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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
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* Drug: Brinzolamide/brimonidine ophthalmic suspension
* Drug: Simbrinza 0.2%/1% Ophthalmic Suspension


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perrigo active<br> | Drug: Brinzolamide/brimonidine ophthalmic suspension<br>* Test product<br>|
| Active Comparator: Reference active<br> | Drug: Simbrinza 0.2%/1% Ophthalmic Suspension<br>* Reference product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |