Dry Eye Study With Cosopt® Over 8 Weeks in Patients With Open-Angle Glaucoma or Ocular Hypertension (0507A-152)(COMPLETED) (DISCOVER)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 4

Conditions

Open Angle Glaucoma

Ocular Hypertension

Treatments

Drug: dorzolamide hydrochloride (+) timolol maleate

Study type

Interventional

Funder types

Industry

Identifiers

0507A-152

2007_026

MK0507A-152

Details and patient eligibility

About

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

Enrollment

176 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult patient with newly diagnosed and untreated for open-angle glaucoma or ocular hypertension with an Intra-ocular Pressure (IOP) of > 27 mm Hg (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 mm Hg 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 mm Hg 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®)