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

Ocular Hypertension Clinical Trial

— DISCOVER  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545064
• Other study ID #: 0507A-152
• Secondary ID: MK0507A-1522007_
• Status: Completed
• Phase: Phase 4
• First received: October 16, 2007
• Last updated: April 7, 2015
• Start date: May 2007
• Est. completion date: September 2008

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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®)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open Angle Glaucoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & 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 hypertensi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient's Global Satisfaction	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.	Week 8	No
Other	Physician's Global Satisfaction	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.	Week 8	No
Other	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	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.	Baseline to Week 4 and from Baseline to Week 8	No
Primary	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	No

External Links

•   (MedWatch - FDA maintained medical product safety Information)
•   (Merck: Patient & Caregiver U.S. Product Web Site)