A Study to Evaluate the Effectiveness of Cosopt® as First Line Therapy (MK-0507A-153)

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: dorzolamide hydrochloride (+) timolol maleate
* Drug: Comparator: dorzolamide HCl/timolol maleate + prostaglandin


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>dorzolamide HCl/timolol maleate | Drug: dorzolamide hydrochloride (+) timolol maleate<br>* 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.<br>* Other names: Cosopt;|
| Experimental: 2<br>dorzolamide hydrochloride/timolol maleate + prostaglandin | Drug: Comparator: dorzolamide HCl/timolol maleate + prostaglandin<br>* 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.<br>* Other names: Cosopt;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in IOP 4 mmHg (or >= 20%) over a period of 6 or 12 weeks. |  | 6 to 12 weeks |