loteprednol-etabonate and Ocular-Hypertension

To perform a systematic evaluation of the efficacy and safety of loteprednol etabonate (LE) 0.5% versus fluorometholone (FML) 0.1% for treating patients after corneal refractive surgery with the aim of providing an evidence-based rationale for clinical drug selection.. Electronic databases (PubMed, EMBASE, Cochrane Library, Web of Science, WanFang, and CNKI) were searched (from inception to December 2021) for comparative clinical studies that evaluated LE versus FML treatment for post-corneal refractive surgery patients. Meta-analysis was performed using the RevMan 5.3 software. The pooled risk ratio (RR) and weighted mean difference (WMD) with corresponding 95% confidence interval (CI) were calculated.. Nine studies with a total sample size of 2677 eyes were included in this analysis. FML 0.1% and LE 0.5% produced a similar incidence of corneal haze within 6 months after surgery (P = 0.13 at 1 month, P = 0.66 at 3 months, and P = 0.12 at 6 months). There was no statistically significant difference between the two groups in terms of the mean logMAR postoperative uncorrected distance visual acuity (WMD: - 0.00; 95% CI: - 0.01 to 0.00; P = 0.29) and spherical equivalent (WMD: 0.01; 95% CI: - 0.01 to 0.03; P = 0.35). LE 0.5% appears to have a higher tendency to reduce the incidence of ocular hypertension compared FML 0.1%, but there was no statistical significance (RR: 0.63; 95% CI: 0.27 to 1.50; P = 0.30).. This meta-analysis demonstrated that LE 0.5% and FML 0.1% had comparable efficacy in preventing corneal haze and corticosteroid-induced ocular hypertension, with no difference in visual acuity in patients after corneal refractive surgery.

Topics: Cornea; Corneal Opacity; Fluorometholone; Humans; Loteprednol Etabonate; Ocular Hypertension; Refractive Surgical Procedures

Corticosteroids are a mainstay therapeutic option for the treatment of ocular inflammation. However, safety remains a concern for clinicians, particularly with long-term use. Though highly effective at suppressing inflammatory and allergic responses, topical ophthalmic corticosteroids carry an inherent risk of side effects, including elevated intraocular pressure (IOP), a risk factor for the development of glaucoma. The corticosteroid loteprednol etabonate (LE) contains an ester rather than a ketone at the C-20 position, minimizing the potential for side effects, including IOP elevation. In early pivotal clinical trials of LE ophthalmic suspension for conjunctivitis (allergic, giant papillary), anterior uveitis, and post-operative inflammation, LE had minimal impact on IOP over short-term (<28 days) and long-term (≥28 days) use. Since then, new LE formulations-including a gel, an ointment, and a suspension of LE in combination with tobramycin-have become commercially available. Multiple studies evaluating the safety and efficacy of LE for inflammatory conditions have been reported, including those requiring longer-term treatment such as photorefractive keratectomy, corneal transplantation, and dry eye disease. We review the available published data on the effect of LE on IOP and report on the cumulative incidence of clinically significant IOP elevations (≥10 mm Hg from baseline) with short-term and long-term LE use. In all studies, LE consistently demonstrated a low propensity to elevate IOP, regardless of formulation, dosage regimen, or treatment duration, including in known steroid responders. The cumulative proportion of patients exhibiting clinically significant IOP increases was 0.8% (14/1725 subjects) in studies evaluating short-term LE treatment and 1.5% (21/1386 subjects) in long-term studies. Furthermore, use of LE was associated with significantly lower rates of IOP elevation ≥10 mm Hg as compared to prednisolone acetate or dexamethasone (when used in combination with tobramycin). The cumulative data to date substantiates a favorable IOP-safety profile for LE with both short-term and long-term use.

Topics: Eye Diseases; Glucocorticoids; Humans; Inflammation; Intraocular Pressure; Long Term Adverse Effects; Loteprednol Etabonate; Ocular Hypertension; Ophthalmic Solutions; Tonometry, Ocular

The continuing development of ophthalmic steroids has resulted in compounds that have a low tendency to raise intraocular pressure (IOP). Preliminary clinical data have suggested that loteprednol etabonate (LE) 0.5% suspension may not elevate IOP while having promise as a potent topical ophthalmic steroid. This study was designed to evaluate the comparative potential of topical LE and prednisolone acetate (PA) to raise IOP in a population of individuals known to be steroid responders. The study used a double-masked, randomized, single eye, crossover design comparing LE 0.5% and PA 1.0%. Subjects instilled 1 drop of the assigned medication 4 times daily while awake, and follow-up examinations occurred on days 14, 28, and 42. Following a washout period of at least 14 days, subjects entered the second phase of the study, which was identical to the first phase, except that subjects received the alternate study medication. The mean IOP in the LE group increased from 17.4mm Hg at baseline to 21.5mm Hg at day 42 (p > 0.05), while in the PA group the mean IOP increased from 18.1mm Hg at baseline to 27.1mm Hg at day 42 (p < 0.05). There were no serious, severe, or clinically significant events in either group, and LE's effect on IOP was differentiable from that of PA. LE has less effect on IOP when compared to the IOP response induced by PA. LE may become a clinically useful ocular steroid with a favorable IOP-safety profile.

Topics: Adolescent; Adult; Aged; Androstadienes; Anti-Inflammatory Agents; Double-Blind Method; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Intraocular Pressure; Loteprednol Etabonate; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prednisolone

To investigate the ocular hypertensive response to topical dexamethasone (DEX), rimexolone (RIM), loteprednol etabonate (LOT) and fluorometholone (FML) in rabbits of different ages.. Seventy-five rabbits of three age groups (7 weeks, 6 months and 1-year old) received topical administration of 0.1% DEX, 1% RIM, 0.5% LOT, 0.1% FML or balanced salt solution four times daily for 1 month. Intraocular pressure (IOP) was monitored at regular time intervals. After a month, eyes were harvested for histological study with haematoxylin and eosin (H&E), periodic acid Schiff and Masson trichrome staining. Trabecular meshwork changes were graded by masked ocular pathologists.. Topical DEX caused the greatest increase in IOP, followed by RIM and FML. LOT caused the least IOP increase. Similar pattern of IOP response to the four corticosteroids was observed in the three studied age groups. Young rabbits (7 week) were the most responsive to corticosteroids among the age groups. Extracellular matrix thickening in the trabecular meshwork region and loss of trabecular meshwork cells were observed after DEX, FML or RIM treatments.. Young rabbits are more susceptible to steroid induced increase in IOP, even for milder steroids such as fluorometholone and rimexolone.

Topics: Administration, Topical; Age Factors; Androstadienes; Animals; Dexamethasone; Disease Models, Animal; Extracellular Matrix Proteins; Fluorometholone; Glucocorticoids; Intraocular Pressure; Loteprednol Etabonate; Male; Ocular Hypertension; Ophthalmic Solutions; Pregnadienes; Rabbits; Tonometry, Ocular; Trabecular Meshwork

The aim of this study was to present a case of a patient who showed a significant increase in intraocular pressure (IOP) with topical administration of loteprednol etabonate 0.2%.. A 29-year-old man administered 1 drop of loteprednol etabonate 0.2% (Alrex(®)) to both eyes 4 times a day for 3 days as an off-label treatment for chronic red eye. By the third day of treatment, IOPs increased to 50 mmHg in each eye. The patient had no previous history of glaucoma. Gonioscopy found open angles in each eye. IOP returned to normal levels after discontinuation of Alrex. Steroid response in the same patient was confirmed on a second trial of Alrex.. Although loteprednol etabonate has been shown to have a minimal effect on IOP in most patients, close follow-up is necessary whenever therapy is initiated.

Topics: Adult; Androstadienes; Anti-Allergic Agents; Antihypertensive Agents; Conjunctivitis, Allergic; Follow-Up Studies; Gonioscopy; Humans; Intraocular Pressure; Loteprednol Etabonate; Male; Ocular Hypertension; Ophthalmic Solutions

Ocular corticosteroids can cause elevations in intraocular pressure (IOP). The purpose of this study was to characterize the timing and severity of IOP elevations in patients receiving loteprednol etabonate 0.5% or loteprednol etabonate 0.5%/tobramycin 0.3%.. A retrospective chart review was conducted at 5 academic and private practices. Any patient who experienced an elevation in IOP ≥5 mm Hg while using loteprednol etabonate or loteprednol etabonate/tobramycin was eligible for inclusion in the study. Data collected included patient demographics, medical and ophthalmic history, concomitant medications, reason for treatment, IOP, and medical and surgical interventions.. Fifty patients experienced IOP elevations after use of topical loteprednol etabonate and were included in the study. The mean (standard deviation [SD]) patient age was 58.8 (20.3) years and 66% were women. The most common reasons for prescribing loteprednol etabonate were dry eye (30%), postoperative therapy (22%), and allergic conjunctivitis (16%). Before treatment, 28% of patients had a history of open-angle glaucoma or ocular hypertension. Mean (SD) IOP before treatment was 15.5 (3.2) mm Hg and increased to a mean (SD) of 24.7 (6.5) mm Hg, a statistically significant increase of 9.2 (SD: 5.8; range: 5-29) mm Hg (P<0.0001). The median duration of treatment with loteprednol etabonate at the time of observed IOP elevation was 55 days (range: 3 days to 3 years). Twenty-four percent of patients required IOP-lowering medications and 8% required surgery to control the elevated IOP.. Alternatives to corticosteroids should be considered when long-term treatment is required for an ocular surface condition.

Topics: Adult; Aged; Androstadienes; Anti-Inflammatory Agents; Cohort Studies; Drug Combinations; Drug Monitoring; Eye Diseases; Female; Glucocorticoids; Humans; Intraocular Pressure; Loteprednol Etabonate; Male; Medical Records; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Retrospective Studies; Severity of Illness Index; Time Factors; Tobramycin

The aim of the present study was to evaluate the frequency of steroid-induced intraocular pressure (IOP) elevation and/or glaucoma in patients with keratoconus (KCN) compared with patients with Fuchs endothelial dystrophy after penetrating keratoplasty (PK).. A retrospective review of the medical records of patients with KCN or Fuchs dystrophy, who underwent PK and were examined on the Cornea Service, Wills Eye Institute, was performed. IOP measurements were recorded preoperatively; postoperative first month and maximal IOP measurements between 1 and 3 months, 4 and 6 months, 7 and 12 months, 1 and 2 years, 2 and 3 years, and 3 and 4 years were noted. Steroid-induced IOP elevation and/or glaucoma were grouped into 5 different categories; an increase in IOP of at least 5 or 10 mm Hg over the preoperative baseline and also IOP > or =22, 30, and 40 mm Hg. Addition of glaucoma medications and/or characteristic glaucomatous optic disc and visual field changes were also assessed.. A total of 100 patients with KCN and 58 patients with Fuchs dystrophy were included in this study. The overall frequency of steroid-induced IOP elevation after PK was 73% in the KCN group and 60.3% in the Fuchs dystrophy group. The frequency of IOP elevation of at least 5 or 10 mm Hg over the preoperative baseline were 72% and 24% in KCN group and 56.9% and 20.7% in the Fuchs dystrophy group, respectively. The frequency of IOP elevation > or =22 or > or =30 mm Hg was 22% and 6% in the KCN group and 29.3% and 1.7% in the Fuchs dystrophy group, respectively. There was one patient in the KCN group who had IOP >40 mm Hg. There was no difference between the groups in terms of frequency of IOP elevation (P > 0.05 for all). Glaucomatous visual field defect was detected in 4 patients in the KCN group and only one patient in the Fuchs dystrophy group. Despite the maximum medical therapy, 2 patients in the KCN group underwent glaucoma surgery and none in the Fuchs dystrophy group.. Steroid-induced IOP elevation or glaucoma after PK is not unusual in eyes with KCN or Fuchs dystrophy. Careful and ongoing observation of IOP throughout the prolonged follow-up period is recommended for these individuals with prompt attention to IOP treatment as indicated.

Topics: Adolescent; Adult; Aged; Androstadienes; Female; Fluorometholone; Fuchs' Endothelial Dystrophy; Glaucoma; Glucocorticoids; Humans; Intraocular Pressure; Keratoconus; Keratoplasty, Penetrating; Loteprednol Etabonate; Male; Middle Aged; Ocular Hypertension; Prednisolone; Retrospective Studies; Risk Factors; Tonometry, Ocular; Young Adult

To describe a clinically observed reduction in intraocular pressure (IOP) without increased allograft rejection in known "steroid responders" using loteprednol etabonate 0.5% ophthalmic suspension as second-line rescue therapy after corneal transplantation.. Medical records from a prespecified 15-month period were retrospectively reviewed for all post-corneal transplant patients in whom loteprednol etabonate was initiated and prednisolone acetate 1.0% ophthalmic suspension withdrawn because of a secondary increase in IOP. Elevated postoperative IOP was defined as IOP that increased > or =21 mm Hg. Baseline IOP values were compared with IOP readings at follow-up examinations, with data points set retrospectively at 0-4, 4-8, 8-16, 16-32, and >32 weeks. Patient records were evaluated for any signs of allograft rejection during loteprednol etabonate therapy.. Thirty patients were found to have switched to loteprednol etabonate after an increase in IOP during postoperative prednisolone acetate treatment. The mean reduction in IOP observed when comparing initial and final values in all 30 patients was 12.9 mm Hg during a mean follow-up of 21.6 weeks. The mean percent reduction in IOP during loteprednol etabonate treatment was 32.6% at 3 weeks and 44.9% at 39 weeks. No clinically observed signs of allograft rejection were documented.. Switching to loteprednol etabonate from prednisolone acetate in known steroid responders was successful in reducing IOP and did not increase the risk of allograft rejection. Because of its lower potential for causing elevated IOP, loteprednol etabonate should be considered in the prophylaxis of allograft rejection in steroid responders.

Topics: Administration, Topical; Adolescent; Adult; Aged; Aged, 80 and over; Androstadienes; Anti-Inflammatory Agents; Child; Child, Preschool; Corneal Transplantation; Drug Administration Schedule; Female; Graft Rejection; Humans; Intraocular Pressure; Loteprednol Etabonate; Male; Middle Aged; Ocular Hypertension; Prednisolone; Retrospective Studies; Salvage Therapy; Young Adult

To validate pharmacologically the feline model of steroid-induced ocular hypertension.. Serial studies were conducted in domesticated adult female cats trained to accept topical ocular drug administration and pneumotonometry. To establish intraocular pressure (IOP) values for each study, measurements were performed at the same time of day for 6 consecutive days. Beginning on day 7, cats received either steroid or vehicle administered topically to both eyes three times a day for approximately 28 days. The IOP measurements were performed daily.. After 5 to 7 days of treatment with 0.1% dexamethasone or 1.0% prednisolone acetate, IOP began to increase, reaching peak values within 2 weeks. These values were sustained throughout dosing but declined rapidly to baseline upon cessation of treatment. Maximum IOPs for the dexamethasone- and prednisolone-treated groups averaged 4.5 +/- 0.3 mm Hg (n = 12) greater than the mean IOP value obtained in vehicle-treated cats. Cats treated with 0.25% fluorometholone, 1.0% loteprednol etabonate, and 1.0% rimexolone exhibited increases of 0.6, 1.2, and 1.7 mm Hg, respectively. These values were significantly lower than those observed following treatment with dexamethasone or prednisolone.. The ocular hypertensive effects of selected anti-inflammatory topical ocular steroids in this model are consistent with clinical findings.. This feline model is a useful tool for assessing the potential IOP liability of novel anti-inflammatory steroids.

Topics: Administration, Topical; Androstadienes; Animals; Cats; Dexamethasone; Disease Models, Animal; Female; Fluorometholone; Glucocorticoids; Humans; Intraocular Pressure; Loteprednol Etabonate; Ocular Hypertension; Ophthalmic Solutions; Prednisolone; Pregnadienes; Random Allocation; Reproducibility of Results; Tonometry, Ocular