Back to resultsAssessing Cosopt Switch Patients
Primary Purpose
Ocular Hypertension, Open-Angle Glaucoma, Exfoliation Syndrome
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
timolol maleate
dorzolamide/timolol maleate fixed combination
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Hypertension
Eligibility Criteria
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
Sites / Locations
- Little Rock Eye Clinic
- Omni Eye Services
- Midwest Eye Center
- Mark J. Weiss, MD
- Glaucoma Consultants & Center for Eye Research
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00273442
First Posted
January 6, 2006
Last Updated
November 18, 2008
Sponsor
Pharmaceutical Research Network
1. Study Identification
Unique Protocol Identification Number
NCT00273442
Brief Title
Assessing Cosopt Switch Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
November 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Open-Angle Glaucoma, Exfoliation Syndrome, Glaucoma, Pigmentary
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
timolol maleate
Intervention Type
Drug
Intervention Name(s)
dorzolamide/timolol maleate fixed combination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Mark J. Weiss, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Douglas G. Day, MD
Organizational Affiliation
Omni Eye Services
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sriram Sonty, MD, FACS
Organizational Affiliation
Midwest Eye Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
J. Charles Henry, MD
Organizational Affiliation
Little Rock Eye Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elizabeth D. Sharpe, MD
Organizational Affiliation
Glaucoma Consultants & Center for Eye Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Little Rock Eye Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Omni Eye Services
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Midwest Eye Center
City
Bourbonnais
State/Province
Illinois
ZIP/Postal Code
60914
Country
United States
Facility Name
Mark J. Weiss, MD
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Glaucoma Consultants & Center for Eye Research
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
12. IPD Sharing Statement
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Assessing Cosopt Switch Patients
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