NCT05401357 · Amneal Pharmaceuticals, LLC
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.
What this study is about
This is a randomly assigned, where neither patients nor doctors know which treatment is given, two-treatment, single-period, parallel design, multiple dose at multiple clinical trial sites designed to demonstrate bioequivalence with clinical goal measurement in subjects with chronic open-angle glaucoma or ocular hypertension in both eyes. Test Product - Bimatoprost ophthalmic solution, 0.
View original scientific description
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.
Interventions
DRUG
Test - Bimatoprost 0.01% Ophthalmic Solution
Subjects in one arm will receive one drop of the test drug in both the eyes every evening at approximately 10:00 pm ± 1 hour for 42 days.
DRUG
Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution)
Subjects in the other arm will receive one drop of the reference drug in both the eyes every evening at approximately 10:00 pm for 42 days.
Primary outcome measures
Mean difference in the intraocular pressure (IOP) of both eyes between the two treatment groups.
Time frame: Day 14 and 42 at 00.00 hours, 04.00 hours, and 08.00 hours.
Change in mean difference in the intraocular pressure (IOP) of both eyes between the two treatment groups at six time points, i.e., at 00.00 hour, 04.00 hours, and 08.00 hours at Day 14 (Week 2) and Day 42 (Week 6) visits
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subjects willing and able to provide voluntary informed consent and to follow protocol requirements.
- Male or females aged ≥18 years.
- Subjects having body mass index (BMI) ≥18.50 kg/m2.
- Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes.
- Subjects requiring treatment of both eyes and able to discontinue the use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.
- Adequate washout period prior to baseline of any ocular hypotensive medications as per the table below (to minimize potential risk to subjects due to intraocular pressure (IOP) elevations during the washout period, the Investigator may choose to substitute a parasympathomimetic or carbonic anhydrase inhibitor in place of a sympathomimetic, alpha-agonist, beta-adrenergic blocking agent, or prostaglandin; however, all the subjects must have discontinued their ocular hypotensive medications for the minimum
Where
- Newport Beach, California
- Petaluma, California
- New Smyrna Beach, Florida
- Morrow, Georgia
- Roswell, Georgia
- Nashville, Tennessee
- Austin, Texas
- Houston, Texas
- Cheyenne, Wyoming
Collaborators
CBCC Global Research
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 10, 2022 · Source of record for eligibility and locations