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Assessing Cosopt Switch Patients

NCT ID: NCT00273442

Last Updated: 2008-11-19

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-04-30

Brief Summary

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To assess the safety and efficacy of a cohort of patients switched to the dorzolamide/timolol maleate fixed combination because they are insufficiently controlled on latanoprost monotherapy.

Detailed Description

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Conditions

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Ocular Hypertension Open-Angle Glaucoma Exfoliation Syndrome Glaucoma, Pigmentary

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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timolol maleate

Intervention Type DRUG

dorzolamide/timolol maleate fixed combination

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adults with clinical diagnosis of POAG, pigment-dispersion or exfoliation glaucoma or ocular hypertension
* the IOP on latanoprost must be 31 mm Hg or less in both eyes, and 21 to 31 mm Hg inclusive in at least one eye at 08:00 AM
* visual acuity should be 20/200 or better in each eye

Exclusion Criteria

* contraindications to study drugs
* anticipated change in systemic hypotensive therapy during the trial
* use of any corticosteroids by any route in the three months immediately prior to Visit 2
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pharmaceutical Research Network

OTHER

Sponsor Role lead

Principal Investigators

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William C. Stewart, MD

Role: STUDY_DIRECTOR

Pharmaceutical Research Network, LLC

Mark J. Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

Douglas G. Day, MD

Role: PRINCIPAL_INVESTIGATOR

Omni Eye Services

Sriram Sonty, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Midwest Eye Center

J. Charles Henry, MD

Role: PRINCIPAL_INVESTIGATOR

Little Rock Eye Clinic

Elizabeth D. Sharpe, MD

Role: PRINCIPAL_INVESTIGATOR

Glaucoma Consultants & Center for Eye Research

Locations

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Little Rock Eye Clinic

Little Rock, Arkansas, United States

Site Status

Omni Eye Services

Atlanta, Georgia, United States

Site Status

Midwest Eye Center

Bourbonnais, Illinois, United States

Site Status

Mark J. Weiss, MD

Tulsa, Oklahoma, United States

Site Status

Glaucoma Consultants & Center for Eye Research

Mt. Pleasant, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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PRN 05-007

Identifier Type: -

Identifier Source: org_study_id