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

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

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

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Drug: timolol/dorzolamide combination

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Timolol/Dorzolamide; Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks	Drug: timolol/dorzolamide combination; Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks; Other Names: Cosopt

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in the Peak Intraocular Pressure (IOP) Measured Two Hours After Study Drug Administration at Week 12 Compared to Baseline IOP.	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.	Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Trough IOP Measured Right Before Study Drug Administration at Week 12 Compared to Baseline IOP.	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.	Baseline and 12 weeks
Mean Change in IOP 8 Hours After the Study Drug Administration at Week 12 Compared to Baseline IOP	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.	Baseline and 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline IOP	Baseline IOP was measured at ~9 AM of first day of treatment period. IOP was measured in both eyes and the eye with the higher IOP was used for the participant.	Baseline

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Kim TW, Kim M, Lee EJ, Jeoung JW, Park KH. Intraocular pressure-lowering efficacy of dorzolamide/timolol fixed combination in normal-tension glaucoma. J Glaucoma. 2014 Jun-Jul;23(5):329-32. doi: 10.1097/IJG.0b013e3182741f4d.

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2009
• Primary Completion (Actual): March 12, 2010
• Study Completion (Actual): March 26, 2010

Study Registration Dates

• First Submitted: January 29, 2009
• First Submitted That Met QC Criteria: January 29, 2009
• First Posted (Estimate): January 30, 2009

Study Record Updates

• Last Update Posted (Actual): September 29, 2017
• Last Update Submitted That Met QC Criteria: August 31, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Optic Nerve Diseases; Glaucoma; Low Tension Glaucoma; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Enzyme Inhibitors; Carbonic Anhydrase Inhibitors; Timolol; Dorzolamide
• Other Study ID Numbers: 0507A-161; 2009_524

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php