travoprost and Hyperemia

This study will evaluate the efficacy of travoprost for patients with glaucoma systematically.. A comprehensive literature search will be carried from following literature sources from inception to the present: Cochrane Library, MEDLINE, EMBASE, Web of Science, Google scholar, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure. We will only consider randomized controlled trials on assessing the efficacy and safety of travoprost for glaucoma for inclusion. We will use Cochrane risk of bias tool for the methodological quality assessment for each qualified study. If it is possible, we will pool the outcome data, and will perform meta-analysis.. This study will systematically evaluate the efficacy and safety of travoprost for glaucoma. Primary outcomes include intraocular pressure (IOP), mean IOP, and mean reduction of IOP. Secondary outcomes consist of diastolic ocular perfusion pressure, central corneal thickness, and quality of life, as measured by 36-Item Short Form Health Survey, and treatment-related adverse events included hyperemia, eye pain, and eye pruritus.. The findings of the present study will summarize the updated evidence of travoprost for patients with glaucoma.PROSPERO registration number: PROSPERO CRD42019126956.

Topics: Antihypertensive Agents; Corneal Pachymetry; Eye Pain; Glaucoma; Humans; Hyperemia; Intraocular Pressure; Pruritus; Quality of Life; Randomized Controlled Trials as Topic; Travoprost

Prostaglandin-timolol fixed combinations (PG-timolol FCs) are now widely used to reduce intraocular pressure in patients with glaucoma. The efficacy and tolerability of these drugs are worthy of further exploration. An updated systematic review and meta-analysis was performed to assess the clinical efficacy and tolerability of the three PG-timolol FCs.. Pertinent randomized, controlled trials were identified through systematic searches of PubMed, Embase, the Cochrane central register of controlled trials and the Chinese Biomedicine Database. The main efficacy measures were the weighted mean differences (WMDs) for the reduction from baseline to end of treatment in IOP at 9 am, 12 pm and 4 pm and diurnal curve. The main tolerability measures were the odds ratios (ORs) for the incidence of conjunctival hyperemia.. Nine studies involving 991 patients were included in the meta-analysis. Latanoprost-timolol FC (LTFC) and travoprost-timolol FC (TTFC) were not significantly different in lowering IOP at diurnal mean, 9 am, 12 pm and 4 pm. Bimatoprost-timolol FC (BTFC) provided significantly greater efficacy in lowering IOP at the three measurement time points and over the mean diurnal curve than LTFC (diurnal curve: WMD = 0.88 mmHg [95% CI, 0.42 to 1.33]; 9 am: WMD = 1.27 mmHg [0.68 to 1.86]; 12 pm: WMD = 1.16 mmHg [0.85 to 1.46]; 4 pm: WMD = 0.61 mmHg [0.51 to 0.70]) and TTFC (diurnal curve: WMD = 1.94 mmHg [0.19 to 3.68]; 9 am: WMD = 0.68 mmHg [0.15 to 1.21]; 12 pm: WMD = 0.90 mmHg [0.41 to 1.39]; 4 pm: WMD = 1.06 mmHg [0.61 to 1.51]). The incidence of hyperemia was significantly higher with BTFC than LTFC (pooled ORs: 1.85 [1.09 to 3.13]). The incidence of hyperemia was not significantly higher with TTFC than LTFC (pooled ORs: 2.52 [0.85 to 7.46]), and was not significantly higher with BTFC than TTFC (pooled OR: 1.65 [0.48 to 5.70]).. BTFC provided significantly greater efficacy in lowering IOP at diurnal mean, 9 am, 12 pm and 4 pm than LTFC and TTFC. LTFC was as effective as TTFC in lowering IOP at the four measurement time points and BTFC caused conjunctival hyperemia in more patients than LTFC. Further clinical trials are needed because of the limited number of studies.

Topics: Antihypertensive Agents; Bimatoprost; Drug Combinations; Glaucoma; Humans; Hyperemia; Intraocular Pressure; Latanoprost; Prostaglandins F, Synthetic; Timolol; Travoprost

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

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

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

It is reported that nonsteroidal anti-inflammatory drug (NSAID) ophthalmic solution affected the therapeutic efficacy of prostaglandin (PG) analog by inhibiting endogenous PG production. However, whether NSAID ophthalmic solution interferes with its conjunctival hyperemia is unknown. We investigated the effect of NSAID ophthalmic solution on its hyperemia.. This was a prospective, randomized, double-blind, placebo-controlled 1-month trial. Benzalkonium chloride-free travoprost 0.004% was used as a PG analog and administered once daily (08:00) in both eyes. Bromfenac sodium hydrate was assigned randomly to 1 eye twice daily (08:00 and 20:00) (the NSAID side), whereas flavin adenine dinucleotide sodium was applied to the fellow eye of each patient twice daily (08:00 and 20:00) (the control side). Conjunctival photographs of both eyes were taken 3 times (08:00, 14:00, 20:00) on days 1, 2, 7, and 28, and hyperemia was scored from 0 to 5 (H-score). We compared H-scores on the NSAID and control sides.. Twenty-eight Japanese normal subjects completed the study. The H-score on the NSAID side was significantly lower than that on the control side on day 1 at 14:00 (P=0.016, paired t test) and day 2 at 14:00 (P=0.016). But there were no differences at 20:00 on each day and after that time.. The use of NSAID ophthalmic solution had almost no impact on PG analog-related conjunctival hyperemia. This partly suggests that the action mechanism of endogenous PG after administrating PG analog might be no correlation with conjunctival hyperemia.

Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Antihypertensive Agents; Benzophenones; Bromobenzenes; Conjunctiva; Conjunctival Diseases; Double-Blind Method; Female; Humans; Hyperemia; Intraocular Pressure; Male; Middle Aged; Ophthalmic Solutions; Prospective Studies; Time Factors; Travoprost; Young Adult

Prostaglandin analogs reduce intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension; however, these medications may affect the ocular surface and elicit ocular discomfort when preserved with benzalkonium chloride (BAK).. This was an open-label, single-arm study conducted in Latin America from February 2012 to May 2013. Patients with open-angle glaucoma or ocular hypertension who were intolerant of latanoprost 0.005 % were transitioned to receive once-daily BAK-free travoprost 0.004 % containing polyquaternium-1 (Travatan® preserved with POLYQUAD® [PQ], Alcon Laboratories, Inc; Fort Worth, TX) for 12 weeks. Mean change in IOP from baseline (primary efficacy endpoint) and the percentage of patients who achieved a target IOP of ≤18 mmHg were evaluated at all on-therapy visits. Ocular hyperemia, patient preference, and self-projected adherence were assessed at week 12. Adverse events (AEs) were monitored throughout the study.. All enrolled patients were included in the analysis (n = 191); the majority of patients (90.6 %, n = 173/191) completed the study. Mean (SD) patient age was 67.5 (11.3) years, and mean baseline IOP was 14.8 mmHg. Mean IOP was reduced by 0.94 mmHg at week 6 and by 1.09 mmHg at week 12 (P < 0.001 for both). A greater percentage of patients achieved a target IOP of ≤18 mmHg at week 6 (93.1 %; n = 163/175) and week 12 (93.3 %; n = 166/178) compared with baseline (89.5 %; n = 171/191). There was a 10.5 % increase in the percentage of patients with "none/trace" amounts of hyperemia. Most patients preferred the study medication (81.5 %; n = 141/173) and were confident that they would adhere to their preferred medication (90.8 %; n = 157/173). No serious AEs were reported, and eye irritation (3.7 %; n = 7/191) was the most common treatment-related AE.. Transitioning from BAK-containing latanoprost 0.005 % to BAK-free travoprost 0.004 % preserved with PQ reduced IOP in patients with open-angle glaucoma or ocular hypertension who were intolerant of latanoprost. BAK-free travoprost 0.004 % is a viable alternative for patients who require switching their IOP-lowering medications because of tolerability issues.. ClinicalTrials.gov identifier, NCT01510145.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Benzalkonium Compounds; Conjunctival Diseases; Corneal Diseases; Drug Substitution; Female; Glaucoma, Open-Angle; Humans; Hyperemia; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Preservatives, Pharmaceutical; Prostaglandins F, Synthetic; Tonometry, Ocular; Travoprost; Young Adult

There has been increased attention on the potential impact of the preservative benzalkonium chloride (BAK) on the ocular surface. This study compared the ocular surface tolerability of once-daily bimatoprost 0.01% and latanoprost 0.005% (both preserved with 0.02% BAK), and travoprost 0.004% preserved with sofZia™.. A randomized, multicenter (15 sites), investigator-masked study enrolled patients with open-angle glaucoma or ocular hypertension who had received latanoprost monotherapy for at least 1 month. Patients were randomized to oncedaily bimatoprost (n = 56), travoprost (n = 53), or latanoprost (n = 55) monotherapy for 3 months. Follow-up visits were at weeks 1, 4, and 12. The primary outcome measure was physician-graded conjunctival hyperemia (scale 0 to 3) at week 12. Secondary outcomes included corneal staining (scale 0 to 3) and tear break-up time (TBUT).. There were no significant differences in mean (standard deviation [SD]) outcome measures including conjunctival hyperemia (bimatoprost: 0.48 [0.52], travoprost: 0.49 [0.52], latanoprost: 0.51 [0.54]), corneal staining (bimatoprost: 0.31 [0.49], travoprost: 0.25 [0.46], latanoprost: 0.24 [0.45]), or TBUT (bimatoprost: 9.7 s [6.1], travoprost: 9.5 s [5.8], latanoprost: 9.8 s [5.0]) among subjects at latanoprost-treated baseline (P ≥ 0.664). At week 12, there were no significant differences in conjunctival hyperemia (bimatoprost: 0.42 [0.48], travoprost: 0.46 [0.44], latanoprost: 0.44 [0.57]), corneal staining (bimatoprost: 0.31 [0.45], travoprost: 0.32 [0.48], latanoprost: 0.22 [0.30]), or TBUT (bimatoprost: 9.7 s [5.7], travoprost 9.7 s [5.0], latanoprost: 9.3 s [4.0]) among the treatment groups (P ≥ 0.379). At week 1, there was a statistically significant among-group difference in mean change from baseline in hyperemia (+0.04, bimatoprost; +0.20, travoprost; 0.00, latanoprost; P = 0.018). There were no statistically significant among-group differences in mean corneal staining, mean TBUT, or change from baseline at any visit.. Despite preservative differences, there were no significant differences in objective clinical measures of ocular surface tolerability after 3 months of treatment with bimatoprost (with 0.02% BAK), travoprost (with sofZia), and latanoprost (with 0.02% BAK).

Topics: Aged; Amides; Benzalkonium Compounds; Bimatoprost; Cloprostenol; Conjunctival Diseases; Female; Glaucoma, Open-Angle; Humans; Hyperemia; Latanoprost; Male; Middle Aged; Ocular Hypertension; Preservatives, Pharmaceutical; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Travoprost

To compare the efficacy and safety of bimatoprost 0.01% with the fixed combination travoprost 0.004%/timolol 0.5% in subjects with stable intraocular pressure (IOP) control on latanoprost and timolol.. This was a randomized, prospective, investigator masked, crossover study comparing bimatoprost 0.01% with travoprost/timolol in 40 subjects diagnosed with primary open-angle glaucoma. Subjects were randomized to bimatoprost 0.01% qpm or travoprost/timolol qam and followed for 12 weeks, at which time they were crossed over to the alternate medication and followed for another 12 weeks. Intraocular pressure and hyperemia (rated on a standardized, 5-point photographic scale) were evaluated as change from baseline to 12 weeks following each therapy, and subject preference was elicited at the end of the study.. Both treatments were well tolerated and the majority of patients achieved effective IOP control relative to baseline. After 12 weeks of treatment, mean reductions from baseline IOP were -1.68 mmHg OD (right eye) and -1.58 mmHg OS (left eye) with bimatoprost and -0.45 mmHg OD and -0.53 mmHg OS with travoprost/timolol, although the differences between drugs were not statistically significant. Hyperemia scores were significantly higher with the fixed combination of travoprost/timolol than bimatoprost 0.01% as measured at 8 am (both P<0.01). Subject preference at the end of the study was more than 3 to 1 in favor of bimatoprost, with most citing greater tolerability.. Bimatoprost 0.01% and travoprost/timolol are both effective at reducing IOP in subjects with stable IOP control on latanoprost and timolol, but bimatoprost 0.01% is associated with less hyperemia.

Topics: Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Cross-Over Studies; Drug Combinations; Female; Glaucoma, Open-Angle; Humans; Hyperemia; Intraocular Pressure; Latanoprost; Male; Middle Aged; Patient Preference; Prospective Studies; Prostaglandins F, Synthetic; Single-Blind Method; Timolol; Travoprost; Treatment Outcome

To compare the ocular surface tolerability of latanoprost 0.005% preserved with 0.02% benzalkonium chloride (BAK), bimatoprost 0.03% preserved with 0.005% BAK, and travoprost 0.004% preserved with the proprietary preservative system sofZia in patients previously treated with latanoprost.. This randomized, multicenter, investigator-masked, parallel-group study enrolled patients with open-angle glaucoma or ocular hypertension who had been on latanoprost monotherapy for at least 4 weeks. At baseline, patients were randomized to receive once-daily bimatoprost (n=35), latanoprost (n=38), or travoprost (n=33) monotherapy for 3 months. Follow-up visits were at week 1, month 1, and month 3. The primary outcome measure was physician-graded conjunctival hyperemia at month 3. Secondary outcome measures included corneal staining with fluorescein and tear breakup time (TBUT).. There were no significant differences among the treatment groups in conjunctival hyperemia scores, corneal staining, or TBUT at the latanoprost-treated baseline or at any follow-up visit. Baseline mean (standard error of the mean) values were as follows--conjunctival hyperemia: bimatoprost 0.74 (0.10), latanoprost 0.74 (0.11), travoprost 0.86 (0.12), P=0.692; corneal staining: bimatoprost 0.59 (0.12), latanoprost 0.70 (0.13), travoprost 0.48 (0.11), P=0.423; TBUT (in seconds): bimatoprost 9.1 (1.0), latanoprost 8.6 (0.8), travoprost 7.9 (0.8), P=0.578. Month 3 values were as follows--conjunctival hyperemia: bimatoprost 0.80 (0.12), latanoprost 0.74 (0.10), travoprost 0.98 (0.13), P=0.340; corneal staining: bimatoprost 0.71 (0.78), latanoprost 0.47 (0.64), travoprost 0.36 (0.62), P=0.110; TBUT (in seconds): bimatoprost 9.7 (5.3), latanoprost 9.2 (5.3), travoprost 9.7 (6.3), P=0.909.. There were no significant differences among bimatoprost (preserved with 0.005% BAK), latanoprost (preserved with 0.02% BAK), and travoprost (preserved with sofZia) in objective clinical measures of ocular tolerability, including physician-graded hyperemia, corneal staining, and TBUT after 3 months of treatment. Longer-term studies are needed to further evaluate the ocular surface tolerability of these prostaglandin analogs.

Topics: Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Benzalkonium Compounds; Bimatoprost; Cloprostenol; Conjunctiva; Cornea; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Hyperemia; Latanoprost; Male; Middle Aged; Ocular Hypertension; Preservatives, Pharmaceutical; Prostaglandins F, Synthetic; Single-Blind Method; Tears; Travoprost; Treatment Outcome

To compare the subjective symptoms, conjunctival hyperemia, tearing response and conjunctival cytological changes secondary to topical administration of bimatoprost and travoprost for 6 months.. Newly diagnosed primary open-angle glaucoma patients were randomly prescribed bimatoprost (35 cases) or travoprost (42 cases). Two patients in each group were excluded because they did not appear at their appointments regularly. Thus, 33 and 40 patients completed the study in the bimatoprost and travoprost groups, respectively. Redness, itching, foreign-body sensation, pain and discomfort were assessed by a questionnaire, and patients were examined for conjunctival hyperemia. Schirmer's I and break-up time tests were performed, and impression cytology of conjunctiva was evaluated.. Subjective symptoms were similar in both groups. The only subjective symptom that changed significantly was redness. The change in conjunctival hyperemia along the study period correlated with the patient-reported redness in both groups, being highest on day 30. Schirmer's test I and break-up time did not change with time and were similar in both groups. The impression cytology grade increased with time in both groups with the only significant difference between groups on day 90 (higher in the bimatoprost group).. We observed conjunctival hyperemia as the most common side effect of bimatoprost and travoprost. Tear film functions were not affected by these drugs while cytological alterations were.

Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Conjunctiva; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Hyperemia; Male; Middle Aged; Ophthalmic Solutions; Prognosis; Risk Factors; Single-Blind Method; Travoprost

Conjunctival hyperaemia and ocular adverse effects induced by a single dose of 0.004% travoprost in healthy subjects were evaluated. A randomized, double-blind cross-over placebo controlled study was done. Conjunctival hyperaemia was evaluated clinically at 12, 24, 36 and 72 hours after dosing and volunteers reported all ocular adverse effects. 15 out of 20 subjects (70%) dosed with travoprost compared with 2 out of 20 (10%) dosed with placebo developed clinically moderate hyperaemia. However, significant difference in hyperaemia in the two groups occurred only at 24 hours (P < 0.048). The hyperaemia cleared by 72 hours. Travoprost may cause significantly short-term conjunctival hyperaemia even after a single dose in the eyes of healthy African subjects.

Topics: Adult; Antihypertensive Agents; Cloprostenol; Conjunctival Diseases; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Follow-Up Studies; Humans; Hyperemia; Male; Nigeria; Ocular Hypertension; Ophthalmic Solutions; Prognosis; Prospective Studies; Reference Values; Risk Factors; Travoprost

To evaluate the quality of 24-hour intraocular pressure (IOP) control between morning- and evening-dosed travoprost in primary open-angle glaucoma patients.. Prospective, crossover, double-masked comparison.. After a 6-week medicine-free period, 33 patients were randomized to receive travoprost dosed in the morning or evening. After 8 weeks of treatment, a 24-hour IOP curve was performed at 6 am, 10 am, 2 pm, 6 pm, 10 pm, and 2 am. Patients were then treated with the opposite dosing regimen for another 8 weeks, after which the 24-hour IOP curve was repeated.. Twenty-four-hour IOP.. The untreated mean 24-hour IOP was 23.6+/-2.0 mmHg. There were no differences for mean 24-hour IOP between the morning (17.5+/-1.9 mmHg) and evening (17.3+/-1.9 mmHg) dosings (P = 0.7). At 10 am, the evening dosing provided a statistically lower IOP (17.2+/-2.1 mmHg) than the morning dosing (19.1+/-2.5 mmHg) (P = 0.02). Evening dosing demonstrated a statistically lower 24-hour fluctuation of IOP (3.2+/-1.0 mmHg) than morning dosing (4.0+/-1.5 mmHg) (P = 0.01). Safety was similar, with conjunctival hyperemia being the most common adverse event (n = 9 [27% for morning dosing] and n = 11 [33% for evening dosing], P = 0.6).. This study suggests that both morning and evening dosings of travoprost provide effective 24-hour IOP reduction. However, the evening dosing of travoprost demonstrates slightly greater daytime efficacy, with a narrower range of 24-hour pressure.

Topics: Circadian Rhythm; Cloprostenol; Conjunctiva; Cross-Over Studies; Double-Blind Method; Drug Administration Schedule; Eye; Glaucoma, Open-Angle; Humans; Hyperemia; Intraocular Pressure; Pruritus; Travoprost; Treatment Outcome

To evaluate conjunctival hyperemia after short-term use of latanoprost 0.005%, bimatoprost 0.03% and travoprost 0.004% in normal adults.. Prospective, randomized, double-masked crossover active controlled comparison.. We evaluated conjunctival hyperemia by a standard photographic measure at the slit lamp and by anterior segment photographs in healthy subjects after dosing for 5 days with latanoprost, bimatoprost, or travoprost. Conjunctival hyperemia was evaluated at 24-hour trough (hour 0) and at hour 1 after dosing. Each subject was crossed over between periods after a 1-week washout interval.. Twenty-eight subjects (mean age 26 +/- 9 years) completed this study. Several comparisons were noted to be significant between groups by slit-lamp biomicroscopy: first, at hour 0 latanoprost had significantly less hyperemia than bimatoprost; second, at hour 0 latanoprost showed significantly less change than bimatoprost compared with the study baseline (visit 2); third, at hour 1 latanoprost had significantly less hyperemia than travoprost; fourth, at hour 1 latanoprost demonstrated significantly less change from baseline in hyperemia than travoprost (visit 2); fifth, at hour 1 latanoprost had less change in hyperemia than bimatoprost or travoprost between the study and the nonstudy eye (P = .03); and last, at hour 1 latanoprost showed significantly less change than bimatoprost and travoprost compared with hour 0 (P = .04). Additionally, similar grades were observed by photographs with latanoprost demonstrating the lowest levels of hyperemia. Subjects complained less about other people noticing their red eye with latanoprost than bimatoprost or travoprost (P = .048). No serious adverse events were noted.. This study suggests that latanoprost may cause significantly less short-term conjunctival hyperemia on average than bimatoprost or travoprost in healthy subjects.

Topics: Adult; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Conjunctiva; Conjunctival Diseases; Cross-Over Studies; Double-Blind Method; Female; Humans; Hyperemia; Intraocular Pressure; Latanoprost; Lipids; Male; Prospective Studies; Prostaglandins F, Synthetic; Time Factors; Travoprost

The VISIONARY study demonstrated statistically significant intraocular pressure (IOP) reductions with the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% (PF tafluprost/timolol FC) in open-angle glaucoma (OAG) or ocular hypertension (OHT) patients, sub-optimally controlled with topical prostaglandin analogue (PGA) or beta-blocker monotherapy. Current subanalyses have examined these data according to the baseline monotherapy.. A European, prospective, observational study included adults (aged ≥ 18 years) with OAG or OHT, who were switched to the PF tafluprost/timolol FC from PGA or beta-blocker monotherapy. Treatment outcomes were reported according to prior monotherapy subgroup: beta-blocker, preserved latanoprost, PF-latanoprost, bimatoprost, tafluprost, and travoprost. Endpoints included the mean change from baseline regarding IOP, conjunctival hyperemia, and corneal fluorescein staining (CFS) at Week 4 and Week 12, and at Month 6.. The subanalysis included 577 patients. All prior monotherapy subgroups demonstrated statistically significant IOP reductions from baseline at Week 4, that were maintained through Month 6 (p < 0.001). Mean (SD) IOP change at Month 6 was 6.6 (4.16), 6.3 (4.39), 5.6 (3.67), 4.9 (2.97), 4.6 (4.39), and 4.7  (3.64) mmHg for prior beta-blocker, preserved latanoprost, PF-latanoprost, tafluprost, bimatoprost, and travoprost subgroups, respectively. The largest IOP change was observed in the preserved latanoprost subgroup for each of the ≥ 20%, ≥ 25%, ≥ 30%, and ≥ 35% IOP reduction categories at Month 6, demonstrating respective reductions of 8.06, 9.20, 10.64, and 11.55 mmHg. CFS was significantly reduced at Month 6 in the prior bimatoprost subgroup (p = 0.0013). Conjunctival hyperemia severity was significantly reduced at each study visit for prior preserved latanoprost users (p < 0.001).. PF tafluprost/timolol FC therapy provided statistically and clinically significant IOP reductions from Week 4 over the total 6-month period, in patients with OAG/OHT, regardless of the type of prior PGA or beta-blocker monotherapy used. Conjunctival hyperemia severity and CFS decreased significantly in prior bimatoprost and preserved latanoprost users, respectively.. European Union electronic Register of Post-Authorization Studies (EU PAS) register number: EUPAS22204.

Topics: Adult; Antihypertensive Agents; Bimatoprost; Drug Combinations; Glaucoma; Glaucoma, Open-Angle; Humans; Hyperemia; Intraocular Pressure; Latanoprost; Ocular Hypertension; Prospective Studies; Prostaglandins A; Prostaglandins F; Timolol; Travoprost

Preservatives in glaucoma medications have been associated with ocular toxicity. We compared ocular signs and symptoms in patients with open-angle glaucoma or ocular hypertension treated in monotherapy with preserved or preservative-free prostaglandin analogues.. Observational cross-sectional clinical study in real life. 82 patients treated for at least 6 months with prostaglandin analogue were assessed for intraocular pressure, ocular symptoms and ocular signs including conjunctival hyperaemia, tear break-up time and tear meniscus height measured using objective and non-invasive methods (OCULUS Keratograph 5M). Patients presenting with symptoms of ocular toxicity with preserved prostaglandin analogues were switched to preservative-free latanoprost, and a second assessment was processed 6 months after.. At inclusion, 30 (36.6%) patients were treated with preservative-free latanoprost, 25 (30.5%) with preserved latanoprost, 16 (19.5%) with preserved travoprost and 11 (13.4%) with preserved bimatoprost. Patients treated with preservative-free latanoprost reported significantly less ocular symptoms upon instillation (mainly burning) and between instillations than patients treated with preserved prostaglandin analogues. The mean conjunctival hyperaemia (limbal + bulbar) was significantly lower with preservative-free latanoprost (2.08 ± 0.55) compared to preserved latanoprost (2.50 ± 0.7, p = 0.0085), preserved travoprost (2.67 ± 0.82, p = 0.0083) and preserved bimatoprost (2.68 ± 0.67, p = 0.0041). There were no relevant between-group differences in mean tear meniscus height and break-up time. Ocular symptoms and conjunctival hyperaemia improved when preserved prostaglandin analogues were switched to preservative-free latanoprost for 6 months while intraocular pressure reduction was maintained.. Overall, this study suggests a better subjective and objective ocular tolerance when patients were treated with preservative-free latanoprost than with other preserved prostaglandin analogues monotherapy. Switching to preservative-free latanoprost maintained intraocular pressure at the same level as preservative prostaglandin analogue, but improved ocular surface tolerance.

Topics: Administration, Ophthalmic; Aged; Aged, 80 and over; Antihypertensive Agents; Bimatoprost; Conjunctival Diseases; Cross-Sectional Studies; Female; Glaucoma, Open-Angle; Humans; Hyperemia; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Preservatives, Pharmaceutical; Prostaglandins, Synthetic; Tonometry, Ocular; Travoprost

Because latanoprost and the original formulation of travoprost that included benzalkonium chloride (BAK) have been shown to be similar with regard to tolerability, we compared initial topical intraocular pressure (IOP)-lowering medication change rates in patients newly treated with latanoprost or travoprost-Z monotherapy.. At 14 clinical practice sites, medical records were abstracted for patients with a diagnosis of open-angle glaucoma or ocular hypertension and who were ≥40 years of age, had a baseline and at least one follow-up visit, and had no prior history of ocular prostaglandin use. Data regarding demographics, ocular/systemic medical histories, clinical variables, therapy initiations and reasons for changes, adverse events, and resource utilization were recorded from randomly chosen eligible charts. Primary outcomes were rates of and reasons for changing from the initial therapy within six months and across the full study period (1000 days).. Data from 900 medical charts (latanoprost, 632; travoprost-Z, 268) were included. For both cohorts, average follow-up was >1 year. Cohorts were similar with regard to age (median ~67 years), gender distribution (>50% female), and diagnosis (~80% with open-angle glaucoma). Within six months, rates of index therapy change for latanoprost versus travoprost-Z were 21.2% (134/632) and 28.7% (77/268), respectively (p = 0.0148); across the full study period, rates were 34.5% (218/632) and 45.2% (121/268), respectively (p = 0.0026). Among those who changed their index therapy, insufficient IOP control was the most commonly reported reason followed by adverse events; hyperemia was the most commonly reported adverse event at index therapy change.. In this "real world" study of changes in therapy in patients prescribed initial monotherapy with latanoprost with BAK or travoprost-Z with SofZia, medication changes were common in both treatment groups but statistically significantly more frequent with travoprost-Z.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Cloprostenol; Cohort Studies; Female; Glaucoma, Open-Angle; Humans; Hyperemia; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Prostaglandins F, Synthetic; Retreatment; Retrospective Studies; 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

To document patient/physician perceptions of adverse effects and their relationship to medication changes among patients prescribed prostaglandin analogs.. Medical/pharmacy claims (private U.S. health network) identified patients filling initial topical ocular hypotensive prescriptions from 2001 to 2004; 300 open-angle glaucoma patients prescribed a prostaglandin analog and 103 ophthalmologists were selected by algorithm for telephone interviews. Medical charts for 225/300 interviewed and 75 non-interviewed patients were abstracted. Medication patterns were assessed in pharmacy claims data. Frequency of adverse effects noted by physicians and associations with medication change decisions were examined in charted data. Patients' experiences with adverse effects were compiled from surveys.. In patients treated with latanoprost (N = 4,071), bimatoprost (N = 1,199), or travoprost (N = 1,001), continuous refill of medication through 1 year was seen in 11%, 9%, and 5% of patients, respectively (P = 0.0001; retrospective pharmacy claims). Adverse effects were the second most common reasons noted by physicians for switching medications after lack of efficacy (19% vs. 43%, respectively). Adverse effects were noted in 65% of patient charts. Hyperemia was the most common adverse effect occurring with at least one other adverse effect in 48% of patients with the condition.. Ocular adverse effects, particularly hyperemia, negatively affect patient continuation with therapy and switching.

Topics: Administration, Topical; Adult; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Databases, Factual; Glaucoma, Open-Angle; Humans; Hyperemia; Latanoprost; Ophthalmic Solutions; Patient Compliance; Pharmaceutical Services; Practice Patterns, Physicians'; Prescription Drugs; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Retrospective Studies; Travoprost

To evaluate intraocular pressure (IOP) control and the ocular adverse effects resulting from a large-scale transition from latanoprost to travoprost among patients at a Veterans Affairs Medical Center (VAMC) Eye Clinic.. Retrospective chart review of patients transitioned from latanoprost to travoprost after a revision of the drug formulary used by the VAMC in Houston, Texas. IOP control after changing medications and the incidence of ocular adverse effects attributed to travoprost were the main outcomes measured. For patients who were using IOP-lowering medications bilaterally, the worse eye was used for all IOP analyses. Long-term retention in IOP control plus a cost-saving analysis were presented as a secondary assessment.. Five hundred ninety-nine (599) patients with 1,041 treated eyes were evaluated. Mean IOP was 15.86 +/- 4.15 mmHg among patients using latanoprost prior to the prostaglandin analog transition. After transitioning to travoprost, the mean IOP was 15.78 +/- 4.38 mmHg. The mean within-eye change in IOP in the worse eye when transitioned from latanoprost to travoprost was -0.07 +/- 3.27 mmHg (P = 0.5914). Twenty-four (24) patients (4%) experienced an ocular adverse effect while using travoprost. In the long-term retention analysis at 1 year, mean change in IOP from the time of the original change to travoprost was +0.21 +/- 3.71 mmHg (P = 0.2683).. The large-scale transition from latanoprost to travoprost maintained long-term IOP control. Only a small percentage of clinic patients experienced mild ocular adverse effects after being transitioned to the new prostaglandin analog.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Cloprostenol; Drug Administration Schedule; Female; Hospitals, Veterans; Humans; Hyperemia; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ophthalmic Solutions; Outpatient Clinics, Hospital; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Retrospective Studies; Travoprost

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