatoprost therapy.

Topics: Administration, Topical; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Eyelid Diseases; Female; Glaucoma; Humans; Intraocular Pressure; Lipids; Male; Middle Aged; Ophthalmic Solutions

Therapeutic decisions (treatment initiation, continuation, change, combination, etc.) based on intraocular pressure (IOP) monitoring require knowledge of both circadian IOP fluctuations and the pharmacological circadian rhythm of the active ingredients. A simple model was applied to data from two clinical trials to estimate the consequences of circadian IOP fluctuations on (1) ocular hypertension diagnosis, (2) therapeutic adjustments, and (3) the daily cumulative effect of marginally low therapeutic differences. A grid for clinical interpretation of the average IOP differences is presented. The probability of an IOP that exceeds the target value for the diagnosis or therapy varied to a large extent throughout the day. IOP was higher in the morning than in the evening. The IOP variance (measured by standard deviation) was an important factor in decision-making, regardless of the IOP value itself. Regular IOP monitoring over the entire day allowed minimization of the time spent above a target value. IOP differences that seemed low when expressed in average values in therapeutic trials could have clinically significant consequences in the practitioner's decisions. The data presented suggest that ocular hypertension diagnosis and therapeutic decisions should be made early in the morning, at least for most patients. In any case, the time of the measurement should be considered in the therapeutic approach.

Topics: Biotransformation; Chronotherapy; Circadian Rhythm; Cloprostenol; Decision Making; Genetic Variation; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Models, Biological; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic; Travoprost

To compare the ocular hypotensive effect of the commercially available preparations of bimatoprost or travoprost added to latanoprost in monkey eyes with laser-induced unilateral glaucoma.. Four monkeys with unilateral laser-induced glaucoma were used in each treatment group and received drops in the glaucomatous eye only. Intraocular pressure (IOP) was measured hourly for 6 hours, beginning at 9:30 am on day 1 (untreated baseline), days 6 and 7 (single-agent therapy), and days 13 and 14 (2-drug combination therapy). On days 2 through 7, 1 drop of the scheduled single agent was given immediately after the 9:30 am IOP measurement, and on days 8 through 14, the second scheduled drug was given 5 minutes after the first. The following 5 different dosing protocols were studied: latanoprost with bimatoprost added, bimatoprost with latanoprost added, latanoprost with travoprost added, travoprost with latanoprost added, and latanoprost with a second dose of latanoprost added.. There were no statistically significant (P =.95) differences among the mean baseline IOPs in any of the 5 treatment groups. When applied as single agents, latanoprost, bimatoprost, and travoprost all produced significant (P<.05) and equivalent (P =.98) reductions in IOP. The mean +/-SEM maximum reduction (P<.05) from baseline IOP was 7.0 +/- 0.4 mm Hg (20% reduction) with travoprost alone, 6.5 +/- 1.6 mm Hg (18%) with bimatoprost alone, and 7.5 +/- 1.0 mm Hg (22%) with latanoprost alone. The mean +/-SEM maximum additive reductions in IOP were 3.0 +/- 0.6 mm Hg (P<.05) for travoprost added to latanoprost; 2.0 +/- 0.4 mm Hg (P<.05) for latanoprost added to travoprost; 4.8 +/- 1.3 mm Hg (P<.05) for bimatoprost added to latanoprost; 4.3 +/- 0.6 mm Hg (P<.05) for latanoprost added to bimatoprost; and 0.3 +/- 0.5 mm Hg (P>.60) for latanoprost added to itself. The combination of bimatoprost and latanoprost produced a greater (P<.05) lowering of IOP at trough and peak than the combination of travoprost and latanoprost.. Latanoprost, bimatoprost, and travoprost used as monotherapy produced significant and equivalent reductions in IOP in glaucomatous monkey eyes. The IOP effects of the commercial concentrations of bimatoprost or travoprost were additive to that of latanoprost, with bimatoprost showing a greater additive response than travoprost. Clinical Relevance Because treatment with multiple medications is common among patients with glaucoma, determining which glaucoma medications produce an additive ocular hypotensive response when used in combination has practical implications for clinicians.

Topics: Amides; Animals; Antihypertensive Agents; Bimatoprost; Cloprostenol; Disease Models, Animal; Drug Therapy, Combination; Female; Glaucoma; Intraocular Pressure; Latanoprost; Lipids; Macaca fascicularis; Prostaglandins F, Synthetic; Travoprost

Replacement of the carboxylic acid group of prostaglandin (PG) F(2alpha) with a nonacidic moiety, such as hydroxyl, methoxy, or amido, results in compounds with unique pharmacology. Bimatoprost (AGN 192024) is also a pharmacologically novel PGF(2alpha) analog, where the carboxylic acid is replaced by a neutral ethylamide substituent. Bimatoprost potently contracted the feline lung parenchymal preparation (EC(50) value of 35-55 nM) but exhibited no meaningful activity in a variety of PG-sensitive tissue and cell preparations. Its activity seemed unrelated to FP receptor stimulation according to the following evidence. 1) Bimatoprost exhibited no meaningful activity in tissues and cells containing functional FP receptors. 2) Bimatoprost activity in the cat lung parenchyma is not species-specific because its potent activity in this preparation could not be reproduced in cells stably expressing the feline FP receptor. 3) Radioligand binding studies using feline and human recombinant FP receptors exhibited minimal competition versus [(3)H]17-phenyl PGF(2a) for Bimatoprost. 4) Bimatoprost pretreatment did not attenuate PGF(2alpha)-induced Ca(2+) signals in Swiss 3T3 cells. 5) Regional differences were apparent for Bimatoprost but not FP agonist effects in the cat lung. Bimatoprost reduced intraocular pressure in ocular normotensive and hypertensive monkeys over a 0.001 to 0.1% dose range. A single-dose and multiple-dose ocular distribution/metabolism studies using [(3)H]Bimatoprost (0.1%) were performed. Within the globe, bimatoprost concentrations were 10- to 100-fold higher in anterior segment tissues compared with the aqueous humor. Bimatoprost was overwhelmingly the predominant molecular species identified at all time points in ocular tissues, indicating that the intact molecule reduces intraocular pressure.

Topics: Amides; Animals; Bimatoprost; Calcium Signaling; Cats; Cloprostenol; Colon; Dinoprost; Eye; Female; Gastric Fundus; Genes, Reporter; Gerbillinae; Glaucoma; Humans; Ileum; In Vitro Techniques; Inositol Phosphates; Intraocular Pressure; Lipids; Luciferases; Mice; Muscle Contraction; Muscle, Smooth; Rats; Receptors, Prostaglandin

Ocular blood flow dysregulation is considered to be a risk factor associated with the optic neuropathy observed in glaucoma patients. The present study evaluates the vasoactive effect of the ocular hypotensive agent travoprost (Travatan) on isolated pig ciliary arteries.. Isometric forces were measured with a myograph system. Quiescent vessels were exposed in a cumulative manner to increasing concentrations (0.1 nM - 0.1 mM) of travoprost ([+]-fluprostenol). Vessels pre-contracted with 100 mM potassium chloride (KCl) or 10 nM endothelin-1 were also exposed in a similar manner to travoprost. Time-control experiments without travoprost were always run in parallel. In quiescent vessels, contractions were expressed in percent of 100 mM KCl-induced contractions. In vessels pre-contracted with endothelin-1, relaxations were expressed in percent of the maximal contraction induced by this peptide, while in those pre-contracted with KCl, relaxations were expressed in percent of the plateau-contraction reached 30 minutes after the application of this drug.. In quiescent vessels, travoprost had no statistically significant vasoconstrictive effect. In KCl- or in endothelin-1 pre-contracted vessels, travoprost had no statistically significant vasorelaxing effect.. Although the clinical relevance of the results of this study for patients treated with travoprost (Travatan) needs to be further investigated, travoprost appears to have no vasoconstrictive properties in isolated porcine ciliary arteries.

Topics: Animals; Ciliary Arteries; Cloprostenol; Dose-Response Relationship, Drug; Glaucoma; In Vitro Techniques; Intraocular Pressure; Optic Neuropathy, Ischemic; Prostaglandins F, Synthetic; Swine; Travoprost; Vascular Resistance; Vasoconstriction

To investigate the vasoactive effect of bimatoprost (Lumigan), a new topical ocular hypotensive agent, in isolated porcine ciliary arteries.. Arteries were placed in a myograph system to measure isometric forces. Quiescent vessels as well as vessels pre-contracted with either 10 nM endothelin-1 or 100 mM potassium chloride (KCl) were exposed, in a cumulative manner, to increasing concentrations (0.1 nM - 0.1 mM) of bimatoprost (dissolved in ethanol). In quiescent vessels, results were expressed in percent of 100 mM KCl-induced contraction. In endothelin-1-pre-contracted vessels, results were expressed in percent of the maximal contraction induced by endothelin-1. In KCl-pre-contracted vessels, results were expressed in percent of the plateau contraction reached 30 minutes after 100 mM KCl application.. Bimatoprost induced a significant (p < 0.05 - 0.001) vasoconstriction at concentrations equal to or higher than 0.1 micro M in quiescent vessels (0.1 mM: 73 +/- 12 %). In KCl-pre-contracted vessels, at concentrations higher than 1 micro M, bimatoprost induced significant (p < 0.05 - 0.01) contractions (0.1 mM: 67 +/- 17 %). In endothelin-1-pre-contracted vessels, bimatoprost also induced significant (p < 0.05 - 0.001) contractions at concentrations above 10 micro M (0.1 mM: 17 +/- 8 %).. The present study indicates that bimatoprost appears to have, in vitro, some vasoactive properties in porcine ciliary arteries. The question whether Lumigan has an influence on ocular blood flow needs to be further investigated.

Topics: Amides; Animals; Antihypertensive Agents; Aqueous Humor; Bimatoprost; Cloprostenol; Culture Techniques; Dose-Response Relationship, Drug; Endothelin-1; Glaucoma; Intraocular Pressure; Lipids; Optic Neuropathy, Ischemic; Potassium Chloride; Prostaglandins F, Synthetic; Regional Blood Flow; Swine; Vasoconstriction

Connective tissue growth factor (CTGF) and Cyr61 (cysteine-rich angiogenic protein 61) are members of the CCN gene family that encode multifunctional, extracellular matrix-associated signaling proteins. Because the mechanism of action of certain anti-glaucoma drugs involves extracellular matrix remodeling of ocular ciliary muscle, with a resultant increase in drainage of aqueous humor from the eye, we compared the effects of three pharmacologically distinct ocular hypotensive agents on Cyr61 and CTGF gene expression. Thus, prostaglandin F2alpha (PGF2alpha) (FP receptor agonist), Butaprost (EP2 receptor agonist), and Bimatoprost (a prostamide) were compared. Using Affymetrix gene chip technology, we first identified that PGF2alpha dramatically up-regulated Cyr61 and CTGF mRNA expression in HEK 293/EBNA cells (hFP-HEK 293/EBNA). Northern blot further confirmed the Cyr61 and CTGF up-regulation is in a dose- and time-dependent manner. PGF2alpha-induced up-regulation of Cyr61 appeared to exclusively involve the Rho pathway, and up-regulation of CTGF was via multiple intracellular pathways. Because prostamide receptors are, to date, defined only at the pharmacological level, Bimatoprost effects on Cyr61 and CTGF were studied in the isolated feline iris sphincter preparation, a tissue highly responsive to prostamides. Both PGF2alpha and Bimatoprost up-regulated Cyr61 mRNA expression in the cat iris tissue. Only PGF2alpha up-regulated CTGF mRNA expression in the cat iris. Therefore, PGF2alpha and Bimatoprost appear to interact with different receptors populations in the cat iris, according to their markedly different effects on CTGF. Activation of prostaglandin EP2 receptors (Gs-coupled) also up-regulated Cyr61 but not CTGF mRNA expression in the isolated cat iris. Similar data were observed in human primary ciliary smooth muscle cells. Thus, despite quite different signal transduction pathways, FP receptor stimulation up-regulates CTGF and Cyr61. The prostamide analog Bimatoprost and an EP2-selective agonist affects only Cyr61.

Topics: Alprostadil; Amides; Animals; Bimatoprost; Cats; Cell Line; Cells, Cultured; Ciliary Body; Cloprostenol; Connective Tissue Growth Factor; Cysteine-Rich Protein 61; Dinoprost; Gene Expression; Glaucoma; Humans; Immediate-Early Proteins; In Vitro Techniques; Intercellular Signaling Peptides and Proteins; Iris; Kinetics; Lipids; Oligonucleotide Array Sequence Analysis; Promoter Regions, Genetic; RNA, Messenger; Signal Transduction; Trabecular Meshwork; Up-Regulation

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Lipids; Ocular Hypertension; Prostaglandins F, Synthetic; Randomized Controlled Trials as Topic; Research Design

Open-angle glaucoma affects an estimated 33 million individuals worldwide. An intraocular pressure >21 mm Hg in individuals with no evidence of optic nerve damage is termed ocular hypertension, a risk factor for glaucoma that has been estimated to affect as many as 10% of individuals 40 years of age or older.. The purpose of this research was to assess persistency (time on therapy) with prostaglandin analogues in the treatment of glaucoma or ocular hypertension.. This population-based, retrospective cohort study used the Protocare Sciences managed care database, which includes prescription and medical claims data from multiple managed care organizations. Patients 20 years of age or older who initiated therapy with latanoprost, bimatoprost, or travoprost (index drugs) between April 2001 and June 2002 were included. Patients were required to be continuously enrolled in the same plan for the 180 days preceding index prescription fill. Follow-up continued through June 30, 2002. Two outcome measures were analyzed: (1) discontinuation of the index prostaglandin and (2) either discontinuation or change in the index prostaglandin regimen. Changing therapy was defined as switching to or adding another ocular hypotensive agent. Cox regression models were used to compare rate ratios of discontinuation and discontinuation/change. Patient data were censored on termination of insurance coverage or at the end of the study period.. Overall, 7527 patients were prescribed a prostaglandin analogue; 4356 patients met the inclusion criteria (n = 2376, 993, and 987 for latanoprost, bimatoprost, and travoprost, respectively). A total of 58% of patients were women, and 74% were 65 years of age or older. Compared with latanoprost, those treated with bimatoprost were 38% more likely to discontinue and 31% more likely to discontinue/change therapy, and patients treated with travoprost were 36% more likely to discontinue and 29% more likely to discontinue/change therapy (P < 0.001 for each comparison).. Latanoprost-treated patients demonstrated significantly (P < 0.001) greater persistency than did those treated with either bimatoprost or travoprost.

Topics: Administration, Topical; Adult; Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cohort Studies; Female; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Lipids; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Patient Compliance; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Retrospective Studies; Self Administration; Travoprost

To describe a previously unreported case of anterior granulomatous uveitis in a patient using bimatoprost.. A 72-year-old woman with a long-standing history of anisometropic amblyopia and pseudoexfoliative glaucoma in the right eye started therapy with bimatoprost 0.03% once a day in the right eye. She had no previous history of ocular inflammation or ocular surgery. Her medical history was negative for systemic diseases associated with ocular inflammation.. After one week, the patient developed severe conjunctival injection, cells and flare, and numerous 'mutton fat' keratic precipitates in the right eye. Examination of the left eye revealed no evidence of inflammation. Bimatoprost was discontinued; no topical steroid therapy was started. Systemic investigations were normal. The inflammation resolved over two weeks, solely with the discontinuation of bimatoprost.. Bimatoprost is a synthetic prostamide, chemically related to prostamide F. Prostamides are naturally occurring substances, biosynthesized from anandamide in a pathway that includes COX2. Even though anandamide has proven suggestive potential pro-inflammatory effects, the mechanism of induction of inflammation by bimatoprost remains uncertain and speculative. In our report, the onset of acute uveitis in a patient using bimatoprost, after a long-term and well-tolerated treatment with a prostaglandin analog, suggests a distinct potential pro-inflammatory action of prostamides. This can indirectly support the concept that the target receptor of bimatoprost is different, and that the mechanism of action of prostamides is pharmacologically unique.

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Exfoliation Syndrome; Female; Glaucoma; Granuloma; Humans; Intraocular Pressure; Lipids; Uveitis, Anterior

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Glaucoma; Humans; Intraocular Pressure; Latanoprost; Lipids; Ocular Hypertension; Prostaglandins F, Synthetic; Travoprost

A 72-year-old man with long-standing bilateral glaucoma became refractory to levobunolol ophthalmic solution therapy after many years. Brimonidine was prescribed, but the patient developed a hypersensitivity several months later that was treated with loteprednol ophthalmic suspension. Bimatoprost was initiated 2 weeks later. Within an hour of the first dose of bimatoprost, the patient reported eye pain and photophobia that remained unresolved the following day. Examination revealed acute bilateral nongranulomatous anterior uveitis that was effectively treated with loteprednol. While observations in human and animal models suggest an association between certain prostaglandin-like agents and intraocular inflammation, this report is one of the first to suggest a link between bimatoprost and intraocular inflammatory reaction.

Topics: Aged; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Glaucoma; Humans; Intraocular Pressure; Lipids; Male; Uveitis, Anterior; Visual Acuity

Topics: Amides; Aminosalicylic Acids; Anti-Ulcer Agents; Antipsychotic Agents; Bimatoprost; Cloprostenol; Cyclohexanes; Drug Approval; Drug Therapy; Drug-Related Side Effects and Adverse Reactions; Galantamine; Glaucoma; Gonadotropin-Releasing Hormone; Humans; Hypoglycemic Agents; Insulin; Insulin Glargine; Insulin, Long-Acting; Lipids; Mesalamine; Nateglinide; Nootropic Agents; Phenylalanine; Phenylhydrazines; Piperazines; Thiazoles; Travoprost

The changes in intraocular pressure and pupil size in glaucomatous dogs were evaluated after instillations of 0.03% bimatoprost (Lumigan, Allergan, Irvine, CA USA) once in the morning, or once in the evening, or twice daily in five day multiple dose studies. Applanation tonometry (IOP) and pupil size (PS) measurements were obtained at 8 am, 10 am, 12 noon, 2 pm, and 4 pm in 8 glaucoma dogs. Methylcellulose (0.5% as placebo) was instilled in the control eye, and 0.03% bimatoprost was instilled in the opposite drug eye. Methylcellulose (0.5%) and 0.03% bimatoprost were instilled the second through the fifth days with instillations in the morning (8:30 am), or evening (8 pm), or twice daily (8:30 am and 8 pm). The mean +/- SEM diurnal changes in IOP from baseline values after 0.03% bimatoprost at 8 am once daily for the next four days were 25.0 +/- 3.2 mm Hg, 25.6 +/- 2.9 mm Hg, 25.5 +/- 3.0 mm Hg, and 26.0 +/- 3.2 mm Hg respectively, and were significantly different from the control eye. After bimatoprost was instilled at 8 pm, the mean +/- SEM changes in IOP from baseline values in the drug eyes were 27.3 +/- 2.4 mm Hg, 26.6 +/- 2.2 mm Hg, 27.2 +/- 2.5 mm Hg, and 27.3 +/- 2.6 mm Hg respectively. When 0.03% bimatoprost was instilled twice daily, the mean +/- SEM changes in IOP from baseline values were 39.1 +/- 2.3 mm Hg, 39.9 +/- 2.2 mm Hg, 39.9 +/- 2.3 mm Hg, and 39.6 +/- 2.1 mm Hg respectively, and were significantly different from the control eyes. Miosis of varying duration was frequent during the three studies. Bimatoprost instilled once daily (am or pm) as well as twice daily produces significant decreases in IOP and PS in the glaucomatous Beagle.

Topics: Amides; Animals; Bimatoprost; Cloprostenol; Dogs; Drug Administration Schedule; Female; Glaucoma; Intraocular Pressure; Lipids; Male; Methylcellulose; Ophthalmic Solutions; Placebos; Pupil

Topics: Amides; Bimatoprost; Cloprostenol; Dinoprost; Glaucoma; Humans; Intraocular Pressure; Laser Therapy; Latanoprost; Lipids; Practice Guidelines as Topic; Prostaglandins F, Synthetic; Travoprost; United States

To report angiographically documented cystoid macula edema associated with the use of each of the three newly available ocular hypotensive lipids: unoprostone, travaprost, and bimatoprost.. Observational case series.. Retrospective review of three patients in a clinical practice who had uncontrolled glaucoma on maximal tolerable therapy except for an ocular hypotensive lipids. All three patients also had previous cataract and filtration surgery, and all had an absent or open posterior lens capsule. The patients were informed of the potential risks of cystoid macula edema associated with the use of an ocular hypotensive lipids versus the risks of repeat filtration surgery.. An ocular hypotensive lipids was started in the affected eye in each patient, and the patient was instructed to check visual acuity everyday and report back any change in vision occurred.. Decreased vision of at least two lines caused by angiographically confirmed cystoid macula edema was noted in each of three patients started, respectively, on unoprostone, travaprost, and bimatoprost. The visual acuity returned to baseline, and the cystoid macula edema was angiographically resolved after discontinuation of the ocular hypotensive lipids and the initiation of a topical steroid and non-steroidal anti-inflammatory eyedrops. Until a causal relationship between cystoid macula edema and ocular hypotensive lipids is proved or disproved, caution in their use in high-risk eyes would be prudent.

Topics: Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Dinoprost; Female; Fluorescein Angiography; Glaucoma; Humans; Intraocular Pressure; Lens Implantation, Intraocular; Lipids; Macular Edema; Male; Phacoemulsification; Retrospective Studies; Trabeculectomy; Travoprost; Visual Acuity

To report a case of herpes simplex virus reactivation after starting bimatoprost treatment for glaucoma.. Interventional case report.. A 66-year-old woman had a herpes simplex keratouveitis reactivation that occurred within 1 month after starting bimatoprost. The herpes simplex had been inactive for more than 10 years.. Bimatoprost and prednisolone acetate 0.12% were discontinued; oral acyclovir, ofloxacin, and betaxolol 0.25% were initiated. Two weeks later, prednisolone acetate 1% was added. The reactivation resolved, and 1 month later, the best corrected visual acuity improved to 20/40.. Caution should be used in prescribing bimatoprost for patients with a history of herpes simplex virus keratitis.

Topics: Acyclovir; Aged; Amides; Anti-Infective Agents; Anti-Inflammatory Agents; Antihypertensive Agents; Antiviral Agents; Betaxolol; Bimatoprost; Cloprostenol; Drug Therapy, Combination; Female; Glaucoma; Herpesvirus 1, Human; Humans; Intraocular Pressure; Keratitis, Herpetic; Lipids; Ofloxacin; Prednisolone; Virus Activation; Visual Acuity