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Dry Eye Study With Cosopt® Over 8 Weeks in Patients With Open-Angle Glaucoma or Ocular Hypertension (DISCOVER)
This study has been completed.
First Received: October 16, 2007   Last Updated: September 8, 2008   History of Changes
Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00545064
  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 IV

Genetics Home Reference related topics: early-onset glaucoma
MedlinePlus related topics: Glaucoma High Blood Pressure
Drug Information available for: Timolol Timolol maleate Dorzolamide Dorzolamide hydrochloride Cosopt
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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)

Further study details as provided by Merck:

Primary Outcome Measures:
  • Change in the incidence and severity of non-visual ocular symptoms as measured by the Glaucoma Symptom Scale (GSS) SYMP-6 scale at baseline and after 12 weeks of treatment with preservative free cosopt [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 170
Study Start Date: May 2007
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 BID, for 12 weeks of treatment
  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 IOP of > 27 mmHg (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 mmHg 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 mmHg 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: Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2007_026, MK0507A-152
Study First Received: October 16, 2007
Last Updated: September 8, 2008
ClinicalTrials.gov Identifier: NCT00545064     History of Changes
Health Authority: Canada: Canadian Institutes of Health Research

Study placed in the following topic categories:
Neurotransmitter Agents
Adrenergic Agents
Eye Diseases
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Glaucoma
Glaucoma, Open-Angle
Adrenergic beta-Antagonists
Adrenergic Antagonists
Timolol
Anti-Arrhythmia Agents
Ocular Hypertension
Hypertension
Dorzolamide

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Eye Diseases
Physiological Effects of Drugs
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Glaucoma
Therapeutic Uses
Glaucoma, Open-Angle
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Anti-Arrhythmia Agents
Timolol
Hypertension
Ocular Hypertension
Dorzolamide

ClinicalTrials.gov processed this record on May 06, 2009