A Study to Evaluate the Effectiveness of Cosopt® as First Line Therapy
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Glaucoma Ocular Hypertension |
Drug: dorzolamide hydrochloride (+) timolol maleate Drug: Comparator: dorzolamide HCl/timolol maleate + prostaglandin |
Phase 3 |
| 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: | 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) |
- Reduction in IOP 4 mmHg (or >= 20%) over a period of 6 or 12 weeks. [ Time Frame: 6 to 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 170 |
| Study Start Date: | May 2006 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
dorzolamide HCl/timolol maleate
|
Drug: dorzolamide hydrochloride (+) timolol maleate
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. Other Name: Cosopt
|
|
Experimental: 2
dorzolamide hydrochloride/timolol maleate + prostaglandin
|
Drug: Comparator: dorzolamide HCl/timolol maleate + prostaglandin
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. Other Name: Cosopt
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
More Information
Additional Information:
No publications provided
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
| ClinicalTrials.gov Identifier: | NCT00546286 History of Changes |
| Other Study ID Numbers: | 2007_027, MK0507A-153 |
| Study First Received: | October 16, 2007 |
| Last Updated: | October 27, 2008 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Glaucoma Hypertension Ocular Hypertension Eye Diseases Vascular Diseases Cardiovascular Diseases Timolol Dorzolamide Maleic acid 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 Enzyme Inhibitors Carbonic Anhydrase Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013