COSOPT (Timolol/Dorzolamide Combination) Normal Tension Glaucoma Study (MK0507A-161)(COMPLETED)

• Status: Completed
• Trial end date: 2010-03-26
• Target enrollment: 0
• Participant gender: All

Summary

A study to evaluate the effect of the 12-week treatment with timolol/dorzolamide combination eyedrops (COSOPT) on decrease in intraocular pressure (IOP) at 2 hours after the study drug administration

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Dorzolamide; Timolol

Criteria

Inclusion Criteria:

• Patients who have not been treated with a glaucoma medication within 6 weeks prior to study participation after diagnosis with primary open-angle glaucoma

• Patients with primary open-angle glaucoma based on gonioscopy

• Patients with normal tension glaucoma diagnosed based on accompanying optic disc cupping and reappearance of visual field defect corresponding to retinal nerve fiber layer defect.

• Subjects with < 22 mm Hg of diurnal IOP measured using Goldmann applanation tonometer (every two hours between 9 a.m. and 5 p.m.)

Exclusion Criteria:

• Patients with another type of glaucoma but primary open-angle glaucoma

• Patients treated with other glaucoma medications within 6 weeks prior to study participation

• Patients with a history of chronic ocular inflammation or recurrent ocular inflammation

• Patients using contact lenses

• Patients who are allergic to timolol or dorzolamide

• Patients with a history of any of the following COSOPT (timolol/dorzolamide combination) contraindications:

• Reactive airway diseases

• Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock

• Severe renal impairment

• Patients with a history of significant ocular trauma or intraocular surgery within 6 months before participating the study, or intraocular laser surgery within 3 months before the participating the study

• Patients with a history of a corneal disease

• Patients who are using steroid or used the drug for more than 2 weeks within 12 months before participating the study

• Pregnant women