Overview

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

Status:
Completed
Trial end date:
2007-08-23
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Dorzolamide
Maleic acid
Timolol
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)