Assessing Cosopt Switch Patients

Sponsor

Pharmaceutical Research Network (Other)

Overall Status

Completed

CT.gov ID

NCT00273442

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ocular Hypertension Open-Angle Glaucoma Exfoliation Syndrome Glaucoma, Pigmentary	Drug: timolol maleate Drug: dorzolamide/timolol maleate fixed combination	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Nov 1, 2005

Actual Study Completion Date :

Apr 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Little Rock Eye Clinic	Little Rock	Arkansas	United States	72205
2	Omni Eye Services	Atlanta	Georgia	United States	30342
3	Midwest Eye Center	Bourbonnais	Illinois	United States	60914
4	Mark J. Weiss, MD	Tulsa	Oklahoma	United States	74104
5	Glaucoma Consultants & Center for Eye Research	Mt. Pleasant	South Carolina	United States	29464

Sponsors and Collaborators

Pharmaceutical Research Network

Investigators

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