This is a randomized, double-blind, 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 Amneal EU, Limited 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. At baseline (Day 0), subjects qualifying Intra Ocular Pressure (IOPs) following wash-out, with difference between the IOP in left and right eyes not being more than 5 mm Hg, will be randomized. Subjects will instill 1 drop of study drug (either T or R) in both eyes every evening at approximately 10:00 pm for 42 days. The study subjects will undergo clinical evaluations throughout the study in order to assess safety and efficacy. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
168
Subjects in one arm will receive one drop of the test drug in both the eyes every evening at approximately 10:00 pm ± 1 hour for 42 days.
Subjects in the other arm will receive one drop of the reference drug in both the eyes every evening at approximately 10:00 pm for 42 days.
Eye Research Foundation Inc.
Newport Beach, California, United States
RECRUITINGNorth Bay Eye Associates, Inc.
Petaluma, California, United States
RECRUITINGVolusia Eye Associates
New Smyrna Beach, Florida, United States
RECRUITINGClayton Eye Clinical Research, LLC
Morrow, Georgia, United States
RECRUITINGCoastal Research Associates, LLC
Roswell, Georgia, United States
RECRUITINGToyos Clinic
Nashville, Tennessee, United States
RECRUITINGKeystone Research
Austin, Texas, United States
NOT_YET_RECRUITINGHouston Eye Associates, North Loop
Houston, Texas, United States
RECRUITINGCheyenne Eye Clinic & Surgery Center
Cheyenne, Wyoming, United States
RECRUITINGMean difference in the intraocular pressure (IOP) of both eyes between the two treatment groups.
Change in mean difference in the intraocular pressure (IOP) of both eyes between the two treatment groups at six time points, i.e., at 00.00 hour, 04.00 hours, and 08.00 hours at Day 14 (Week 2) and Day 42 (Week 6) visits
Time frame: Day 14 and 42 at 00.00 hours, 04.00 hours, and 08.00 hours.
AE Monitoring for Safety of Bimatoprost ophthalmic solution 0.01%
Safety will be evaluated throughout the study based on adverse event monitoring,
Time frame: AE Monitoring for Safety will be evaluated throughout the study for 6 weeks.
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