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

NCT ID: NCT04024072

Last Updated: 2023-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 495 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-24
• Study Completion Date: 2020-04-30

Brief 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.

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Perrigo active

Test product

Group Type: EXPERIMENTAL

Brinzolamide 1% ophthalmic suspension

Intervention Type: DRUG

Test product

Reference active

Azopt ophthalmic suspension

Group Type: ACTIVE_COMPARATOR

Azopt 1% Ophthalmic Suspension

Intervention Type: DRUG

Reference product

Interventions

Brinzolamide 1% ophthalmic suspension

Test product

Intervention Type: DRUG

Azopt 1% Ophthalmic Suspension

Reference product

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Padagis LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

James D. Branch Ophthalmology

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PRG-NY-19-001

Identifier Type: -

Identifier Source: org_study_id