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

NCT04024072 | Completed Phase 3 Results FDA Drug

• 1 other identifier: PRG-NY-19-001
• Study Type: interventional
• Target: 495
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Mean Change in Intra-ocular Pressure

  mean change in intra-ocular pressure of both eyes at four time points : at approximately 8:00 a.m. (hour 0; before the morning drop) and approximately 10:00 a.m. (hour 2) on Day 14 (Week 2) and Day 42 (Week 6) visits.

  6 weeks

Study Arms (2)

Perrigo active

EXPERIMENTAL

Test product

Drug: Brinzolamide 1% ophthalmic suspension

Reference active

ACTIVE COMPARATOR

Azopt ophthalmic suspension

Drug: Azopt 1% Ophthalmic Suspension

Interventions

Brinzolamide 1% ophthalmic suspension DRUG

Test product

Perrigo active

Azopt 1% Ophthalmic Suspension DRUG

Reference product

Reference active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Padagis LLC: lead

Study Sites (1)

James D. Branch Ophthalmology

Winston-Salem, North Carolina, 27101, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

brinzolamide

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Results Point of Contact

• Title: Jonathan Schwartz
• Organization: Padagis LLC

jonathan.schwartz@padagis.com

929-502-7291

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 18, 2019
• Study Start: June 24, 2019
• Primary Completion: February 26, 2020
• Study Completion: April 30, 2020
• Last Updated: March 6, 2023
• Results First Posted: March 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)