Dry Eye Study With Cosopt® Over 8 Weeks in Patients With Open-Angle Glaucoma or Ocular Hypertension (0507A-152)(COMPLETED) (DISCOVER)
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|ClinicalTrials.gov Identifier: NCT00545064|
Recruitment Status : Completed
First Posted : October 17, 2007
Results First Posted : February 1, 2010
Last Update Posted : June 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Ocular Hypertension Open Angle Glaucoma||Drug: dorzolamide hydrochloride (+) timolol maleate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||176 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-Label Study To Evaluate The Tolerability Of Preservative Free Dorzolamide-Timolol Therapy In Patients Untreated With Open-Angle Glaucoma Or Ocular Hypertension And Dry Eye(s)|
|Actual Study Start Date :||May 23, 2007|
|Actual Primary Completion Date :||September 15, 2008|
|Actual Study Completion Date :||September 15, 2008|
U.S. FDA Resources
Drug: dorzolamide hydrochloride (+) timolol maleate
- Change in Glaucoma Symptom Scale (GSS)-SYMP-6 Score [ Time Frame: Baseline to week 8 ]GSS-SYMP-6 measures 6 non-visual adverse symptoms related to glaucoma medications, with 10 5-point Likert scale questions. Score ranges between 0 and 100, lower scores indicating higher symptoms severity. Change equals post-baseline value minus baseline.
- Patient's Global Satisfaction [ Time Frame: Week 8 ]At week 8, patients were asked to complete a single question describing how satisfied they were regarding with their medication, on a 5-level scale: very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, very dissatisfied.
- Physician's Global Satisfaction [ Time Frame: Week 8 ]At week 8, physicians were asked to complete a single question describing how satisfied they were regarding their patient's treatment, on a 5-level scale: very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, very dissatisfied.
- 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 ]IOP measurements using Goldmann applanation tonometry, performed by a masked physician two hours after patient was administered study medication. Change is computed as week 4 (or week 8) value minus baseline value.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00545064
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|