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)”

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).

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: dorzolamide hydrochloride (+) timolol maleate /
  • dorzolamide hydrochloride (2%)/ timolol maleate (0.5%) BID, for 8 Weeks of Treatment.

Primary Measures

• Reduction in Inter Ocular Pressure 4 mmHg (or >/= 20%) over a period of 6 to 12 weeks
  • Time Frame: 6 to 12 weeks
    Safety Issue?: 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 VI), 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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00546286

Study ID Number: 2007_027

ClinicalTrials.gov Identifier: NCT00546286

Health Authority: Canada: Canadian Institutes of Health Research

(MedWatch - FDA maintained medical product safety Information)

(PhRMA Clinical Study Results Database - web-based repository for clinical study results)

(Merck: Patient & Caregiver U.S. Product Web Site)