Overview

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

Status:
Completed
Trial end date:
2020-04-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Perrigo Company
Treatments:
Brinzolamide
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