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.,
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
310
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.
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.
CBCC Global Research Site:011
Bakersfield, California, United States
CBCC Global Research Site 016
Mission Hills, California, United States
CBCC Global Research Site 017
Newport Beach, California, United States
Mean Difference in Intraocular Pressure (IOP) of Both Eyes Between the Two Treatment Groups at Six Time Points
Change in mean difference in intraocular pressure (IOP) of both the eyes between the two treatment groups at six time points, i.e., at 00.00 hours (between 8:00 am 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.
Time frame: Day 14 and 42 at 00.00 hours (between 8:00 AM 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)
Safety and efficacy of Bimatoprost 0.01% Ophthalmic Solution
To monitor the adverse events and safety of the subjects and tolerability of Bimatoprost 0.01% Ophthalmic Solution
Time frame: Safety will be evaluated throughout the study (6 weeks) and telephonic safety follow-up on day 49±3 days
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