Patient Preference Comparison of AZARGA Versus COSOPT

The purpose of this study is to assess patient preference of AZARGA® compared to COSOPT® after one week instillation of each study medication is administered to both eyes in patients with open-angle glaucoma or ocular hypertension.

• Drug: Brinzolamide/Timolol Maleate Fixed Combination (Azarga)
  Brinzolamide/timolol maleate fixed combination, one drop instilled in one eye at baseline, followed by one drop instilled in each eye twice a day for seven days in either first intervention period or second intervention period.
  Other Name: Azarga
• Drug: Dorzolamide/Timolol Maleate Fixed Combination (Cosopt)
  Dorzolamide/timolol maleate fixed combination, one drop instilled in one eye at baseline, followed by one drop instilled in each eye twice a day for seven days in either first intervention period or second intervention period.
  Other Name: Cosopt

• Active Comparator: Azarga/Cosopt
  Following administration of the baseline dose (each intervention instilled in one eye in a contralateral fashion to establish baseline ocular comfort for each medication), Azarga will be instilled one drop in both eyes twice a day for seven days. After a 48 hour washout period, Cosopt will then be instilled one drop in both eyes twice a day for the next seven days.
  Interventions:

  • Drug: Brinzolamide/Timolol Maleate Fixed Combination (Azarga)
  • Drug: Dorzolamide/Timolol Maleate Fixed Combination (Cosopt)
• Active Comparator: Cosopt/Azarga
  Following administration of the baseline dose (each intervention instilled in one eye in a contralateral fashion to establish baseline ocular comfort for each medication), Cosopt will be instilled one drop in both eyes twice a day for seven days. After a 48 hour washout period, Azarga will then be instilled one drop in both eyes twice a day for the next seven days.
  Interventions:

  • Drug: Brinzolamide/Timolol Maleate Fixed Combination (Azarga)
  • Drug: Dorzolamide/Timolol Maleate Fixed Combination (Cosopt)

Inclusion Criteria:

• 18 years of age or older.
• Clinical diagnosis of ocular hypertension, open-angle with our without pseudoexfoliation or pigment dispersion glaucoma in both eyes.
• Be on a stable regimen of intraocular pressure-lowering (IOP) medication within 30 days of Screening visit.
• Be willing to discontinue the use of all other ocular drugs (prescribed and over-the-counter) prior to receiving the screening dose during the screening visit and for the entire course of the study.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Known medical history of allergy, hypersensitivity or poor tolerance to any component of the preparations to be used in this study that is deemed clinically significant in the opinion of the principal investigator.
• Best corrected visual acuity worse than 20/80 Snellen in either eye.
• Corneal dystrophies in either eye.
• Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
• Bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
• History of severe allergic rhinitis.
• Participation in any other investigational study within 30 days prior to the Screening/baseline Visit.
• Other protocol-defined exclusion criteria may apply.