About this trial
A randomized, double-blind, parallel-group, two-arm, multiple dose, multicenter, clinical endpoint bioequivalence study
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Bimatoprost Ophthalmic Solution, 0.01%
- LUMIGAN® (bimatoprost ophthalmic solution) 0.01%