Comparison of Istalol™ 0.5% QD (Timolol Maleate/Sorbitol Complex, ISTA Pharmaceutical) to Brimonidine Tartrate 0.1% BID as Adjunctive Therapy to Latanoprost 0.005% in Adults With Ocular Hypertension (OHT) or Open-Angle Glaucoma (OAG)

Study Overview
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Brief Summary
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To assess the additional benefit of common adjunctive classes on the diurnal IOP curve in patients assessed as needing additional treatment to reach target intraocular pressure (IOP). To demonstrate superiority of IOP control with Istalol 0.5% QD compared to Brimonidine Tartrate 0.2% BID as adjunctive therapy in adults with uncontrolled IOP's (determined by P.I. based on target pressures) currently treated with Latanoprost 0.05% in the study eye(s).

Official Title
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Randomized, Investigator Masked Comparison of Istalol™ 0.5% QD (Timolol Maleate/Sorbitol Complex, ISTA Pharmaceutical) to Brimonidine Tartrate 0.1% BID as Adjunctive Therapy to Latanoprost 0.005% in Adults With Ocular Hypertension (OHT) or Open-Angle Glaucoma (OAG)

Conditions
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Ocular Hypertension, Open-Angle Glaucoma

Intervention / Treatment
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* Drug: Istalol and Optive
* Drug: Alphagan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients, male or female of any race or ethnicity, 18 years of age or older, diagnosed with ocular hypertension or open-angle glaucoma (with or without pseudoexfoliative or pigmentary dispersion component). Stable use of Latanoprost 0.005% for a minimum of 30 days prior to screening visit. VA of 20/200 or better in either eye Pachymetry of 600 microns or less Visual Field within 6 months of screening visit Patients who use contact lenses are allowed to participate provided that they will remove lenses 15 minutes before dosing Patients who satisfy all informed consent requirements may be included in the study. Exclusion Criteria: Females of childbearing potential (those who are not surgically sterile, postmenopausal or using a reliable birth control method) will be excluded from the study. Any allergic component or contraindication to the study medications Pachymetry of 600 microns or greater Systemic corticosteroids not on a stable regimen within 30 days of screening visit. Any concurrent topical agents that can not be discontinued during the course of the trial (natural tears are acceptable) Significant ocular surface abnormalities Patients with any form of glaucoma other than ocular hypertension or open-angle glaucoma Patients who have been on an investigational therapy within 30 days prior to screening visit History of ocular trauma within the past 3 months Intraocular surgery within the past 3 months Ocular laser surgery within the past 3 months Any abnormality preventing reliable applanation tonometry of either eye VA of 20/200 or greater in either eye History or evidence of clinically significant illness or conditions which would make the patient, in the opinion of the investigator, not suitable for the study

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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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>Alphagan | Drug: Alphagan<br>* Alphagan: two drops a day for 28 days<br>|
| Active Comparator: 1<br>Istalol and Optive | Drug: Istalol and Optive<br>* Istalol: one drop a day for 28 days Optive: one drop a day for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough and peak intraocular pressure |  | 2-4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of study medication |  | 2-4 months |