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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.

ConditionsGlaucoma, Open-AngleOcular Hypertension
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmneal Pharmaceuticals, LLC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects willing and able to provide voluntary informed consent and to follow protocol requirements.

Male or females aged ≥18 years.

Subjects having body mass index (BMI) ≥18.50 kg/m2.

Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes.

Disqualifiers

Female who are pregnant, lactating or planning a pregnancy.

Contraindication or known hypersensitivity to Bimatoprost, related class of drugs, or any of the excipients of formulation.

Current or past history of severe hepatic or renal impairment.

Current or history within 2 months prior to baseline of any other significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye (Note: stable myopia, strabismus, and cataracts as per the Investigator's discretion will be allowed provided that the other inclusion/exclusion criteria are met).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Test - Bimatoprost 0.01% Ophthalmic Solution

    Drug

    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.

  • Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution)

    Drug

    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.

Treatment groups

168 Participants
are divided into 2 treatment groups
Group A: Bimatoprost 0.01% Ophthalmic SolutionExperimental treatment 1 intervention
Group B: LUMIGAN® 0.01% Ophthalmic SolutionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean 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.

Secondary outcomes

1

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amneal Pharmaceuticals, LLC

Lead sponsor

CBCC Global Research

Collaborator

Source ClinicalTrials.gov
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