Status: Recruiting

A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes

A randomized, double-blind, parallel-group, two-arm, multiple dose, multicenter, clinical endpoint bioequivalence study

Participants needed: 240

Trial details

Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Amneal Pharmaceuticals, LLCUpdated: Aug 6, 2024Locations: 4

Eligibility criteria

Subjects willing and able to provide voluntary informed consent and to follow pr... [+14]

Female who are pregnant, lactating or planning a pregnancy. [+27]

Status: Recruiting

Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® in the Treatment of Chronic Open-Angle Glaucoma or Ocular Hypertension in Both Eyes.

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.

Participants needed: 168

Trial details

Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Amneal Pharmaceuticals, LLCUpdated: Aug 10, 2022Locations: 9

Eligibility criteria

Subjects willing and able to provide voluntary informed consent and to follow pr... [+15]

Female who are pregnant, lactating or planning a pregnancy. [+27]

Clinical trials

A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes

Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® in the Treatment of Chronic Open-Angle Glaucoma or Ocular Hypertension in Both Eyes.