Dry Eye Study With Cosopt® Over 8 Weeks in Patients With Open-Angle Glaucoma or Ocular Hypertension (0507A-152)(COMPLETED)
Condition: Ocular Hypertension; Open Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: dorzolamide hydrochloride (+) timolol maleate
Intervention description: dorzolamide hydrochloride (2%)/ timolol maleate (0.5%) Preservative free twice a day (BID), for 8 weeks of treatment
Intervention MeSH terms: Timolol; Dorzolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 176.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        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®)