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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04944290
• Other study ID #: PRG-NY-20-002
• Status: Completed
• Phase: Phase 3
• Start date: May 28, 2021
• Est. completion date: June 21, 2022

Study information

• Verified date: March 2023
• Source: Padagis LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 447
• Est. completion date: June 21, 2022
• Est. primary completion date: March 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• Brinzolamide/brimonidine ophthalmic suspension
Test product
• Simbrinza 0.2%/1% Ophthalmic Suspension
Reference product

Locations

Country	Name	City	State
United States	James D. Branch Ophthalmology	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Padagis LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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