A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes

Part of paid clinical trials in Bakersfield, California.

Sponsor
Amneal Pharmaceuticals, LLC
Study ID
NCT06267274
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bimatoprost Ophthalmic Solution, 0.01% — DRUG
    1 drop of ophthalmic solution instill in both eyes every night at 10:00 pm (±1 hours) for 42 days (6 weeks) (± 4 days) as per the randomization schedule.
  • LUMIGAN® (bimatoprost ophthalmic solution) 0.01% — DRUG
    1 drop of ophthalmic solution instill in both eyes every night at 10:00 pm (±1 hours) for 42 days (6 weeks) (± 4 days) as per the randomization schedule.

Study Details

A randomized, double-blind, parallel-group, two-arm, multiple dose, multicenter, clinical endpoint bioequivalence study

Key Dates

Start date
Apr 1, 2024
Status verified
Aug 2024
Primary completion
Mar 1, 2025
Completion
May 1, 2025

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bimatoprost Ophthalmic Solution, 0.01%
    Test Product: Bimatoprost Ophthalmic Solution, 0.01%
  • Active Comparator: LUMIGAN® (bimatoprost ophthalmic solution) 0.01%
    Reference Product: LUMIGAN® (bimatoprost ophthalmic solution) 0.01%

Primary Outcome Measure

Primary Endpoint [ Time Frame: 00.00 hour, 04.00 hours (4 hours ±1 hour after 00.00 hour), and 08.00 hours (8 hours ±1 hour after 00.00 hour) at Day 14 (Week 2) (± 4 days) and Day 42 (Week 6) (± 4 days) visits ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
West Coast Eye InstituteBakersfieldCalifornia93308
Sandeep Walia, MD
Eye Research FoundationNewport BeachCalifornia92663
David Wirta, MD
Clayton Eye ResearchMorrowGeorgia30260
Kim Jong, MD
Houston Eye AssociatesHoustonTexas77008
Kevin Jong, MD

Find similar trials in Bakersfield, CA

By condition
Glaucoma
By specialty
Ophthalmology
By research site
West Coast Eye Institute· Bakersfield, CAEye Research Foundation· Newport Beach, CAClayton Eye Research· Morrow, GAHouston Eye Associates· Houston, TX

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