To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocular Hypertension in Both Eyes

Completed · Phase 3

Conditions studied: Glaucoma, Open-Angle, Ocular Hypertension

In brief

To compare the safety and efficacy of Perrigo's product to an FDA approved product in the treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Both Eyes.

Key facts

Study ID

NCT04024072

Run by

Padagis LLC

People needed

495

Starts

2019-06-24

Expected to finish

2020-04-30

Last updated by the study team

2023-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Functionally significant visual field loss
• Contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to any component of brinzolamide or sulfonamide therapy
• Use at any time prior to baseline of an intraocular corticosteroid implant
• Use within one week prior to baseline of contact lens
• Use within two weeks prior to baseline of: 1) topical ophthalmic corticosteroid, or 2) topical corticosteroid
• Use within one month prior to baseline of: 1) systemic corticosteroid or 2) high-dose salicylate therapy
• Use within six months prior to baseline of intravitreal or subtenon injection of ophthalmic corticosteroid
• Having undergone within six months prior to baseline any other intraocular surgery (e.g., cataract surgery)
• Having undergone within twelve months prior to baseline refractive surgery, filtering surgery, or laser surgery for pressure reduction

Where it is running

• James D. Branch Ophthalmology — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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