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Cosopt Versus Xalatan

Primary Purpose

Open-Angle Glaucoma, Ocular Hypertension

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

timolol maleate 0.5%

dorzolamide/timolol maleate fixed combination

latanoprost 0.005%

placebo

About this trial

This is an interventional treatment trial for Open-Angle Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: adults with primary open-angle, pigmentary, or exfoliation glaucoma, or ocular hypertenstion intraocular pressure should be 22 to 30 mm Hg inclusive on timolol BID at the 08:00 H ETDRS visual acuity must be 1.0 or better in both eyes Exclusion Criteria: any contraindications to study medications any anticipated change in systemic hypertensive therapy during the trial

Sites / Locations

Central Florida Eye Associates
Midwest Eye Center SC

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00273429

First Posted

January 6, 2006

Last Updated

January 8, 2007

Sponsor

Pharmaceutical Research Network

1. Study Identification

Unique Protocol Identification Number

NCT00273429

Brief Title

Cosopt Versus Xalatan

Study Type

Interventional

2. Study Status

Record Verification Date

January 2007

Overall Recruitment Status

Completed

Study Start Date

April 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Pharmaceutical Research Network

4. Oversight

5. Study Description

Brief Summary

To compare the 24-hour efficacy and safety, measured every three hours, of the dorzolamide/timolol fixed combination given twice daily versus latanoprost and placebo each given once daily.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Open-Angle Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

timolol maleate 0.5%

Intervention Type

Drug

Intervention Name(s)

dorzolamide/timolol maleate fixed combination

Intervention Type

Drug

Intervention Name(s)

latanoprost 0.005%

Intervention Type

Drug

Intervention Name(s)

placebo

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William C. Stewart, MD

Organizational Affiliation

Pharmaceutical Research Network, LLC

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Jay Mulaney, MD

Organizational Affiliation

Central Florida Eye Associates

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sriram Sonty, MD, FACS

Organizational Affiliation

Midwest Eye Center SC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Central Florida Eye Associates

City

Lakeland

State/Province

Florida

ZIP/Postal Code

33805

Country

United States

Facility Name

Midwest Eye Center SC

City

Bourbonnais

State/Province

Illinois

ZIP/Postal Code

60914

Country

United States

12. IPD Sharing Statement

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Cosopt Versus Xalatan

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