Back to resultsA Study to Evaluate the Effectiveness of Cosopt® as First Line Therapy (MK-0507A-153)
Primary Purpose
Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
dorzolamide hydrochloride (+) timolol maleate
Comparator: dorzolamide HCl/timolol maleate + prostaglandin
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Patient has been recently diagnosed and is presently untreated for Open-Angle Glaucoma Or Ocular Hypertension With An iop of at least 27 mmhg in at least one eye (patient's worse eye)
- Patient Already Diagnosed With Open-Angle Glaucoma Or Ocular Hypertension And Untreated For At Least 30 Days Are Eligible For The Study If They Have An Iop Of 27 Mmhg Or More In At Least One Eye
Exclusion Criteria:
- A History Of Any Illness That, In The Opinion Of The Investigator, Might Confound The Results Of The Study Or Pose Additional Risk By Administering Dorzolamide-Timolol (Cosopt®) Or Prostaglandins
- The Presence Of Any Fundus Pathology Likely To Change During The Study Or To Influence Iop (Background Of Diabetic Retinopathy Is Permitted)
- Any Contraindication To The Use Of Cosopt® Including: - Bronchospasm, Including Bronchial Asthma Or A History Of Bronchial Asthma Or Chronic Obstructive Pulmonary Disease. - Sinus Bradycardia, Second Or Third Degree Av Block, Cardiac Failure (Grade Iii And Iv), Cardiogenic Shock
- Patient On Oral Carbonic Anhydrase Inhibitor, Concomitant Systemic Or Dermatological Medication Known To Affect The Iop, E.G. Clonidine, Corticosteroids, Oral Beta-Blocking Agents
- Pregnant Woman Or A Woman Of Childbearing Potential Who Is Sexually Active And Not Using An Acceptable Method Of Contraception (For Ex: Oral Contraceptive, Diaphragm, Contraceptive Sponge, Intra-Uterine Device, Long-Acting Contraceptive Injections, Double-Barrier Methods) Beginning At Least 7 Days Prior To Treatment And Continuing At Least 14 Days After The Last Visit Or The Discontinuation Visit. (Women Who Are Postmenopausal Or Have Received A Hysterectomy Or Have Undergone Tubal Ligature Are Considered As Not Having Childbearing Potential.)
- Severe Renal Impairment (Serum Creatinine > 150 umol/L Or Creatinine Clearance < 30 ml/min)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
dorzolamide HCl/timolol maleate
dorzolamide hydrochloride/timolol maleate + prostaglandin
Outcomes
Primary Outcome Measures
Reduction in IOP 4 mmHg (or >= 20%) over a period of 6 or 12 weeks.
Secondary Outcome Measures
Full Information
NCT ID
NCT00546286
First Posted
October 16, 2007
Last Updated
March 31, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00546286
Brief Title
A Study to Evaluate the Effectiveness of Cosopt® as First Line Therapy (MK-0507A-153)
Official Title
A 12 Week, Open-Label, Study to Evaluate the Effectiveness of Dorzolamide-Timolol as First Line Therapy to Reduce Intraocular Pressure in Patients With Untreated Open Angle Glaucoma (OAG) or Ocular Hypertension (OH)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 31, 2006 (Actual)
Primary Completion Date
August 23, 2007 (Actual)
Study Completion Date
August 23, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
Evaluate the effectiveness of dorzolamide-timolol (Cosopt®) as first line therapy in reducing intraocular pressure in patients with untreated Open angle glaucoma (OAG) or Ocular hypertension (OH).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
dorzolamide HCl/timolol maleate
Arm Title
2
Arm Type
Experimental
Arm Description
dorzolamide hydrochloride/timolol maleate + prostaglandin
Intervention Type
Drug
Intervention Name(s)
dorzolamide hydrochloride (+) timolol maleate
Other Intervention Name(s)
Cosopt
Intervention Description
Combination treatment of dorzolamide HCl (2%)/ timolol maleate (0.5%) BID for six weeks in patients with open-angle glaucoma or ocular hypertension.
For patients who achieve target IOP at 6 weeks, dorzolamide/timolol is continued for another 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Comparator: dorzolamide HCl/timolol maleate + prostaglandin
Other Intervention Name(s)
Cosopt
Intervention Description
Combination treatment of dorzolamide HCl (2%)/timolol maleate(0.5%) BID for six weeks in patients with open-angle glaucoma or ocular hypertension.
For patients not achieving target IOP at 6 weeks, a prostaglandin is added for another 6 weeks.
Primary Outcome Measure Information:
Title
Reduction in IOP 4 mmHg (or >= 20%) over a period of 6 or 12 weeks.
Time Frame
6 to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient has been recently diagnosed and is presently untreated for Open-Angle Glaucoma Or Ocular Hypertension With An iop of at least 27 mmhg in at least one eye (patient's worse eye)
Patient Already Diagnosed With Open-Angle Glaucoma Or Ocular Hypertension And Untreated For At Least 30 Days Are Eligible For The Study If They Have An Iop Of 27 Mmhg Or More In At Least One Eye
Exclusion Criteria:
A History Of Any Illness That, In The Opinion Of The Investigator, Might Confound The Results Of The Study Or Pose Additional Risk By Administering Dorzolamide-Timolol (Cosopt®) Or Prostaglandins
The Presence Of Any Fundus Pathology Likely To Change During The Study Or To Influence Iop (Background Of Diabetic Retinopathy Is Permitted)
Any Contraindication To The Use Of Cosopt® Including: - Bronchospasm, Including Bronchial Asthma Or A History Of Bronchial Asthma Or Chronic Obstructive Pulmonary Disease. - Sinus Bradycardia, Second Or Third Degree Av Block, Cardiac Failure (Grade Iii And Iv), Cardiogenic Shock
Patient On Oral Carbonic Anhydrase Inhibitor, Concomitant Systemic Or Dermatological Medication Known To Affect The Iop, E.G. Clonidine, Corticosteroids, Oral Beta-Blocking Agents
Pregnant Woman Or A Woman Of Childbearing Potential Who Is Sexually Active And Not Using An Acceptable Method Of Contraception (For Ex: Oral Contraceptive, Diaphragm, Contraceptive Sponge, Intra-Uterine Device, Long-Acting Contraceptive Injections, Double-Barrier Methods) Beginning At Least 7 Days Prior To Treatment And Continuing At Least 14 Days After The Last Visit Or The Discontinuation Visit. (Women Who Are Postmenopausal Or Have Received A Hysterectomy Or Have Undergone Tubal Ligature Are Considered As Not Having Childbearing Potential.)
Severe Renal Impairment (Serum Creatinine > 150 umol/L Or Creatinine Clearance < 30 ml/min)
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
Citations:
PubMed Identifier
20874498
Citation
Crichton AC, Harasymowycz P, Hutnik CM, Behki R, Boucher S, Ibrahim F, Rifkind AW, Solomon L, Liao C, Bastien NR, Sampalis JS. Effectiveness of dorzolamide-timolol (COSOPT) in patients who were treatment naive for open-angle glaucoma or ocular hypertension: the COSOPT first-line study. J Ocul Pharmacol Ther. 2010 Oct;26(5):503-11. doi: 10.1089/jop.2010.0032.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
A Study to Evaluate the Effectiveness of Cosopt® as First Line Therapy (MK-0507A-153)
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