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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.

New Smyrna Beach, FL
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
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Pivotal Trial

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.

See full description
Eligible Conditions
  • Ocular Hypertension
  • Pigmentary Glaucoma
  • Open-Angle Glaucoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 14 and 42 at 00.00 hours, 04.00 hours, and 08.00 hours.
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 14 and 42 at 00.00 hours, 04.00 hours, and 08.00 hours. for reporting.

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

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.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Closest Location:Volusia Eye Associates· New Smyrna Beach, FL

Who is running the clinical trial?

Amneal Pharmaceuticals, LLCLead Sponsor
12 Previous Clinical Trials
28,337 Total Patients Enrolled
1 Trials studying Ocular Hypertension
240 Patients Enrolled for Ocular Hypertension
CBCC Global ResearchNETWORK
7 Previous Clinical Trials
1,115 Total Patients Enrolled
~46 spots leftby Mar 2026
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