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

Phase 3

Completed

• Conditions: Glaucoma, Open-Angle; Ocular Hypertension
• Interventions: Drug: Azopt 1% Ophthalmic Suspension; Drug: Brinzolamide 1% ophthalmic suspension

• Registration Number: NCT04024072
• Lead Sponsor: Padagis LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-24
• Study First Submitted: 2019-07-16
• Study First Submitted QC: 2019-07-16
• Study First Posted: 2019-07-18
• Primary Completion: 2020-02-26
• Study Completion: 2020-04-30
• Status Verified: 2023-02
• Results First Submitted: 2023-02-03
• Results First Submitted QC: 2023-02-03
• Last Update Submitted: 2023-02-03
• Results First Posted: 2023-03-06
• Last Update Posted: 2023-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 495

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reference active	Azopt 1% Ophthalmic Suspension	Azopt ophthalmic suspension
Perrigo active	Brinzolamide 1% ophthalmic suspension	Test product

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

James D. Branch Ophthalmology; 🇺🇸 Winston-Salem, North Carolina, United States