Lumigan Versus Cosopt - Tabular View

Tracking Information

First Received Date ^ICMJE

January 6, 2006

Last Updated Date

November 18, 2008

Start Date ^ICMJE

January 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00273455 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Lumigan Versus Cosopt

Official Title ^ICMJE

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment

Condition ^ICMJE

Open-Angle Glaucoma

Intervention ^ICMJE

Drug: bimatoprost 0.03%
Drug: dorzolamide 2%/timolol maleate 0.5% fixed combination
Drug: placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00273455

Responsible Party

Study ID Numbers ^ICMJE

PRN 05-017

Study Sponsor ^ICMJE

Pharmaceutical Research Network

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:	William C. Stewart, MD	Pharmaceutical Research Network, LLC
Principal Investigator:	Robert D. Williams, MD	Taustine Eye Center
Principal Investigator:	Robert H. Stewart, MD	Houston Eye Associates
Principal Investigator:	Elizabeth D. Sharpe, MD	Glaucoma Consultants & Center for Eye Research, PA

Information Provided By

Pharmaceutical Research Network

Verification Date

November 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP