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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)

NCT ID: NCT00698945

Last Updated: 2008-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-11-30

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).

Detailed Description

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Conditions

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Ocular Hypertension Open-Angle Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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2

Alphagan

Group Type ACTIVE_COMPARATOR

Alphagan

Intervention Type DRUG

Alphagan: two drops a day for 28 days

1

Istalol and Optive

Group Type ACTIVE_COMPARATOR

Istalol and Optive

Intervention Type DRUG

Istalol: one drop a day for 28 days Optive: one drop a day for 28 days

Interventions

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Istalol and Optive

Istalol: one drop a day for 28 days Optive: one drop a day for 28 days

Intervention Type DRUG

Alphagan

Alphagan: two drops a day for 28 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bp Consulting, Inc

NETWORK

Sponsor Role lead

Responsible Party

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North Bay Eye Associates, Inc.

Principal Investigators

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Jason Bacharach, M.D

Role: PRINCIPAL_INVESTIGATOR

North Bay Eye Associates,Inc.

Locations

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North Bay Eye Associates, Inc.

Petaluma, California, United States

Site Status

Countries

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United States

Other Identifiers

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5358

Identifier Type: -

Identifier Source: org_study_id