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)

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)

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).

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open-Angle Glaucoma
• Intervention / Treatment: Drug: Alphagan; Drug: Istalol and Optive

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Petaluma, California, United States, 94954
      • North Bay Eye Associates, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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).
2. Stable use of Latanoprost 0.005% for a minimum of 30 days prior to screening visit.
3. VA of 20/200 or better in either eye
4. Pachymetry of 600 microns or less
5. Visual Field within 6 months of screening visit
6. Patients who use contact lenses are allowed to participate provided that they will remove lenses 15 minutes before dosing
7. Patients who satisfy all informed consent requirements may be included in the study.

Exclusion Criteria:

1. Females of childbearing potential (those who are not surgically sterile, postmenopausal or using a reliable birth control method) will be excluded from the study.
2. Any allergic component or contraindication to the study medications
3. Pachymetry of 600 microns or greater
4. Systemic corticosteroids not on a stable regimen within 30 days of screening visit.
5. Any concurrent topical agents that can not be discontinued during the course of the trial (natural tears are acceptable)
6. Significant ocular surface abnormalities
7. Patients with any form of glaucoma other than ocular hypertension or open-angle glaucoma
8. Patients who have been on an investigational therapy within 30 days prior to screening visit
9. History of ocular trauma within the past 3 months
10. Intraocular surgery within the past 3 months
11. Ocular laser surgery within the past 3 months
12. Any abnormality preventing reliable applanation tonometry of either eye
13. VA of 20/200 or greater in either eye
14. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 2; Alphagan	Drug: Alphagan; Alphagan: two drops a day for 28 days
ACTIVE_COMPARATOR: 1; Istalol and Optive	Drug: Istalol and Optive; Istalol: one drop a day for 28 days Optive: one drop a day for 28 days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bp Consulting, Inc
• Investigators: Principal Investigator: Jason Bacharach, M.D, North Bay Eye Associates,Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (ACTUAL): November 1, 2008
• Study Completion (ACTUAL): November 1, 2008

Study Registration Dates

• First Submitted: June 13, 2008
• First Submitted That Met QC Criteria: June 16, 2008
• First Posted (ESTIMATE): June 17, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): December 4, 2008
• Last Update Submitted That Met QC Criteria: December 2, 2008
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Brimonidine Tartrate
• Other Study ID Numbers: 5358