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Prostaglandin Analog
Test - Bimatoprost 0.01% Ophthalmic Solution for Open-Angle Glaucoma (Glaucoma Trial)
Phase 3
Waitlist Available
Research Sponsored by Mankind Pharma Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or non-pregnant females aged ≥18 years having body mass index (BMI) ≥ 17 calculated as weight in kg/height in m2.
Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 14 and 42 at 00.00 hours (between 8:00 am and 10:00 am), 04.00 hours (at 4 hours after 00.00 hours), and 08.00 hours (at 8 hours after 00.00 hours)
Awards & highlights
Glaucoma Trial Summary
This study is evaluating whether a drug called bimatoprost is bioequivalent to a drug called Lumigan.
Eligible Conditions
- Open-Angle Glaucoma
Glaucoma Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowGlaucoma Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 14 and 42 at 00.00 hours (between 8:00 am and 10:00 am), 04.00 hours (at 4 hours after 00.00 hours), and 08.00 hours (at 8 hours after 00.00 hours)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 14 and 42 at 00.00 hours (between 8:00 am and 10:00 am), 04.00 hours (at 4 hours after 00.00 hours), and 08.00 hours (at 8 hours after 00.00 hours)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean Difference in Intraocular Pressure (IOP) of Both Eyes Between the Two Treatment Groups at Six Time Points
Secondary outcome measures
Safety and efficacy of Bimatoprost 0.01% Ophthalmic Solution
Glaucoma Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Bimatoprost 0.01% Ophthalmic SolutionExperimental Treatment1 Intervention
Bimatoprost Pharmaceutical dosage form: Ophthalmic Solution Strength: 0.01% Manufactured by: Mankind Pharma Limited, India.
Intervention Drug: Test - Bimatoprost 0.01% Ophthalmic Solution
Group II: LUMIGAN® 0.01% Ophthalmic SolutionActive Control1 Intervention
LUMIGAN® ( Contains Bimatoprost) Pharmaceutical dosage form: Ophthalmic Solution Strength: 0.01% Manufactured by: Allergan, Inc.,
Intervention Drug: Reference - Bimatoprost 0.01% Ophthalmic Solution
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Test - Bimatoprost 0.01% Ophthalmic Solution
2021
Completed Phase 3
~310
Find a Location
Who is running the clinical trial?
CBCC Global ResearchNETWORK
7 Previous Clinical Trials
973 Total Patients Enrolled
Mankind Pharma LimitedLead Sponsor
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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