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

• ClinicalTrials.gov Identifier: NCT00832377
• Recruitment Status: Completed
• First Posted: January 30, 2009
• Results First Posted: March 24, 2011
• Last Update Posted: September 29, 2017
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Study Description

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

Condition or disease	Intervention/treatment	Phase
Glaucoma	Drug: timolol/dorzolamide combination	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 37 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: April 24, 2009
• Actual Primary Completion Date: March 12, 2010
• Actual Study Completion Date: March 26, 2010

Arms and Interventions

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 Name: Cosopt

Outcome Measures

Primary Outcome Measures :

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

1. Mean Change in Trough IOP Measured Right Before Study Drug Administration at Week 12 Compared to Baseline IOP. [ Time Frame: 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.

2. Mean Change in IOP 8 Hours After the Study Drug Administration at Week 12 Compared to Baseline IOP [ Time Frame: 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.

Other Outcome Measures:

1. Baseline IOP [ Time Frame: Baseline ]

   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.

Eligibility Criteria

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

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

Contacts and Locations

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

• Study Director: Medical Monitor; Merck Sharp & Dohme Corp.

More Information

Publications of Results:

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.

• Responsible Party: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT00832377
• Other Study ID Numbers: 0507A-161; 2009_524
• First Posted: January 30, 2009
• Results First Posted: March 24, 2011
• Last Update Posted: September 29, 2017
• Last Verified: August 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

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

Additional relevant MeSH terms:

Glaucoma; Low Tension Glaucoma; Ocular Hypertension; Eye Diseases; Optic Nerve Diseases; Timolol; Dorzolamide; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Antihypertensive Agents; Carbonic Anhydrase Inhibitors; Enzyme Inhibitors