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

Phase 2

Completed

• Conditions: Glaucoma
• Interventions: Drug: timolol/dorzolamide combination

• Registration Number: NCT00832377
• Lead Sponsor: Merck Sharp & Dohme LLC

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-01-29
• Study First Submitted QC: 2009-01-29
• Study First Posted: 2009-01-30
• Study Start: 2009-04-24
• Primary Completion: 2010-03-12
• Study Completion: 2010-03-26
• Results First Submitted: 2011-02-25
• Results First Submitted QC: 2011-02-25
• Results First Posted: 2011-03-24
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-31
• Last Update Posted: 2017-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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.)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Timolol/Dorzolamide	timolol/dorzolamide combination	Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks

Primary Outcome Measures

Name	Time	Method
Mean Change in the Peak Intraocular Pressure (IOP) Measured Two Hours After Study Drug Administration at Week 12 Compared to Baseline IOP.	Baseline and 12 weeks	The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement.; IOP was measured in both eyes and the eye with the higher IOP was used for the participant.

Secondary Outcome Measures

Name	Time	Method
Mean Change in Trough IOP Measured Right Before Study Drug Administration at Week 12 Compared to Baseline IOP.	Baseline and 12 weeks	The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement.; IOP was measured in both eyes and the eye with the higher IOP was used for the participant.
Mean Change in IOP 8 Hours After the Study Drug Administration at Week 12 Compared to Baseline IOP	Baseline and 12 weeks	The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement.; IOP was measured in both eyes and the eye with the higher IOP was used for the participant.