COSOPT (Timolol/Dorzolamide Combination) Normal Tension Glaucoma Study (MK0507A-161)(COMPLETED)
Primary Purpose
Glaucoma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
timolol/dorzolamide combination
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Timolol/Dorzolamide
Arm Description
Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT00832377
First Posted
January 29, 2009
Last Updated
August 31, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00832377
Brief Title
COSOPT (Timolol/Dorzolamide Combination) Normal Tension Glaucoma Study (MK0507A-161)(COMPLETED)
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 24, 2009 (Actual)
Primary Completion Date
March 12, 2010 (Actual)
Study Completion Date
March 26, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Timolol/Dorzolamide
Arm Type
Experimental
Arm Description
Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
Intervention Type
Drug
Intervention Name(s)
timolol/dorzolamide combination
Other Intervention Name(s)
Cosopt
Intervention Description
Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
Primary Outcome Measure Information:
Title
Mean Change in the Peak Intraocular Pressure (IOP) Measured Two Hours After Study Drug Administration at Week 12 Compared to Baseline IOP.
Description
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.
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Mean Change in Trough IOP Measured Right Before Study Drug Administration at Week 12 Compared to Baseline IOP.
Description
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.
Time Frame
Baseline and 12 weeks
Title
Mean Change in IOP 8 Hours After the Study Drug Administration at Week 12 Compared to Baseline IOP
Description
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.
Time Frame
Baseline and 12 weeks
Other Pre-specified Outcome Measures:
Title
Baseline IOP
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
23377586
Citation
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.
Results Reference
result
Learn more about this trial
COSOPT (Timolol/Dorzolamide Combination) Normal Tension Glaucoma Study (MK0507A-161)(COMPLETED)
We'll reach out to this number within 24 hrs