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

• Sponsor: Padagis LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04944290
• Collaborator: (none)
• Enrollment: 447
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.8
• Patients Per Site Per Month: 35

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Open-Angle; Ocular Hypertension	Drug: Brinzolamide/brimonidine ophthalmic suspension; Drug: Simbrinza 0.2%/1% Ophthalmic Suspension	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 447 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 28, 2021
• Actual Primary Completion Date: Mar 11, 2022
• Actual Study Completion Date: Jun 21, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Perrigo active	Drug: Brinzolamide/brimonidine ophthalmic suspension; Test product
Active Comparator: Reference active	Drug: Simbrinza 0.2%/1% Ophthalmic Suspension; Reference product

Outcome Measures

Primary Outcome Measures

1. Mean change in intra-ocular pressure [6 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	James D. Branch Ophthalmology	Winston-Salem	North Carolina	United States	27101

Sponsors and Collaborators

• Padagis LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Padagis LLC
• ClinicalTrials.gov Identifier: NCT04944290
• Other Study ID Numbers: PRG-NY-20-002
• First Posted: Jun 29, 2021
• Last Update Posted: Aug 22, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle; Hypertension; Brimonidine Tartrate; Brinzolamide

Study Results

No Results Posted as of Aug 22, 2022