Full Text View
Tabular View
Study Results
Related Studies
Dry Eye Study With Cosopt® Over 8 Weeks in Patients With Open-Angle Glaucoma or Ocular Hypertension (DISCOVER)
This study has been completed.
Study NCT00545064   Information provided by Merck

First Received on October 16, 2007.   Last Updated on April 20, 2010   History of Changes
Results First Received: August 20, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Ocular Hypertension
Open Angle Glaucoma
Intervention: Drug: dorzolamide hydrochloride (+) timolol maleate

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First patient in: MAY-23-2007 Last patient out: OCT-15-2008 Total number of sites: 28 sites in Canada. (Study performed in Canada only).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Preservative-free Dorzolamide-timolol (COSOPT®)

subjects received preservative-free dorzolamide-timolol (COSOPT®) administered one drop in the affected eye two times daily

The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristircs were available).

Participant Flow:   Overall Study
    Preservative-free Dorzolamide-timolol (COSOPT®)  
STARTED     178  
Visit 1 (Baseline)     178  
Visit 2 (Week 4)     169  
Visit 3 (Week 8)     176 [1]
COMPLETED     170  
NOT COMPLETED     8  
Lost to Follow-up                 3  
Withdrawal by Subject                 2  
did not complete course of treatment                 1  
cancel all appointments, no rebooking                 1  
inclement weather                 1  
[1] 8 patients didn’t complete the 8-week period. 6 were retrieved and considered as Visit 3 (Week 8)



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Preservative-free Dorzolamide-timolol (COSOPT®)

subjects received preservative-free dorzolamide-timolol (COSOPT®) administered one drop in the affected eye two times daily

The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristircs were available).

Baseline Measures
    Preservative-free Dorzolamide-timolol (COSOPT®)  
Number of Participants  
[units: participants]
 		  178  
Age  
[units: years]
Mean ± Standard Deviation 		  65.6  ± 12.1  
Gender  
[units: participants]
 		 
Female     90  
Male     88  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Glaucoma Symptom Scale (GSS)-SYMP-6 Score   [ Time Frame: Baseline to week 8 ]
  Show Outcome Measure 1

2.  Other Pre-specified:   Patient’s Global Satisfaction   [ Time Frame: Week 8 ]
  Show Outcome Measure 2

3.  Other Pre-specified:   Physician’s Global Satisfaction   [ Time Frame: Week 8 ]
  Show Outcome Measure 3

4.  Other Pre-specified:   Change in Intra-ocular Pressure (IOP) for Worse Eye From Baseline to Week 4 and From Baseline to Week 8, in Patients Receiving Preservative-free Dorzolamide-timolol   [ Time Frame: Baseline to Week 4 and from Baseline to Week 8 ]
  Show Outcome Measure 4


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


No publications provided


Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00545064     History of Changes
Other Study ID Numbers: 2007_026, MK0507A-152
Study First Received: October 16, 2007
Results First Received: August 20, 2009
Last Updated: April 20, 2010
Health Authority: Canada: Canadian Institutes of Health Research





Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services