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Prostaglandin Analog
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.
Phase 3
Recruiting
Research Sponsored by Amneal Pharmaceuticals, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 14 and 42 at 00.00 hours, 04.00 hours, and 08.00 hours.
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Summary
This trial is designed to show that a generic bimatoprost solution is equivalent to the brand name product in subjects with glaucoma or ocular hypertension.
Eligible Conditions
- Primary Open Angle Glaucoma
- Ocular Hypertension
- Open-Angle Glaucoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 14 and 42 at 00.00 hours, 04.00 hours, and 08.00 hours.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 14 and 42 at 00.00 hours, 04.00 hours, and 08.00 hours.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean difference in the intraocular pressure (IOP) of both eyes between the two treatment groups.
Secondary study objectives
AE Monitoring for Safety of Bimatoprost ophthalmic solution 0.01%
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Bimatoprost 0.01% Ophthalmic SolutionExperimental Treatment1 Intervention
Pharmaceutical dosage form contains LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of Allergan, Inc.
Group II: LUMIGAN® 0.01% Ophthalmic SolutionActive Control1 Intervention
Pharmaceutical dosage form contains LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of Allergan, Inc.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bimatoprost
FDA approved
Find a Location
Who is running the clinical trial?
Amneal Pharmaceuticals, LLCLead Sponsor
12 Previous Clinical Trials
28,337 Total Patients Enrolled
CBCC Global ResearchNETWORK
7 Previous Clinical Trials
1,115 Total Patients Enrolled