RecruitingOpen-angle GlaucomaOcular Hypertension
A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes
Eligible age
18+ yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
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About this study
A randomized, double-blind, parallel-group, two-arm, multiple dose, multicenter, clinical endpoint bioequivalence study
Sponsor: Amneal Pharmaceuticals, LLC
You may qualify if…
- ✓ 1. Subjects willing and able to provide voluntary informed consent and to follow protocol requirements.
- ✓ 2. Male or females aged ≥18 years.
- ✓ 3. Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes
- ✓ 4. 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.
- ✓ 5. Adequate washout period prior to baseline of any ocular hypotensive medications as (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 .
- ✓ 6. Baseline (Day 0/hour 0) IOP ≥22 mm Hg and \<28 mm Hg in each eye, with difference between the IOP in left and right eyes not being more than 5 mm Hg
- ✓ 7. Subjects' IOP is likely to be controlled with monotherapy as per the Investigator's discretion.
- ✓ 8. 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).
You may not qualify if…
- ✕ 1. Female who are pregnant, lactating or planning a pregnancy.
- ✕ 2. Subjects recently diagnosed with open-angle glaucoma or ocular hypertension and who are treatment naive.
- ✕ 3. Contraindication or known hypersensitivity to Bimatoprost, related class of drugs, or any of the excipients of formulation.
- ✕ 4. Current or history of severe hepatic or renal impairment.
- ✕ 5. 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).
- ✕ 6. Current corneal abnormalities that would prevent accurate IOP readings with Goldmann applanation tonometer.
- ✕ 7. Functionally significant visual field loss in the Investigators' opinion.
- ✕ 8. Subject with corneal grafts.
Where it's recruiting
Source: ClinicalTrials.gov · NCT06267274 · last updated 2024-08-06