Actively Recruiting
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
Led by Amneal Pharmaceuticals, LLC · Updated on 2024-08-06
240
Participants Needed
4
Research Sites
56 weeks
Total Duration
On this page
Sponsors
A
Amneal Pharmaceuticals, LLC
Lead Sponsor
C
CBCC Global Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
A randomized, double-blind, parallel-group, two-arm, multiple dose, multicenter, clinical endpoint bioequivalence study
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide informed consent and follow study rules
- Male or female aged 18 years or older
- Diagnosed with chronic open-angle glaucoma or ocular hypertension in both eyes
- Require treatment in both eyes and able to stop or switch current eye pressure medications with a washout period
- Completed adequate washout of ocular hypotensive medications before baseline
- Baseline intraocular pressure (IOP) between 22 and less than 28 mm Hg in each eye, with less than 5 mm Hg difference between eyes
- Investigator believes IOP can be controlled by monotherapy
- Visual acuity of 20/100 or better in each eye
- Women able to become pregnant must use effective contraception during the study
- No history of addiction to recreational drugs or alcohol
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy
- Recently diagnosed and treatment-naive for open-angle glaucoma or ocular hypertension
- Known allergy or reaction to bimatoprost or related medications
- Severe liver or kidney problems
- Recent or current significant eye diseases besides glaucoma or ocular hypertension
- Corneal problems preventing accurate eye pressure measurement
- Significant vision loss or only one sighted eye
- History of uncontrolled eye pressure on bimatoprost
- Significant eye surface irritation or severe retinal disease
- Use of certain systemic or eye medications affecting eye pressure within specified timeframes before baseline
- Recent eye surgeries including cataract, refractive, filtering, or laser surgeries
- Abnormal central corneal thickness outside 450 to 650 microns
- Uncontrolled systemic diseases like cardiovascular disease, hypertension, or diabetes
- History of recurrent seasonal eye allergies in past 2 years
- Other medical conditions that may affect study participation
- Participation in another clinical trial within 30 days before starting
- Positive tests for Hepatitis B, Hepatitis C, or HIV
- Positive pregnancy test at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
West Coast Eye Institute
Bakersfield, California, United States, 93308
Actively Recruiting
2
Eye Research Foundation
Newport Beach, California, United States, 92663
Actively Recruiting
3
Clayton Eye Research
Morrow, Georgia, United States, 30260
Actively Recruiting
4
Houston Eye Associates
Houston, Texas, United States, 77008
Actively Recruiting
Research Team
I
Ilesh Changela, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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