COSOPT (Timolol/Dorzolamide Combination) Normal Tension Glaucoma Study (MK0507A-161)(COMPLETED)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Glaucoma |
Drug: timolol/dorzolamide combination |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- 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 ] [ Designated as safety issue: No ]
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 Trough IOP Measured Right Before Study Drug Administration at Week 12 Compared to Baseline IOP. [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
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.
| Enrollment: | 37 |
| Study Start Date: | April 2009 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 More Information
Additional Information:
No publications provided
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00832377 History of Changes |
| Other Study ID Numbers: | MK-0507A-161, 2009_524 |
| Study First Received: | January 29, 2009 |
| Results First Received: | February 25, 2011 |
| Last Updated: | February 25, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
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 Pharmacologic Actions Physiological Effects of Drugs Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Antihypertensive Agents Carbonic Anhydrase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013