NCT04890106

Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% to LUMIGAN® In The Treatment of Chronic Open-Angle Glaucoma

A Randomized ( 1:1), Double-Masked, Multi-Center, Two-Treatment, Single-Period, Parallel Design, Mutiple Dose Bioequivalence Study With Clinical End-Point of Bimatoprost Ophthalmic Solution 0.01% of Mankind Pharma Limited With LUMIGAN (Bimatoprost Ophthalmic Solution) 0.01% of Allergan, Inc., in Subjects With Chronic Open-Angle Glaucoma Or Ocular Hypertension in Both Eyes

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 310 (actual)
• Sponsor: Mankind Pharma Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-masked, two-treatment, single-period, parallel design, multiple dose at multiple clinical trial sites designed to demonstrate bioequivalence with clinical endpoint in subjects with chronic open-angle glaucoma or ocular hypertension in both eyes. Test Product - Bimatoprost Ophthalmic Solution, 0.01% of Mankind Pharma Limited, India Reference Product - LUMIGAN® (Bimatoprost Ophthalmic Solution) 0.01% of Allergan, Inc.,

Detailed description

Subjects with chronic open-angle glaucoma or ocular hypertension in both the eyes and meeting all the mentioned inclusion criteria and none of the exclusion criteria will be identified. Qualifying Intra Ocular Pressure (IOPs) following wash-out, at baseline (Day 0 at anytime of the day) should be ≥ 22 milli meter mercury (mm Hg) and ≤ 34 mm Hg in each eye and any asymmetry of IOP between the eyes no greater than 5 mm Hg. Subjects will receive one drop of investigational product (either A or B) in both the eyes every evening at approximately 10:00 pm ± 2 hours for 42 days. The study subjects will undergo clinical evaluations throughout the study in order to assess efficacy and safety. Study subject primary endpoint evaluation will be assessed after 2 weeks (day 14) and 6 weeks ( Day 42) of treatment for each study subject deemed eligible for evaluation. The primary bioequivalence comparison is between the test and reference products for the mean difference in intraocular pressure (IOP) of both eyes between the two treatment groups at six time points, i.e., at 00.00 hours (between 8:00am and 10:00 am), 04.00 hours (at 4 hours after 00.00 hours) and 08.00 hours ( at 8 hours after 00.00 hours) on Day 14 (week 2) and Day 42 (week 6) visits.

Conditions

• Glaucoma, Open-Angle

Interventions

Type	Name	Description
DRUG	Test - Bimatoprost 0.01% Ophthalmic Solution	Subjects in one arm will receive one drop of the test drug in both the eyes every evening at approximately 10:00 pm ± 2 hours for 42 days.
DRUG	Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution)	Subjects in the second arm will receive one drop of the reference drug in both the eyes every evening at approximately 10:00 pm ± 2 hours for 42 days.

Timeline

• Start date: 2021-10-02
• Primary completion: 2022-08-11
• Completion: 2022-08-11
• First posted: 2021-05-18
• Last updated: 2022-12-13

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study