Bioequivalence Study for Bimatoprost Ophthalmic Solution in Glaucoma and Ocular Hypertension
This study is comparing two eye drop solutions, Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® (Bimatoprost Ophthalmic Solution 0.01%), to see if they work similarly in treating chronic open-angle glaucoma or ocular hypertension (high pressure in the eye). You could be eligible if you are 18 or older, have chronic open-angle glaucoma or ocular hypertension in both eyes, and meet other health requirements. The study will measure the difference in eye pressure between the two groups after 14 and 42 days of treatment to determine if the solutions are equally effective. The current recruitment status is unclear.
- Study design
- This is a randomized, double-blind study with two treatment groups and plans to enroll 168 participants.
- What's involved
- You would instill one drop of the assigned study drug in both eyes every evening for 42 days. You will also have clinical evaluations throughout the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your eye pressure will be measured after 14 and 42 days of treatment.
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NCT05401357
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.
Recruiting
PHASE3Ages 18+InterventionalTreatmentAmneal Pharmaceuticals, LLC
~168 participants
Updated 2022-08-10 on ClinicalTrials.gov
What's tested:Test - Bimatoprost 0.01% Ophthalmic SolutionReference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution)
At a glance
Recruiting sites
8 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean difference in the intraocular pressure (IOP) of both eyes between the two treatment groups.
Measured over Day 14 and 42 at 00.00 hours, 04.00 hours, and 08.00 hours.
Conditions
Where it's being run
9 sites across 6 statesCalifornia2
Georgia2
Texas2
Florida1
Tennessee1
Wyoming1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 washout period.
Baseline (Day 0/hour 0) IOP ≥22 mm Hg and \<35 mm Hg in each eye,
Subjects' IOP is likely to be controlled with monotherapy as per the Investigator's discretion.
Baseline best corrected visual acuity equivalent to Snellen acuity of 20/100 or better in each eye, using a logarithmic visual acuity chart for testing at 10 feet (3 meters).
Women of childbearing potential (defined as women physiologically capable of becoming pregnant unless they are using an effective method of contraception during the dosing of the study drug) practicing any of the following acceptable methods of contraception:
No history of addiction to any recreational drug or drug dependence or alcohol addiction.
Current corneal abnormalities that would prevent accurate IOP readings with Goldmann applanation tonometer.
Functionally significant visual field loss in the Investigators' opinion.
Subject with corneal grafts.
Subject has contraindication to pupil dilation
Use at any time prior to baseline of an intraocular corticosteroid implant
Use of contact lens within 1 week prior to baseline
Use within 2 weeks prior to baseline of 1) a topical ophthalmic corticosteroid or 2) a topical corticosteroid
Use within 1 month prior to baseline of 1) a systemic corticosteroid or 2) high dose salicylate therapy defined as 325 mg/day and taken on 3 consecutive days.
Use within 6 months prior to baseline of intravitreal or subtenon injection of an ophthalmic corticosteroid
Underwent within 6 months prior to baseline any other intraocular surgery (e.g., cataract surgery).
Underwent within 12 months prior to baseline any refractive surgery, filtering surgery, or laser surgery for IOP reduction (e.g., laser trabeculoplasty).
Amblyopia - only one sighted eye.
Subjects with a history of IOP previously uncontrolled on bimatoprost monotherapy
Significant ocular surface findings (e.g., hyperemia or irritation, mild or greater) in either eye found on gross macroscopic or slit lamp examination
Severe retinal disease or other severe ocular pathology, such as glaucomatous damage with a cup/disk ratio greater than 0.8 (not including physiological cupping in the Investigators' opinion) or split fixation
Chronic use of any systemic medication that may affect IOP with less than 3 months stable dosing regimen (i.e., sympathomimetic agents, beta-adrenergic blocking agents, alpha-agonists, alpha-adrenergic blocking agents, calcium channel blockers, angiotensin-converting enzyme inhibitors, etc.)
Central Corneal thickness (CCT) \<450 microns or \>650 microns
Known history or presence of any uncontrolled systemic disease (e.g., cardiovascular disease, hypertension, diabetes mellitus, hepatic impairment, etc.)
History of recurrent ocular seasonal allergies within the past 2 years
Any other medical condition or serious intercurrent illness that, in the Investigator's opinion, may make it undesirable for the subject to participate in the study and would limit adherence to the study requirements
Participation in any clinical study within 90 days before the first dose of the study drug
Subjects with documented history of positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) infection
Subjects with positive urine pregnancy test
Subjects with confirmed novel coronavirus infection (COVID-19).
Exclusion
Female who are pregnant, lactating or planning a pregnancy.
Contraindication or known hypersensitivity to Bimatoprost, related class of drugs, or any of the excipients of formulation.
Current or past history of severe hepatic or renal impairment.
What this trial measures
- Mean difference in the intraocular pressure (IOP) of both eyes between the two treatment groups.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