Dry Eye Study With Cosopt® Over 8 Weeks in Patients With Open-Angle Glaucoma or Ocular Hypertension

Condition(s) targeted: Ocular Hypertension; Open Angle Glaucoma

Intervention: dorzolamide hydrochloride (+) timolol maleate (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Merck

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck

To evaluate if preservative free cosopt is well tolerated in patients with Open angle glaucoma (OAG) or Ocular hypertension (OH) with dry eyes.

Official title: A Multicenter, Open-Label Study To Evaluate The Tolerability Of Preservative Free Dorzolamide-Timolol Therapy In Patients Untreated With Open-Angle Glaucoma Or Ocular Hypertension And Dry Eye(S)

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Primary outcome: Change in the incidence and severity of non-visual ocular symptoms as measured by the Glaucoma Symptom Scale (GSS) SYMP-6 scale at baseline and after 12 weeks of treatment with preservative free cosopt

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adult patient with newly diagnosed and untreated for open-angle glaucoma or ocular

hypertension with an IOP of > 27 mmHg (in at least one eye) and a baseline GSS SYMP-6 total score of 75 or less

- Patient is male or a female who is highly unlikely to conceive

- 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 preservative free dorzolamide-timolol (preservative-free Cosopt®)

- 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  preservative-free 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, severe renal impairment (serum creatinine > 150 umol/L or creatinine clearance < 30 ml/min)

- Patient on:

- carbonic anhydrase inhibitor, concomitant systemic or dermatological medication known

to affect the IOP, e. g. clonidine, corticosteroids, oral beta-blocking agents. patient on a non-glaucoma medication that contains a preservative agent, i. e.  benzalkonium chloride, benzododecinium bromide or stabilized oxychloro complex

- Patient with hypersensitivity to any component of preservative free

dorzolamide-timolol (preservative-free Cosopt®)

(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)

Starting date: May 2007
Ending date: December 2007
Last updated: January 4, 2008