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To Compare the Efficacy and Safety of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocular Hypertension in Both Eyes

Primary Purpose

Glaucoma, Open-Angle, Ocular Hypertension

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Brinzolamide/brimonidine ophthalmic suspension

Simbrinza 0.2%/1% Ophthalmic Suspension

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

James D. Branch Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Perrigo active

Reference active

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04944290

First Posted

June 11, 2021

Last Updated

March 9, 2023

Sponsor

Padagis LLC

1. Study Identification

Unique Protocol Identification Number

NCT04944290

Brief Title

To Compare the Efficacy and Safety of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocular Hypertension in Both Eyes

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

May 28, 2021 (Actual)

Primary Completion Date

March 11, 2022 (Actual)

Study Completion Date

June 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Padagis LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

To compare the efficacy and safety of Perrigo's product to an FDA approved product in the treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Both Eyes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Open-Angle, Ocular Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

447 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Perrigo active

Arm Type

Experimental

Arm Title

Reference active

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Brinzolamide/brimonidine ophthalmic suspension

Intervention Description

Test product

Intervention Type

Drug

Intervention Name(s)

Simbrinza 0.2%/1% Ophthalmic Suspension

Intervention Description

Reference product

Primary Outcome Measure Information:

Title

Mean change in intra-ocular pressure

Description

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Facility Information:

Facility Name

James D. Branch Ophthalmology

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27101

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

To Compare the Efficacy and Safety of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocular Hypertension in Both Eyes

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