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Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% to LUMIGAN® In The Treatment of Chronic Open-Angle Glaucoma

NCT04890106 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2022-12-13

No results posted yet for this study

Summary

This is a randomized, double-masked, 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 Mankind Pharma Limited, India

Reference Product - LUMIGAN® (Bimatoprost Ophthalmic Solution) 0.01% of Allergan, Inc.,

Conditions

  • Glaucoma, Open-Angle

Interventions

DRUG

Test - Bimatoprost 0.01% Ophthalmic Solution

Subjects in one arm will receive one drop of the test drug in both the eyes every evening at approximately 10:00 pm ± 2 hours for 42 days.

DRUG

Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution)

Subjects in the second arm will receive one drop of the reference drug in both the eyes every evening at approximately 10:00 pm ± 2 hours for 42 days.

Sponsors & Collaborators

  • CBCC Global Research

    collaborator NETWORK

  • Mankind Pharma Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-02
Primary Completion
2022-08-11
Completion
2022-08-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04890106 on ClinicalTrials.gov