RecruitingGlaucoma, Open-AngleOcular Hypertension
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.
Eligible age
18+ yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
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About this study
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.
Sponsor: Amneal Pharmaceuticals, LLC
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
- ✕ Current or history within 2 months prior to baseline of any other significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye (Note: stable myopia, strabismus, and cataracts as per the Investigator's discretion will be allowed provided that the other inclusion/exclusion criteria are met).
- ✕ 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
Where it's recruiting
Source: ClinicalTrials.gov · NCT05401357 · last updated 2022-08-10