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

NCT00545064 | Completed Phase 4 Results

• 3 other identifiers: 0507A-152MK0507A-1522007_026
• Study Type: interventional
• Target: 176
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate if preservative free cosopt is well tolerated in patients with Open angle glaucoma (OAG) or Ocular hypertension (OH) with dry eyes.

Conditions

Ocular Hypertension; Open Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

• Change in Glaucoma Symptom Scale (GSS)-SYMP-6 Score

  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.

  Baseline to week 8

Other Outcomes (3)

• Patient's Global Satisfaction

  Week 8

• Physician's Global Satisfaction

  Week 8

• 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

  Baseline to Week 4 and from Baseline to Week 8

Interventions

dorzolamide hydrochloride (+) timolol maleate DRUG

dorzolamide hydrochloride (2%)/ timolol maleate (0.5%) Preservative free twice a day (BID), for 8 weeks of treatment

Also known as: MK0507A, Cosopt

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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®)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Hutnik C, Neima D, Ibrahim F, Scott R, Vaillancourt J, Haine D, Sampalis JS, Bastien N, Foucart S. Tolerability and effectiveness of preservative-free dorzolamide-timolol (preservative-free COSOPT) in patients with open-angle glaucoma or ocular hypertension. Clin Ophthalmol. 2010 Jul 21;4:581-90. doi: 10.2147/opth.s10337.

  PMID: 20668720 RESULT

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma, Open-Angle

Interventions

dorzolamide-timolol combination

Condition Hierarchy (Ancestors)

Eye Diseases; Glaucoma

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2007
• First Posted: October 17, 2007
• Study Start: May 23, 2007
• Primary Completion: September 15, 2008
• Study Completion: September 15, 2008
• Last Updated: June 20, 2017
• Results First Posted: February 1, 2010

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share