Dry Eye Study With Cosopt® Over 8 Weeks in Patients With Open-Angle Glaucoma or Ocular Hypertension (DISCOVER)
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00545064
First received: October 16, 2007
Last updated: April 20, 2010
Last verified: April 2010
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
To evaluate if preservative free cosopt is well tolerated in patients with Open angle glaucoma (OAG) or Ocular hypertension (OH) with dry eyes.
| Condition | Intervention | Phase |
|---|---|---|
|
Ocular Hypertension Open Angle Glaucoma |
Drug: dorzolamide hydrochloride (+) timolol maleate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Change in Glaucoma Symptom Scale (GSS)-SYMP-6 Score [ Time Frame: Baseline to week 8 ] [ Designated as safety issue: No ]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.
| Enrollment: | 176 |
| Study Start Date: | May 2007 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: dorzolamide hydrochloride (+) timolol maleate
- MK0507A
- Cosopt
dorzolamide hydrochloride (2%)/ timolol maleate (0.5%) Preservative free twice a day (BID), for 8 weeks of treatment
Other Names:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patient with newly diagnosed and untreated for open-angle glaucoma or ocular hypertension with an Intra-ocular Pressure (IOP) of > 27 mm Hg (in at least one eye) and a baseline GSS SYMP-6 total score of 75 or less
- Patient is male or a female who is highly unlikely to conceive
- Patient has been recently diagnosed and is presently untreated for open-angle glaucoma or ocular hypertension with an IOP of at least 27 mm Hg in at least one eye (patient's worse eye)
- Patient already diagnosed with open-angle glaucoma or ocular hypertension and untreated for at least 30 days are eligible for the study if they have an IOP of 27 mm Hg or more in at least one eye
Exclusion Criteria:
- A history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk by administering preservative free dorzolamide-timolol (preservative-free Cosopt®)
- The presence of any fundus pathology likely to change during the study or to influence IOP (background of diabetic retinopathy is permitted)
- Any contraindication to the use of preservative-free Cosopt® including:
- bronchospasm, including bronchial asthma or a history of bronchial asthma or chronic obstructive pulmonary disease, sinus bradycardia, second or third degree AV block, cardiac failure (grade III and IV), cardiogenic shock, severe renal impairment (serum creatinine > 150 umol/L or creatinine clearance < 30 ml/min)
- Patient on:
- carbonic anhydrase inhibitor, concomitant systemic or dermatological medication known to affect the IOP, e.g. clonidine, corticosteroids, oral beta-blocking agents. patient on a non-glaucoma medication that contains a preservative agent, i.e. benzalkonium chloride, benzododecinium bromide or stabilized oxychloro complex
- Patient with hypersensitivity to any component of preservative free dorzolamide-timolol (preservative-free Cosopt®)
Contacts and Locations
More Information
Additional Information:
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 |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle Hypertension Ocular Hypertension Eye Diseases Vascular Diseases Cardiovascular Diseases Timolol Dorzolamide Maleic acid Adrenergic beta-Antagonists Adrenergic Antagonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Antihypertensive Agents Enzyme Inhibitors Carbonic Anhydrase Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013