Status:
COMPLETED
COSOPT (Timolol/Dorzolamide Combination) Normal Tension Glaucoma Study (MK0507A-161)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 24 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2010
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00832377
Start Date
April 24 2009
End Date
March 26 2010
Last Update
September 29 2017
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