Dry Eye Study With Cosopt® Over 8 Weeks in Patients With Open-Angle Glaucoma or Ocular Hypertension (DISCOVER)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00545064
First received: October 16, 2007
Last updated: April 20, 2010
Last verified: April 2010
  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
    dorzolamide hydrochloride (2%)/ timolol maleate (0.5%) Preservative free twice a day (BID), for 8 weeks of treatment
    Other Names:
    • MK0507A
    • Cosopt
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545064

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  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