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

Condition(s) targeted: Glaucoma

Intervention: timolol/dorzolamide combination (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

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

Official title: Prospective, Open-label, Single-arm Study to Evaluate Efficacy and Safety of Combination Therapy of Timolol and Dorzolamide (COSOPT) as Initial Treatment for Patients With Normal Tension Glaucoma

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

Primary outcome: Mean Change in the Peak Intraocular Pressure (IOP) Measured Two Hours After Study Drug Administration at Week 12 Compared to Baseline IOP.

Secondary outcome:

Mean Change in Trough IOP Measured Right Before Study Drug Administration at Week 12 Compared to Baseline IOP.

Mean Change in IOP 8 Hours After the Study Drug Administration at Week 12 Compared to Baseline IOP

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

MedWatch - FDA maintained medical product safety Information

Merck: Patient & Caregiver U.S. Product Web Site

Starting date: April 2009
Last updated: February 6, 2015