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OpenTrials
Completed

NCT Number: NCT00832377

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

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

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

timolol/dorzolamide combination

Drug

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

Other names: Cosopt

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 30, 2009
Registry last updated
Sep 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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