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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Glaucoma

Treatments: Drug: timolol/dorzolamide combination

Study type: Interventional

Funder types: Industry

Identifiers

NCT00832377

2009_524

0507A-161

Details and patient eligibility

About

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

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Timolol/Dorzolamide

Experimental group

Description:

Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks

Treatment:

Drug: timolol/dorzolamide combination