Actively Recruiting
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.
Led by Amneal Pharmaceuticals, LLC · Updated on 2022-08-10
168
Participants Needed
9
Research Sites
22 weeks
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
This is a randomized, double-blind, two-treatment, single-period, parallel design, multiple dose at multiple clinical trial sites designed to demonstrate bioequivalence with clinical endpoint in subjects with chronic open-angle glaucoma or ocular hypertension in both eyes. Test Product - Bimatoprost ophthalmic solution, 0.01% of Amneal EU, Limited Reference Product - LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of Allergan, Inc.
CONDITIONS
Official 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 informed consent and follow study rules
- Male or female aged 18 years or older
- Body mass index (BMI) of 18.5 kg/m2 or higher
- Diagnosed with chronic open-angle glaucoma or ocular hypertension in both eyes
- Need treatment in both eyes and able to stop or switch current eye pressure medications with a proper washout period
- Meet washout requirements for ocular hypotensive medications prior to baseline
- Baseline intraocular pressure (IOP) between 22 mm Hg and less than 35 mm Hg in each eye
- Likely to have IOP controlled with one medication as judged by the investigator
- Best corrected visual acuity of 20/100 or better in each eye using a standard chart
- Women of childbearing potential must use effective contraception methods during treatment
- No history of addiction to recreational drugs or alcohol
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy
- Known allergy or sensitivity to bimatoprost or ingredients
- Severe liver or kidney problems
- Significant eye diseases or infections within 2 months before baseline (except stable myopia, strabismus, or cataracts if approved)
- Corneal issues preventing accurate eye pressure measurement
- Significant vision loss in the investigator's opinion
- History of corneal grafts or pupil dilation contraindication
- Recent use of corticosteroid implants or eye/skin corticosteroids within specified time frames
- Recent eye surgeries within 6 to 12 months before baseline
- Only one sighted eye (amblyopia)
- History of uncontrolled eye pressure with bimatoprost alone
- Severe eye surface problems (redness, irritation)
- Severe retinal disease or advanced glaucoma damage
- Use of systemic medications affecting eye pressure without stable dosing for 3 months
- Corneal thickness outside 450 to 650 microns
- Uncontrolled systemic diseases such as cardiovascular or diabetes
- Recent recurrent seasonal eye allergies
- Other medical conditions or illnesses affecting study participation
- Participation in another clinical study within 90 days
- Positive test for Hepatitis B, Hepatitis C, HIV, pregnancy, or COVID-19 infection
AI-Screening
AI-Powered Screening
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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
CONTACT
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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