A randomized, double-blind, parallel-group, two-arm, multiple dose, multicenter, clinical endpoint bioequivalence study
Subjects willing and able to provide voluntary informed consent and to follow protocol requirements.
Male or females aged ≥18 years.
Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes
Subjects requiring treatment of both eyes and able to discontinue the use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.
Female who are pregnant, lactating or planning a pregnancy.
Subjects recently diagnosed with open-angle glaucoma or ocular hypertension and who are treatment naive.
Contraindication or known hypersensitivity to Bimatoprost, related class of drugs, or any of the excipients of formulation.
Current or history of severe hepatic or renal impairment.
Parallel
Bimatoprost Ophthalmic Solution, 0.01%
Drug1 drop of ophthalmic solution instill in both eyes every night at 10:00 pm (±1 hours) for 42 days (6 weeks) (± 4 days) as per the randomization schedule.
LUMIGAN® (bimatoprost ophthalmic solution) 0.01%
Drug1 drop of ophthalmic solution instill in both eyes every night at 10:00 pm (±1 hours) for 42 days (6 weeks) (± 4 days) as per the randomization schedule.
Primary Endpoint
Mean difference in the IOP of both eyes between the two treatment groups at 3 time points
Secondary Endpoint
The incidence of all adverse events reported during the study will be summarized by treatment group. Test and reference products will be compared for safety by analyzing nature, severity and frequency of treatment emergent adverse events.
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