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Dry Eye Study With Cosopt® Over 8 Weeks in Patients With Open-Angle Glaucoma or Ocular Hypertension (0507A-152)(COMPLETED) (DISCOVER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00545064
First received: October 16, 2007
Last updated: April 25, 2014
Last verified: April 2014
  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 Sharp & Dohme Corp.:

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.


Other Outcome Measures:
  • Patient's Global Satisfaction [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 176
Study Start Date: May 2007
Study Completion Date: September 2008
Primary Completion Date: September 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545064

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00545064     History of Changes
Other Study ID Numbers: 0507A-152, MK0507A-152, 2007_026
Study First Received: October 16, 2007
Results First Received: August 20, 2009
Last Updated: April 25, 2014
Health Authority: Canada: Canadian Institutes of Health Research

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

ClinicalTrials.gov processed this record on November 24, 2014