Brinz/Brim BID FC vs Brinzolamide BID and Brimonidine BID

• Research type

  Research Study

• Full title

  Safety and IOP-Lowering Efficacy of Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL Fixed Combination Eye Drops, Suspension compared to Brinzolamide 10 mg/mL Eye Drops, Suspension and Brimonidine 2 mg/mL Eye Drops, Solution in Patients with Open-Angle Glaucoma or Ocular Hypertension

• IRAS ID

  77133

• Contact name

  Keith Barton

• Sponsor organisation

  Alcon Italia S.p.A.

• Eudract number

  2010-024512-34

• ISRCTN Number

  1

• Research summary

  The purpose of this research study is to compare the side effects and eye-Pressure lowering ability of a fixed combination of brinzolamide 10 mg/ml / brimonidine 2 mg/ml eye drops suspension administered two times daily to: Brinzolamide 10 mg/mL eye drops, suspension (eye drops dosed 2 times daily), and Brimonidine 2 mg/mL eye drops, solution (eye drops dosed 2 times daily). Approximately 525 men and women will take part in this research that is being conducted worldwide. Patients will be divided into 3 groups; first group will instil Brinz/Brim, second group will instil Brinzolamide, and the third group Brimonidine. Each patient will be assigned to one of the 3 groups by chance, through a procedure similar to tossing a coin. The study will remain masked so that neither patient nor research doctor will know which group patient are in. In case of any serious problem this information is immediately available to the research doctor. The masking will be complete also for what the eye drops appearance is concerned as all patients will instil a suspension and a solution, at least 10 minutes apart. Dosing instructions will be provided with the study medication.

• REC name

  Wales REC 2

• REC reference

  11/WA/0084

• Date of REC Opinion

  15 Apr 2011

• REC opinion

  Favourable Opinion