loteprednol-etabonate and Postoperative-Complications

Loteprednol etabonate ophthalmic gel 0.38% (Lotemax

Topics: Anti-Allergic Agents; Cataract Extraction; Gels; Humans; Inflammation; Intraocular Pressure; Loteprednol Etabonate; Pain, Postoperative; Postoperative Complications; Randomized Controlled Trials as Topic; Visual Acuity

Loteprednol etabonate ophthalmic gel 0.5% (Lotemax(®)) is approved in the USA for the treatment of post-operative inflammation and pain in patients who have undergone ocular surgery. The new gel formulation of loteprednol etabonate offers some potential advantages over the previously available ophthalmic suspension and ointment formulations of the drug. Because the gel is non-settling, a uniform dose of loteprednol etabonate is delivered without the need to vigorously shake the product. The pH of the gel formulation is close to that of physiological tears and the concentration of preservative is low. In clinical trials, loteprednol etabonate ophthalmic gel 0.5% for 14 days was effective, very well tolerated and safe when used for the treatment of post-operative inflammation and pain following cataract surgery. Relative to vehicle, loteprednol etabonate ophthalmic gel 0.5% effectively reduced postoperative ocular inflammation and ocular pain and had a similar overall tolerability, comfort and safety profile. It is associated with a low risk of inducing clinically significant increases in intraocular pressure. In conclusion, loteprednol etabonate ophthalmic gel 0.5% is an additional formulation option for the short-term treatment of post-operative inflammation and pain in patients who have undergone ocular surgery. It provides uniform dosing of a topical ophthalmic corticosteroid that has been demonstrated to be effective and well-tolerated in the treatment of ocular inflammation.

Topics: Administration, Ophthalmic; Androstadienes; Chemistry, Pharmaceutical; Gels; Humans; Inflammation; Loteprednol Etabonate; Pain; Postoperative Complications; Postoperative Period

Topical corticosteroids are routinely used as postoperative ocular anti-inflammatory drugs; however, adverse effects such as increased intraocular pressure (IOP) are observed with their use. While older corticosteroids such as dexamethasone and prednisolone acetate offer good anti-inflammatory efficacy, clinically significant increases in IOP (≥10 mmHg) are often associated with their use. Loteprednol etabonate, a novel C-20 ester-based corticosteroid, was retrometabolically designed to offer potent anti-inflammatory efficacy but with decreased impact on IOP. After exerting its therapeutic effects on the site of action, loteprednol etabonate is rapidly converted to inactive metabolites, resulting in fewer adverse effects. Randomized controlled studies have demonstrated the clinical efficacy and safety of loteprednol etabonate ophthalmic suspension 0.5 % for the treatment of postoperative inflammation in post-cataract patients with few patients, if any, exhibiting clinically significant increases (≥10 mmHg) in IOP. Furthermore, safety studies demonstrated a minimal effect of loteprednol etabonate on IOP with long-term use or in steroid responders with a much lower propensity to increase IOP relative to prednisolone acetate or dexamethasone. The anti-inflammatory treatment effect of loteprednol etabonate appears to be similar to that of rimexolone and difluprednate with less impact on IOP compared to difluprednate, although confirmatory comparative studies are needed. The available clinical data suggest that loteprednol etabonate is an efficacious and safe corticosteroid for the treatment of postoperative inflammation.

Topics: Androstadienes; Animals; Anti-Allergic Agents; Dose-Response Relationship, Drug; Humans; Loteprednol Etabonate; Postoperative Complications; Suspensions; Uveitis, Anterior; Wound Healing

Ocular inflammatory diseases impose a significant medical and economic burden on society. Corticosteroids are potent anti-inflammatory agents that have been used successfully to treat ocular inflammation. Topical corticosteroids provide maximal drug delivery, and are used to reduce the signs and symptoms of intraocular and ocular surface inflammation. However, side effects associated with topical corticosteroids-including increased intraocular pressure, risk of cataract formation after long-term use, and decreased resistance to infection-are concerns. Loteprednol etabonate (LE) is an ester corticosteroid with a high therapeutic index that contains an ester, rather than a ketone, at carbon-20 of the prednisolone core structure. LE blocks the release and action of inflammatory mediators and is clinically effective in the treatment of steroid-responsive inflammatory conditions including giant papillary conjunctivitis, seasonal (intermittent) allergic conjunctivitis and uveitis. LE relieves ocular surface and lacrimal gland inflammation associated with dry eye and is used in combination with ciclosporin A as a treatment of dry eye. LE is also effective in the treatment of postoperative ocular inflammation. Because of its rapid de-esterification to inactive metabolites, LE appears to have an improved safety profile compared with ketone corticosteroids, and may be more suitable than ketone corticosteroids for the treatment for ocular inflammatory conditions in which long-term therapy is necessary. However, further comparative safety studies are needed.

Topics: Androstadienes; Anti-Inflammatory Agents; Conjunctivitis; Conjunctivitis, Allergic; Dry Eye Syndromes; Endophthalmitis; Humans; Loteprednol Etabonate; Postoperative Complications; Uveitis, Anterior

To compare loteprednol etabonate (LE) gel 0.5% with prednisolone acetate suspension (PA) 1% for the treatment of inflammation after cataract surgery in children.. Eleven sites in the United States.. Randomized, double-masked, parallel-group, noninferiority study.. Eligible patients were aged 11 years or younger and candidates for routine, uncomplicated cataract surgery. Patients were randomized to a 4-week postsurgical regimen with LE gel 0.5% or PA 1%, twice on the day of surgery, 4 times daily for 2 weeks, twice daily for 1 week, and once daily for 1 week. Assessments included anterior chamber (AC) cells/flare, anterior chamber inflammation (ACI), synechiae, precipitates on the intraocular lens/cornea, visual acuity, and intraocular pressure.. The intent-to-treat population comprised 105 patients (LE gel, n = 53; PA 1%, n = 52) including 52 patients aged 3 years or younger. Patients achieved a similar mean ACI grade on postoperative day 14 (primary efficacy endpoint) whether treated with LE gel 0.5% or PA 1% (difference = 0.006, 2-sided 95% CI, -0.281 to 0.292). Similar ACI outcomes additionally were observed in patients aged 3 years or younger. LE gel 0.5% and PA 1% also appeared equally effective in resolving inflammation at all visits (days 7, 14, and 28 postsurgery), based on categorical distributions of ACI, AC cells, and AC flare scores/grades (P ≥ .06). Synechiae and corneal/IOL precipitates occurred infrequently with no significant differences between groups. No safety or tolerability concerns were identified, including no treatment-related IOP increases.. LE gel 0.5% was safe and effective in treating pediatric postcataract surgical inflammation, with similar outcomes as PA 1%.

Topics: Androstadienes; Cataract; Child; Double-Blind Method; Humans; Inflammation; Intraocular Pressure; Loteprednol Etabonate; Ophthalmic Solutions; Postoperative Complications; Prednisolone

To compare the efficacy and safety of postoperative topical loteprednol etabonate (LE) 0.5% with dexamethasone (DEX) 0.1% for the treatment of inflammation following pars plana vitrectomy (PPV).. A total of 150 eyes of 150 patients who underwent transconjunctival PPV for various diagnoses were included in this prospective, randomized study. The patients were assigned into two groups as Group LE (n = 75) and Group DEX (n = 75). Intraocular inflammation, intraocular pressure (IOP), and the intensity of postoperative pain were compared between the groups.. The mean IOP was higher in the patients treated with DEX (p > 0.05). The need for anti-glaucoma medications was significantly lower in Group LE (5.3%) than in Group DEX (17.3%) (p = 0.020). Tyndall scores were less in Group DEX at postoperative Days 1 (p = 0.01) and 3 (p = 0.017). On Day 1, it was more likely for patients to have mild or moderate pain in Group LE (p < 0.001). On Day 3, the number of the patients with no pain was higher in Group DEX (p = 0.005).. Although DEX is more effective in the early postoperative days, LE appears to be as effective in controlling inflammatory response following PPV in the long-term. Topical LE is associated with less increase in the IOP and a lower need for anti-glaucoma medications.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anti-Allergic Agents; Child; Double-Blind Method; Female; Follow-Up Studies; Humans; Loteprednol Etabonate; Male; Middle Aged; Ophthalmic Solutions; Postoperative Complications; Prospective Studies; Treatment Outcome; Uveitis; Vitrectomy; Young Adult

We aimed to evaluate the safety and effectiveness of 2 dosing regimens of loteprednol etabonate (LE) ophthalmic gel 0.5% and bromfenac ophthalmic solution 0.07% in patients undergoing routine cataract surgery.. Six-week prospective, masked, randomized controlled noninferiority study.. One hundred eyes.. Patients undergoing uncomplicated cataract surgery were selected in a consecutive manner. Patients were randomized to one of 2 groups: LE QID + qD bromfenac (control group) versus LE BID + qD bromfenac (study group). Primary outcome metrics included summed ocular inflammation score (SOIS) and adverse events. Secondary outcome measures included intraocular pressure, visual acuity, central retinal thickness, and subjective symptomology scores measured at 4 study visits. The final visit included a questionnaire addressing compliance, satisfaction, and comfort with the medications.. Both groups demonstrated similar effectiveness and safety between dosing regimens. No statistically significant difference was reported between groups regarding SOIS (visit 1 p = N/A, visit 2 p = 0.66, visit 3 p = 0.60, visit 4 p = 0.08). No adverse events were reported relating to the difference in study regimen. A statistically significant difference was not found regarding secondary outcomes (p > 0.05). Control group patients reported a more difficult time remembering their doses for bromfenac but not LE (bromfenac p < 0.05; LE p = 0.15).. Our data suggest that both groups had similar outcomes with respect to control of ocular inflammation with no differences in adverse outcomes. The compliance questionnaire also suggests a patient preference for the dosing regimen with lower frequency of drop application.

Topics: Aged; Anti-Allergic Agents; Anti-Inflammatory Agents, Non-Steroidal; Benzophenones; Bromobenzenes; Cataract Extraction; Dose-Response Relationship, Drug; Double-Blind Method; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Intraocular Pressure; Intraoperative Period; Loteprednol Etabonate; Male; Ophthalmic Solutions; Patient Satisfaction; Postoperative Complications; Prospective Studies; Time Factors; Treatment Outcome; Visual Acuity

To assess the safety and efficacy of a 0.38% submicron formulation of loteprednol etabonate (LE) gel for the treatment of postoperative inflammation and pain after cataract surgery.. Forty-five United States ophthalmology practices.. Double-masked vehicle-controlled randomized parallel group study.. Patients 18 years of age or older with anterior chamber cells grade 2 or higher on day 1 after uncomplicated cataract surgery were randomized to 14 days of treatment with LE gel 2 times a day, LE gel 3 times a day, or vehicle. Hierarchical primary endpoints were the proportion of patients with resolution of anterior chamber cells and grade 0 (no) pain at postoperative day 8. Safety outcomes included adverse events, intraocular pressure (IOP), biomicroscopy, visual acuity, ophthalmoscopy, and tolerability (drop comfort and ocular symptoms).. The intent-to-treat population included 514 patients. Significantly more patients in the LE gel 2 times a day and 3 times a day groups compared with the vehicle group had complete resolution of anterior chamber cells (26.9% and 28.7% versus 9.3%) and reported grade 0 pain (73.7% and 73.1% versus 47.7%) on day 8 (P < .001 vs vehicle for all). The safety findings were unremarkable, with 1 patient experiencing an IOP increase of 10 mm Hg or higher while on LE gel. More than 75% of patients in each group reported no drop discomfort.. In this study, submicron loteprednol etabonate gel 0.38% appeared safe and effective in the treatment of postoperative inflammation and pain whether instilled 2 times or 3 times a day.

Topics: Adult; Aged; Aged, 80 and over; Anti-Allergic Agents; Double-Blind Method; Eye Pain; Female; Gels; Humans; Inflammation; Intraocular Pressure; Loteprednol Etabonate; Male; Microscopy, Acoustic; Middle Aged; Ophthalmoscopy; Phacoemulsification; Postoperative Complications; Treatment Outcome; Visual Acuity

We aimed to evaluate the safety and efficacy of loteprednol etabonate (LE) gel 0.5% compared with vehicle in the treatment of postoperative inflammation and pain following cataract surgery, using the integrated analysis of data from two identical, prospective, multicenter, randomized, double-masked, parallel-group, vehicle-controlled trials.. Patients with anterior chamber cell (ACC) inflammation ≥ grade 2 (6-15 cells) 1 day post-surgery were randomized to receive 1 or 2 drops of LE gel 0.5% or vehicle 4 times per day instilled in the study eye for 14 days. Primary outcome measures included the proportion of patients with complete resolution of ACC and grade 0 (no) pain on postoperative Day 8. Safety endpoints included adverse events (AEs), changes from baseline in intraocular pressure (IOP) and visual acuity (VA), biomicroscopy, and funduscopy findings. Gel comfort was graded by patients according to drop sensation.. The intent-to-treat population included 813 patients (409 LE gel 0.5% and 404 vehicle). At postoperative Day 8, 30.8% and 15.1% of patients randomized to LE gel 0.5% or vehicle, respectively, had complete resolution of ACC, while 74.3% and 43.8% of patients, respectively, had grade 0 pain (P < 0.001 for both). Tolerability assessments for ocular itching, photophobia, and tearing favored LE gel 0.5% compared with vehicle at different time points beginning at Day 3. Two patients in the LE gel 0.5% group and 1 patient in the vehicle group exhibited a transient treatment-emergent increase in IOP ≥ 10 mmHg. Treatment-related AEs were generally mild to moderate and occurred less frequently with LE gel 0.5% than with vehicle. Reports of treatment-related blurred vision were rare (n = 2, vehicle).. LE gel 0.5% was efficacious and well tolerated in the treatment of postoperative pain and inflammation following ocular surgery, with minimal risk of IOP elevation.

Topics: Administration, Ophthalmic; Adult; Aged; Aged, 80 and over; Androstadienes; Anterior Chamber; Anti-Inflammatory Agents; Cataract Extraction; Double-Blind Method; Female; Gels; Humans; Inflammation; Loteprednol Etabonate; Male; Middle Aged; Pain, Postoperative; Postoperative Complications; Treatment Outcome

To examine the efficacy and safety of a new gel formulation loteprednol etabonate 0.5% in the treatment of inflammation and pain after cataract surgery.. Seventeen United States clinical sites.. Prospective double-masked parallel-group study.. Patients with anterior chamber cell (ACC) grade 2 or higher after cataract surgery were randomized to loteprednol etabonate 0.5% gel or vehicle 4 times a day for 14 days. Primary outcome measures included the proportion of patients with complete resolution of ACC and grade 0 (no) pain on postoperative day 8. Safety measures included adverse events, intraocular pressure (IOP), visual acuity, biomicroscopy and funduscopy findings, and tolerability (ocular symptoms and drop comfort).. The intent-to-treat population included 406 patients (203 per treatment). On day 8, 30.5% of patients in the loteprednol etabonate group and 16.3% of patients in the vehicle group had complete resolution of ACC, whereas 72.9% and 41.9%, respectively, had grade 0 pain (both P<.001). Significant treatment differences for complete resolution of ACC and grade 0 pain favoring loteprednol etabonate were also found on day 15 and day 18. One patient in each treatment group had a significant increase in IOP (≥ 10 mm Hg). Analyses of pain, photophobia, and tearing favored loteprednol etabonate at different time points beginning on day 3. More than 85% of patients in each treatment group reported no discomfort on drop instillation.. Loteprednol etabonate gel 0.5% was efficacious and safe in treating postoperative inflammation and pain.. Dr. Rajpal is a consultant to Bausch & Lomb, Inc., Allergan, Inc., and Alcon Laboratories, Inc. Dr. Siou-Mermet and Ms. Erb are employees of Bausch & Lomb, Inc. Dr. Roel has no financial or proprietary interest in any material or method mentioned.

Topics: Adult; Aged; Aged, 80 and over; Androstadienes; Anterior Chamber; Anti-Allergic Agents; Cataract Extraction; Double-Blind Method; Eye Pain; Female; Gels; Humans; Inflammation; Intraocular Pressure; Loteprednol Etabonate; Male; Microscopy, Acoustic; Middle Aged; Ophthalmoscopes; Postoperative Complications; Treatment Outcome; Uveitis, Anterior; Visual Acuity

To evaluate the efficacy of loteprednol etabonate 0.5% versus prednisolone acetate 1.0% for the control of postoperative inflammation in patients having routine cataract surgery.. Private practice, Stillwater, Minnesota, and Cincinnati Eye Institute, Cincinnati, Ohio, USA.. Comparative case series.. Patients were at least 18 years of age and scheduled for routine cataract surgery. Patients were excluded from the study if they had preexisting medical conditions (ie, elevated intraocular pressure [IOP], retinopathy, maculopathy, uveitis) or required medications the investigator believed would put the patient at risk or confound the study. Patients were randomized to receive loteprednol etabonate or prednisolone acetate 4 times daily in addition to bromfenac 0.09% and besifloxacin 0.6% after surgery. Visual acuity, IOP, and anterior chamber cell and flare intensity were assessed over 3 weeks after cataract surgery. The primary endpoint was the level of anterior chamber cell and flare intensity in patients treated with loteprednol etabonate or prednisolone acetate.. The study enrolled 88 patients (46 loteprednol etabonate, 42 prednisolone acetate). Equivalency was achieved between the 2 treatment groups with no significant differences throughout the 3-week follow-up. There was less fluctuation in IOP assessments in patients treated with loteprednol etabonate than in patients treated with prednisolone acetate, in particular 1 day and 3 days postoperatively.. The results indicate that equivalent control of inflammation can be obtained through treatment with loteprednol etabonate or prednisolone acetate after cataract surgery. In addition, treatment with loteprednol etabonate may result in less IOP fluctuation.. Dr. Lane is a consultant to Bausch & Lomb, Rochester, New York, Alcon Laboratories, Inc., Fort Worth, Texas, and ISTA Pharmaceuticals, Irvine, California, USA. Dr. Holland is a consultant to Bausch & Lomb, Rochester, New York, and Alcon Laboratories, Inc., Fort Worth, Texas, USA. Neither author has a financial or proprietary interest in any material or method mentioned.

Topics: Adult; Aged; Aged, 80 and over; Androstadienes; Anterior Chamber; Anti-Allergic Agents; Anti-Inflammatory Agents, Non-Steroidal; Azepines; Benzophenones; Bromobenzenes; Cataract Extraction; Double-Blind Method; Drug Therapy, Combination; Female; Fluoroquinolones; Glucocorticoids; Humans; Inflammation; Intraocular Pressure; Loteprednol Etabonate; Male; Middle Aged; Ophthalmic Solutions; Postoperative Complications; Prednisolone; Topoisomerase II Inhibitors; Uveitis, Anterior; Visual Acuity

To compare the efficacy of a topical nonsteroidal antiinflammatory agent (ketorolac tromethamine ophthalmic solution 0.5%) and a topical steroid (loteprednol etabonate ophthalmic suspension 0.5%) in controlling inflammation after cataract surgery.. Magill Research Center for Vision Correction, Storm Eye Institute, Medical University of South Carolina, Charleston, South Carolina, USA.. Sixty patients were prospectively and randomly assigned to receive topical treatment with ketorolac tromethamine ophthalmic solution 0.5% or loteprednol etabonate ophthalmic suspension 0.5% starting the day after routine phacoemulsification for cataract extraction. Both patient and investigator were masked to treatment. All patients had uneventful small-incision phacoemulsification with placement of a foldable posterior chamber intraocular lens (IOL). Patients used 1 of the 2 antiinflammatory agents 4 times a day starting 24 hours after surgery. Signs and symptoms of inflammation as documented by external slitlamp examination, intraocular pressure (IOP), and Kowa cell and flare measurements were evaluated on postoperative days 1, 4, 7, and 30.. There was no statistically significant difference in any measurement of postoperative inflammation between the 2 groups. There was no difference in objective or subjective cell and flare measurements or in IOP between groups. No patient in either group was removed from the study for lack of treatment efficiency.. Ketorolac tromethamine ophthalmic solution 0.5% was as effective as loteprednol etabonate ophthalmic suspension 0.5% in reducing inflammation after routine phacoemulsification and IOL implantation. These results suggest that ketorolac tromethamine 0.5% is a safe and effective antiinflammatory alternative to steroids after cataract extraction.

Topics: Aged; Androstadienes; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Double-Blind Method; Female; Foreign-Body Reaction; Humans; Intraocular Pressure; Ketorolac Tromethamine; Lens Implantation, Intraocular; Loteprednol Etabonate; Male; Ophthalmic Solutions; Phacoemulsification; Postoperative Complications; Prospective Studies; Safety; Treatment Outcome; Uveitis, Anterior

This study aimed to compare the efficacy and safety of loteprednol etabonate (LE) 0.5% to placebo (vehicle) in controlling the anterior chamber cell and flare reaction in patients undergoing cataract surgery with intraocular lens (IOL) implantation.. Randomized, double-masked, placebo-controlled, parallel group multicenter study.. A total of 203 patients undergoing elective cataract removal and posterior chamber intraocular lens implantation who, on the day after surgery, exhibited a minimum anterior chamber inflammation score (ACI, sum of cell and flare reaction) rating of 3 (0-9 scale).. All patients received either LE 0.5% or placebo (vehicle) four times daily in the eye that was operated on for up to 14 days after surgery.. Resolution of ACI by final, on-treatment visit was measured.. The proportion of patients with ACI resolved by the final visit was 56 (55%) of 102 in the LE group and 28 (28%) of 100 in the placebo group (P < 0.001). For all the individual components of ACI (cell and flare), as well as other signs and symptoms, the resolution rate and mean change from baseline favored LE. Expanding the efficacy criterion to include patients with mild inflammation at final visit, the efficacy of LE was 95 (93%) of 102 in contrast to 65 (65%) of 100 for placebo. Among the 39 patients who did not complete the study, the majority were discontinued for inadequate anti-inflammatory effect: 25 (25%) of 101 placebo patients and 5 (5%) of 102 of LE patients. The difference in the treatment failure rates, as well the difference in the time course of failures, was both clinically meaningful and statistically significant in favor of LE (P < 0.001). Both treatments were well-tolerated. No clinically significant elevations in intraocular pressure (> or = 10 mmHg) were seen in the LE treatment group. One patient in the placebo treatment group met this criterion.. Loteprednol etabonate showed a clinically meaningful reduction in the signs and symptoms of postoperative anterior chamber inflammation when compared with that of placebo and had an acceptable safety profile compared with placebo.

Topics: Adult; Aged; Aged, 80 and over; Androstadienes; Anterior Chamber; Anti-Inflammatory Agents; Cataract Extraction; Double-Blind Method; Drug Evaluation; Female; Humans; Inflammation; Lens Implantation, Intraocular; Loteprednol Etabonate; Male; Middle Aged; Ophthalmic Solutions; Postoperative Complications; Prospective Studies; Safety; Uveitis, Anterior

To compare the efficacy and safety of loteprednol etabonate 0.5% with those of a placebo (vehicle) in controlling anterior chamber cell and flare reaction in patients having cataract surgery with intraocular lens (IOL) implantation.. This randomized, double-masked, placebo-controlled, parallel-group multicenter study comprised patients who exhibited a minimum anterior chamber inflammation (ACI) score (sum of cell and flare reaction) of 3 (0 to 9 scale) on the day after cataract removal with posterior chamber IOL implantation. All 227 patients received loteprednol etabonate 0.5% or the placebo 4 times a day in the operated eye for up to 14 days after surgery. Five patients without valid on-treatment follow-up visits were not evaluated for efficacy.. By the final visit, the ACI had resolved in 64% (70/109) of patients in the loteprednol etabonate group and 29% (33/113) of those in the placebo group (P < .001). The resolution rate and mean change from baseline of the individual components of ACI (cell and flare), as well as other signs and symptoms, was better in the loteprednol etabonate group. Both treatments were well tolerated. Among the 53 patients who did not complete the study, 34 (29%) were placebo patients discontinued for inadequate anti-inflammatory effect. The treatment failure rate and the time course of failures were lower in the loteprednol etabonate group; the differences were clinically meaningful and statistically significant (P < .001). Three patients in the loteprednol etabonate group had an intraocular pressure elevation of 10 mm Hg or more over the preoperative screening value.. Loteprednol etabonate 0.5% led to a clinically meaningful reduction in the signs and symptoms of postoperative ACI and had an acceptable safety profile when compared with a placebo.

Topics: Adult; Aged; Aged, 80 and over; Androstadienes; Anterior Chamber; Anti-Inflammatory Agents; Cataract Extraction; Cell Count; Double-Blind Method; Female; Humans; Intraocular Pressure; Lens Implantation, Intraocular; Loteprednol Etabonate; Male; Middle Aged; Ophthalmic Solutions; Postoperative Complications; Safety; Uveitis, Anterior

Topical ophthalmic corticosteroids are of clinical benefit in the management of pain and inflammation after ocular surgery; however, their use can be associated with class-associated adverse events (AEs) and limited bioavailability. Selection of an appropriate topical corticosteroid depends on drug-specific variables such as AE profile, efficacy, potency, dosing, patient-specific administration needs, and formulation properties aimed at minimizing precorneal drug loss, increasing ocular surface drug residence time, and maximizing drug delivery to the anterior tissues. Recently, strategies for improving ocular penetration of ophthalmic formulations have included use of mucoadhesive formulations (ie, polycarbophil-containing gels) and drug particle size reduction, enabling faster drug dissolution and therefore increased bioavailability and penetration. Loteprednol etabonate (LE) is a carbon-20 ester corticosteroid developed through retrometabolic drug design with potent anti-inflammatory effects and a reduced propensity for eliciting corticosteroid class AEs. This drug has been formulated for topical ophthalmic use after surgery as 0.5% and 1% suspensions, a 0.5% ointment, and a 0.5% gel. Preclinical and clinical data for a new 0.38% LE gel will be reviewed demonstrating that reducing the drug particle size to the nanometer range in diameter provides effective ocular tissue penetration and resolution of pain and inflammation despite a reduced drug concentration (0.38%) and dosing frequency.

Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Anti-Allergic Agents; Eye Diseases; Eye Pain; Female; Humans; Inflammation; Loteprednol Etabonate; Male; Middle Aged; Ophthalmic Solutions; Postoperative Complications; United States

To compare the outcomes and complications of topical difluprednate 0.05% and loteprednol gel 0.5% after routine cataract surgery.. Subjects received either difluprednate emulsion 0.05% (n=30 eyes) or loteprednol gel 0.5% (n=30 eyes) after routine cataract surgery. Topical steroid drops were initiated 3 days before cataract surgery and continued for 2 weeks postoperatively. Anterior chamber (AC) cell grade, corneal edema, corneal pachymetry, visual acuity, ocular surface quality (Oxford scale), and intraocular pressure (IOP) were evaluated at 1 day, 1 week, and 1 month postoperatively.. Patients treated with difluprednate or loteprednol had statistically similar resolution of their AC cell grade and corneal edema at 1 day, 1 week, and 1 month postoperatively (P>0.05 at each study visit). Difluprednate-treated and loteprednol-treated eyes achieved a mean best-corrected visual acuity of at least 20/25 by 1 week postoperatively (0.055 and 0.061 logarithm of the minimum angle of resolution, respectively; P=0.82). The nasal ocular surface quality at 1 week had improved in loteprednol-treated eyes compared with difluprednate-treated eyes (1.0 vs. 1.9 Oxford score, respectively; P<0.001), but similar at all other visits. There was no statistical difference between IOP levels between both treatment groups (P>0.05). In the difluprednate-treated group, one patient developed rebound inflammation and two patients developed cystoid macular edema at their 1-month postoperative visit.. The anti-inflammatory effect, visual recovery, and IOP of patients using topical difluprednate or loteprednol gel after cataract surgery are equivalent. There may be an additional short-term benefit of loteprednol gel in protecting the ocular surface after cataract surgery.

Topics: Aged; Aged, 80 and over; Anterior Chamber; Anti-Inflammatory Agents; Cataract Extraction; Cornea; Corneal Edema; Eye Diseases; Female; Fluprednisolone; Gels; Glucocorticoids; Humans; Inflammation; Intraocular Pressure; Loteprednol Etabonate; Male; Middle Aged; Postoperative Complications; Visual Acuity

To review cases of central toxic keratopathy (CTK) occurring over a period of 46 days.. Moorfields Eye Hospital, London, United Kingdom.. Retrospective consecutive case series.. This was a review of patients with CTK after uneventful laser in situ keratomileusis (LASIK) performed by 1 of 5 surgeons at a single institute. The following parameters were analyzed: corrected distance visual acuity (CDVA), manifest refraction, and central corneal thickness from Scheimpflug pachymetry readings (Pentacam).. The cohort consisted of 15 eyes of 9 patients. Thirteen eyes were diagnosed within 7 days after LASIK, while the remaining 2 eyes developed CTK 12 days postoperatively. In 10 eyes, the time to resolution was 1 to 8 months. Five eyes still had residual signs at the last outpatient visit. At the final follow-up, 3 eyes (20%) had a CDVA worse than 0.0 logMAR.. Although a rare entity, CTK can occur in clusters. Although a cause was not fully isolated, ultimately each eye achieved excellent CDVA (all better than 0.2 logMAR) at the last follow-up.

Topics: Adult; Androstadienes; Anti-Allergic Agents; Corneal Stroma; Corneal Topography; Humans; Hyperopia; Keratitis; Keratomileusis, Laser In Situ; Lasers, Excimer; Loteprednol Etabonate; Male; Microscopy, Confocal; Myopia; Postoperative Complications; Refraction, Ocular; Retrospective Studies; Surgical Flaps; Visual Acuity