Comparing Generic and Brand Bimatoprost Eye Drops for Treating Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes A Randomized, Double-blind, Multiple Dose, Multicenter Study

What this Trial Is About

Researchers are evaluating the bioequivalence of two eye drop treatments for adults with chronic open-angle glaucoma or ocular hypertension in both eyes. This randomized, double-blind, parallel-group clinical trial aims to compare a generic bimatoprost ophthalmic solution 0.01% with the branded LUMIGAN4 bimatoprost ophthalmic solution 0.01%. The study focuses on measuring changes in intraocular pressure IOP at specific times after dosing and monitoring safety through adverse event reports. Participants will be randomly assigned to receive either the test product or the reference product, each administered as one drop in both eyes every night at 1000 pm plus or minus one hour for 42 days 6 weeks. Before starting treatment, subjects will undergo a washout period of 4 days to 4 weeks depending on their prior medications. The treatment groups will have nearly equal numbers of participants based on baseline IOP and corneal thickness measurements. During the study, participants will have their IOP measured at 0000, 0400, and 0800 hours on Day 14 and Day 42 visits. Researchers will monitor safety by recording and analyzing any adverse events throughout the 6-week treatment period. The total participation includes screening, washout, treatment administration, and safety monitoring to assess the similarity and tolerability of the two bimatoprost eye drops.

A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes