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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmneal Pharmaceuticals, LLC

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%

Treatment groups

240 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Amneal Pharmaceuticals, LLC

Lead sponsor

CBCC Global Inc.

Collaborator

Amneal EU, Limited

Collaborator