Cosopt Versus Xalacom

Back to results

Primary Purpose

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

dorzolamide 2%/timolol maleate 0.5% fixed combination

latanoprost 0.005%/timolol maleate 0.5% fixed combination

timolol maleate 0.5%

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 or pigment-dispersion glaucoma, or ocular hypertension at baseline the intraocular pressure should be 20 to 32 mm Hg inclusive at 08:00 measurement (Visit 2) after dosing with timolol the evening before the intraocular pressure should be 32 mm Hg or less at all the time points in both eyes at Visit 2 visual acuity should be 6/60 or better in the study eye(s) Exclusion Criteria: any anticipated change in systemic hypotensive therapy during the trial use of any corticosteroids by any route for more than two weeks during the study contraindications to study medicines

Sites / Locations

Lawson Health Research Insitute
University Eye Clinic

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00273481

First Posted

January 6, 2006

Last Updated

November 18, 2008

Sponsor

Pharmaceutical Research Network

1. Study Identification

Unique Protocol Identification Number

NCT00273481

Brief Title

Cosopt Versus Xalacom

Study Type

Interventional

2. Study Status

Record Verification Date

November 2008

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pharmaceutical Research Network

4. Oversight

5. Study Description

Brief Summary

To compare the intraocular pressure efficacy and safety of the DTFC given twice daily versus the LTFC given once every morning following a run-in period with timolol maleate given twice 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

Enrollment

33 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

dorzolamide 2%/timolol maleate 0.5% fixed combination

Intervention Type

Drug

Intervention Name(s)

latanoprost 0.005%/timolol maleate 0.5% fixed combination

Intervention Type

Drug

Intervention Name(s)

timolol maleate 0.5%

Intervention Type

Drug

Intervention Name(s)

placebo

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: adults with primary open-angle or pigment-dispersion glaucoma, or ocular hypertension at baseline the intraocular pressure should be 20 to 32 mm Hg inclusive at 08:00 measurement (Visit 2) after dosing with timolol the evening before the intraocular pressure should be 32 mm Hg or less at all the time points in both eyes at Visit 2 visual acuity should be 6/60 or better in the study eye(s) Exclusion Criteria: any anticipated change in systemic hypotensive therapy during the trial use of any corticosteroids by any route for more than two weeks during the study contraindications to study medicines

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

Cindy M. Hutnik, BSc, PhD, MD

Organizational Affiliation

Lawson Health Research Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Barbara Cvenkel, MD

Organizational Affiliation

University Eye Clinic Ljubljana

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lawson Health Research Insitute

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4G5

Country

Canada

Facility Name

University Eye Clinic

City

Ljubljana

ZIP/Postal Code

A525

Country

Slovenia

Open-Angle Glaucoma, Ocular Hypertension

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial