Actively Recruiting
Bioequivalence Study Comparing Generic Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN4 for 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
8 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
Researchers are evaluating the bioequivalence of two eye drop treatments for adults with chronic open-angle glaucoma or ocular hypertension in both eyes. This randomized, double-blind, parallel-group clinical trial aims to compare a generic bimatoprost ophthalmic solution 0.01% with the branded LUMIGAN4 (bimatoprost ophthalmic solution) 0.01%. The study focuses on measuring changes in intraocular pressure (IOP) at specific times after dosing and monitoring safety through adverse event reports. Participants will be randomly assigned to receive either the test product or the reference product, each administered as one drop in both eyes every night at 10:00 pm (plus or minus one hour) for 42 days (6 weeks). Before starting treatment, subjects will undergo a washout period of 4 days to 4 weeks depending on their prior medications. The treatment groups will have nearly equal numbers of participants based on baseline IOP and corneal thickness measurements. During the study, participants will have their IOP measured at 00:00, 04:00, and 08:00 hours on Day 14 and Day 42 visits. Researchers will monitor safety by recording and analyzing any adverse events throughout the 6-week treatment period. The total participation includes screening, washout, treatment administration, and safety monitoring to assess the similarity and tolerability of the two bimatoprost eye drops.
CONDITIONS
Brief 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 voluntary informed consent and follow protocol requirements
- 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 ocular hypotensive medications for a washout period
- Completed adequate washout of ocular hypotensive medications before baseline
- Baseline intraocular pressure (IOP) between 22 mm Hg and less than 28 mm Hg in each eye, with less than 5 mm Hg difference between eyes
- IOP likely controlled with monotherapy as per Investigator's judgment
- Best corrected visual acuity of 20/100 or better in each eye
- Women of childbearing potential using effective contraception as specified
- No history of drug or alcohol addiction
You will not qualify if you...
- Pregnant, lactating, or planning pregnancy
- Recently diagnosed and treatment-naive for open-angle glaucoma or ocular hypertension
- Known allergy to bimatoprost or related medications
- Severe liver or kidney impairment
- Significant ocular diseases such as corneal edema, uveitis, infection, or trauma within 2 months prior to baseline
- Corneal abnormalities preventing accurate eye pressure measurement
- Significant visual field loss
- History of corneal grafts or contraindication to pupil dilation
- Use of intraocular corticosteroid implants or certain corticosteroids within specified timeframes before baseline
- Use of contact lenses within 1 week prior to baseline
- Recent eye surgeries within 6 to 12 months before baseline
- Amblyopia with only one sighted eye
- History of uncontrolled IOP on bimatoprost monotherapy
- Significant ocular surface irritation
- Severe retinal disease or glaucomatous damage with cup/disk ratio over 0.8
- Unstable use of systemic medications affecting IOP
- Central corneal thickness outside 450-650 microns
- Uncontrolled systemic diseases
- Recurrent ocular allergies in past 2 years
- Other medical conditions or illnesses limiting study participation
- Participation in another clinical study within 30 days prior to first dose
- Positive tests for Hepatitis B, C, or HIV
- Positive pregnancy test
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 6 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 4 days to 4 weeks (28 days)
Participants undergo a washout period to stop ocular hypotensive medications before starting the study treatment.
No visits during washout; assessments occur at baseline
Duration - 42 days (6 weeks) (± 4 days)
Participants instill 1 drop of study drug in both eyes every night for 42 days (6 weeks).
Visits at Day 14 (Week 2) and Day 42 (Week 6) including multiple intraocular pressure measurements at 00:00, 04:00, and 08:00 hours
Duration - 6 weeks
Participants are monitored for safety and adverse events throughout the 6-week treatment period.
Ongoing monitoring during treatment visits
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
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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