Pilot Trial of Loteprednol Etabonate Gel 0.5% at BID Dosing in Cataract Surgery Patients
Narrative Responses:
Purpose
The objective for this study was to evaluate the efficacy of the loteprednol etabonate 0.5% gel formulation administered BID to control pain and inflammation in post cataract patients.
Methods
This study was a 4-week, 3 Visit (Postop Day 1, Week 1, and Week 4) prospective, single-center, single-arm, open-label clinical trial in cataract patients. Patients scheduled for routine cataract surgery (grades 1-3) were eligible for inclusion in the study. Patients were excluded from the study if they could not afford the study medications. Crystalens patients were also excluded. Loteprednol etabonate gel 0.5% was instilled BID 2 days prior to surgery and BID for 4 weeks after surgery. Anterior chamber inflammation (cell; 0-5 scale), intraocular pressure (IOP) and pain/discomfort were evaluated as endpoints.
Results
Forty-two (42) subjects completed the study, and 53 eyes were evaluated. Mean cell scores (standard deviation) were 1.6 (1.3), 0.6 (0.8), and 0.1 (0.3) for visits 1, 2, and 3, respectively. Mean IOP scores (standard deviation) were 17.1 (5.0), 13.8 (2.5), and 13.7 (2.6) for visits 1, 2, and 3, respectively. No intraocular pressure spikes were recorded. Three patients reported pain/discomfort at Visit 1, 5 at Visit 2 and 4 patients at Visit 3. All patients reported that the loteprednol etabonate 0.5% gel formulation was comfortable.
Conclusion
Administration of loteprednol etabonate 0.5% gel BID for 2 days prior to surgery and BID for 4 weeks after surgery was effective for the control of pain and inflammation associated with cataract surgery in this pilot trial.