Actively Recruiting
Bioequivalence Study Comparing Bimatoprost 0.01% Ophthalmic Solution and LUMIGAN4 in Treating Chronic Open-Angle Glaucoma or Ocular Hypertension in Both Eyes
Led by Amneal Pharmaceuticals, LLC · Updated on 2022-08-10
168
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Amneal Pharmaceuticals, LLC
Lead Sponsor
C
CBCC Global Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the bioequivalence of two eye drop treatments, Bimatoprost 0.01% ophthalmic solution by Amneal EU and LUMIGAN4 (bimatoprost ophthalmic solution) 0.01% by Allergan, in adults with chronic open-angle glaucoma or ocular hypertension affecting both eyes. This randomized, double-blind, parallel-group study aims to compare these treatments by measuring their effects on intraocular pressure (IOP) as the primary clinical endpoint. Participants will be randomly assigned to receive either the test or reference bimatoprost eye drops, instilling one drop in both eyes every evening around 10:00 pm for 42 days. The study includes multiple doses over this period, with evaluations occurring at baseline, two weeks, and six weeks. The test and reference products are both ophthalmic solutions containing the same concentration of bimatoprost. Throughout the study, participants will have clinical assessments to monitor safety and efficacy, including IOP measurements at specific times (00:00, 04:00, and 08:00 hours) on days 14 and 42. Safety monitoring for adverse events will continue during the six-week treatment period. The main outcome is the mean difference in IOP between the treatment groups, helping to determine if the test product is equivalent to the reference product in controlling eye pressure.
CONDITIONS
Brief Title
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.
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
- Body mass index (BMI) of 18.50 kg/m2 or higher
- Diagnosed with chronic open-angle glaucoma or ocular hypertension in both eyes
- Require treatment of both eyes and able to discontinue or switch ocular hypotensive medications with appropriate washout
- Baseline intraocular pressure (IOP) between 22 mm Hg and less than 35 mm Hg in each eye
- IOP likely to be controlled with monotherapy as per investigator's discretion
- Best corrected visual acuity of 20/100 or better in each eye
- Women of childbearing potential must use effective contraception during dosing
- No history of addiction to recreational drugs or alcohol
You will not qualify if you...
- Pregnant, lactating, or planning pregnancy
- Known allergy or hypersensitivity to bimatoprost or related drugs
- Severe liver or kidney impairment
- Significant ocular diseases such as corneal edema, uveitis, ocular infection, or trauma within 2 months prior to baseline
- Corneal abnormalities preventing accurate intraocular pressure measurement
- Significant visual field loss
- History of corneal grafts
- Contraindication to pupil dilation
- Use of intraocular corticosteroid implants before baseline
- Use of contact lenses within 1 week before baseline
- Recent use of topical or systemic corticosteroids or high dose salicylate therapy
- Recent intraocular surgery or laser procedures within 6 to 12 months
- Amblyopia with only one sighted eye
- History of uncontrolled intraocular pressure on bimatoprost monotherapy
- Significant ocular surface irritation or hyperemia
- Severe retinal disease or glaucomatous damage with cup/disk ratio over 0.8
- Use of systemic medications affecting eye pressure without stable dosing for 3 months
- Central corneal thickness less than 450 microns or greater than 650 microns
- Uncontrolled systemic diseases such as cardiovascular disease, hypertension, or diabetes
- History of recurrent ocular allergies within 2 years
- Other medical conditions limiting study participation
- Participation in any clinical study within 90 days prior to dosing
- Positive tests for Hepatitis B, Hepatitis C, or HIV
- Positive pregnancy test
- Confirmed COVID-19 infection at screening or baseline visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 42 days
Participants will instill 1 drop of the assigned study drug in both eyes every evening for 42 days to treat chronic open-angle glaucoma or ocular hypertension.
Visits at baseline (Day 0), Day 14, and Day 42 for clinical evaluations
Trial Site Locations
Total: 9 locations
1
Eye Research Foundation Inc.
Newport Beach, California, United States, 92663
Actively Recruiting
2
North Bay Eye Associates, Inc.
Petaluma, California, United States, 94954
Actively Recruiting
3
Volusia Eye Associates
New Smyrna Beach, Florida, United States, 32169
Actively Recruiting
4
Clayton Eye Clinical Research, LLC
Morrow, Georgia, United States, 30260
Actively Recruiting
5
Coastal Research Associates, LLC
Roswell, Georgia, United States, 30076
Actively Recruiting
6
Toyos Clinic
Nashville, Tennessee, United States, 37215
Actively Recruiting
7
Keystone Research
Austin, Texas, United States, 78731
Not Yet Recruiting
8
Houston Eye Associates, North Loop
Houston, Texas, United States, 77008
Actively Recruiting
9
Cheyenne Eye Clinic & Surgery Center
Cheyenne, Wyoming, United States, 82001
Actively Recruiting
Research Team
I
Ilesh Changela, MBBS; MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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