Lumigan Versus Cosopt

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

bimatoprost 0.03%

dorzolamide 2%/timolol maleate 0.5% fixed combination

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 a diagnosis of bilateral open-angle glaucoma including: primary, pigment dispersion or exfoliation in both eyes on no therapy the intraocular pressure should be 22-29 mm Hg inclusive at the 8:00 AM measurement visual acuity should be 20/200 or better in each eye Exclusion Criteria: historical failure to respond to topical beta-blockers in a clinically meaningful manner any contraindication to study medications any anticipated change, or modification in the 6 weeks prior to Visit 1, in systemic hypertensive therapy during the trial

Sites / Locations

Taustine Eye Center
Glaucoma Consultants & Center for Eye Research, PA
Houston Eye Associates

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00273455

First Posted

January 6, 2006

Last Updated

November 18, 2008

Sponsor

Pharmaceutical Research Network

1. Study Identification

Unique Protocol Identification Number

NCT00273455

Brief Title

Lumigan Versus Cosopt

Study Type

Interventional

2. Study Status

Record Verification Date

November 2008

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pharmaceutical Research Network

4. Oversight

5. Study Description

Brief Summary

To compare the intraocular pressure effect and safety of the dorzolamide/timolol fixed combination given twice daily versus bimatoprost given once every evening in patients with open-angle glaucoma in patients insufficiently controlled on latanoprost monotherapy

6. Conditions and Keywords

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

Open-Angle Glaucoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

34 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

bimatoprost 0.03%

Intervention Type

Drug

Intervention Name(s)

dorzolamide 2%/timolol maleate 0.5% fixed combination

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 a diagnosis of bilateral open-angle glaucoma including: primary, pigment dispersion or exfoliation in both eyes on no therapy the intraocular pressure should be 22-29 mm Hg inclusive at the 8:00 AM measurement visual acuity should be 20/200 or better in each eye Exclusion Criteria: historical failure to respond to topical beta-blockers in a clinically meaningful manner any contraindication to study medications any anticipated change, or modification in the 6 weeks prior to Visit 1, in systemic hypertensive therapy during the trial

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

Robert D. Williams, MD

Organizational Affiliation

Taustine Eye Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Robert H. Stewart, MD

Organizational Affiliation

Houston Eye Associates

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Elizabeth D. Sharpe, MD

Organizational Affiliation

Glaucoma Consultants & Center for Eye Research, PA

Official's Role

Principal Investigator

Facility Information:

Facility Name

Taustine Eye Center

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40217

Country

United States

Facility Name

Glaucoma Consultants & Center for Eye Research, PA

City

Mt. Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

Facility Name

Houston Eye Associates

City

Houston

State/Province

Texas

ZIP/Postal Code

77025

Country

United States

Open-Angle Glaucoma

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