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COMPLETEDPHASE3

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

Multi-Center, Randomized, Double-Masked, Active Controlled, Parallel Group Study to Compare Perrigo's Brinzolamide Ophthalmic Suspension 1% to Azopt® in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Both Eyes

NCT04024072•Padagis LLC

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

Locations (1)

James D. Branch Ophthalmology

Winston-Salem, North Carolina, United States

Key Dates

Start Date

June 24, 2019

Primary Completion Date

February 26, 2020

Completion Date

April 30, 2020

Last Updated

March 6, 2023

Enrollment

495

ACTUAL participants

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

Brinzolamide 1% ophthalmic suspension

DRUG

Azopt 1% Ophthalmic Suspension

DRUG

DSLT for Reducing Medication in Glaucoma

NCT07390890

Primary Open Angle GlaucomaOcular Hypertension

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RECRUITINGNA

Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population

NCT05902871

Primary Open Angle GlaucomaOcular Hypertension+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

DSLT for Reducing Medication in Glaucoma

Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population

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