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
Condition: Glaucoma, Open-Angle; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle; Hypertension
Intervention: Brinzolamide 1% ophthalmic suspension; Azopt 1% Ophthalmic Suspension
Intervention description: Test product; Reference product
Intervention MeSH terms: Brinzolamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 495.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or nonpregnant females aged at least 18 years with chronic open angle glaucoma or
             ocular hypertension in both eyes

          2. 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.

          3. Adequate wash-out period prior to baseline of any ocular hypotensive medication.

          4. 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.

          5. Baseline best corrected visual acuity equivalent to 20/200 or better in each eye

        Exclusion Criteria:

          1. Females who are pregnant, breast feeding, or planning a pregnancy.

          2. Females of childbearing potential who do not agree to utilize an adequate form of
             contraception

          3. Current, or past history of, severe hepatic or renal impairment

          4. 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

          5. Current corneal abnormalities that would prevent accurate readings with the Goldmann
             applanation tonometer

          6. Functionally significant visual field loss

          7. Contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to
             any component of brinzolamide or sulfonamide therapy

          8. Use at any time prior to baseline of an intraocular corticosteroid implant

          9. Use within one week prior to baseline of contact lens

         10. Use within two weeks prior to baseline of: 1) topical ophthalmic corticosteroid, or 2)
             topical corticosteroid

         11. Use within one month prior to baseline of: 1) systemic corticosteroid or 2) high-dose
             salicylate therapy

         12. Use within six months prior to baseline of intravitreal or subtenon injection of
             ophthalmic corticosteroid

         13. Having undergone within six months prior to baseline any other intraocular surgery
             (e.g., cataract surgery)

         14. Having undergone within twelve months prior to baseline refractive surgery, filtering
             surgery, or laser surgery for pressure reduction