To Compare the Efficacy and Safety of Perrigo's Product to an FDA Approved Product for the Treatm… (NCT04944290) | Clinical Trial Compass
CompletedPhase 3
To Compare the Efficacy and Safety of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocular Hypertension in Both Eyes
United States447 participantsStarted 2021-05-28
Plain-language summary
To compare the efficacy and safety of Perrigo's product to an FDA approved product in the treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Both Eyes.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or nonpregnant females aged at least 18 years with chronic open angle glaucoma or ocular hypertension in both eyes
✓. Subject requires treatment of both eyes and is able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.
✓. Adequate wash-out period prior to baseline of any ocular hypotensive medication.
✓. Baseline (Day 0/hour 0) pressure ≥ 22 mm Hg and ≤ 34 mm Hg in each eye and any asymmetry of pressure between the eyes no greater than 5 mm Hg.
✓. Baseline best corrected visual acuity equivalent to 20/200 or better in each eye
Exclusion criteria
✕. Females who are pregnant, breast feeding, or planning a pregnancy.
✕. Females of childbearing potential who do not agree to utilize an adequate form of contraception
✕. Current, or past history of, severe hepatic or renal impairment
✕. Current, or history within two months prior to baseline of, significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye
✕. Current corneal abnormalities that would prevent accurate readings with the Goldmann applanation tonometer