Assessing Cosopt Switch Patients

This study has been completed.

Sponsor:

Information provided by:

Pharmaceutical Research Network

ClinicalTrials.gov Identifier:

NCT00273442

First received: January 6, 2006

Last updated: November 18, 2008

Last verified: November 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

January 6, 2006

Last Updated Date

November 18, 2008

Start Date ^ICMJE

November 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00273442 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Assessing Cosopt Switch Patients

Official Title ^ICMJE

Not Provided

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Ocular Hypertension
Open-Angle Glaucoma
Exfoliation Syndrome
Glaucoma, Pigmentary

Intervention ^ICMJE

Drug: timolol maleate
Drug: dorzolamide/timolol maleate fixed combination

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

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 Number ^ICMJE

NCT00273442

Other Study ID Numbers ^ICMJE

PRN 05-007

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Pharmaceutical Research Network

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:	William C. Stewart, MD	Pharmaceutical Research Network, LLC
Principal Investigator:	Mark J. Weiss, MD
Principal Investigator:	Douglas G. Day, MD	Omni Eye Services
Principal Investigator:	Sriram Sonty, MD, FACS	Midwest Eye Center
Principal Investigator:	J. Charles Henry, MD	Little Rock Eye Clinic
Principal Investigator:	Elizabeth D. Sharpe, MD	Glaucoma Consultants & Center for Eye Research

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

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