Travoprost 0.004% in Pediatric Glaucoma Patients

• Research type

  Research Study

• Full title

  A 3-Month, Multi-Center, Double-Masked Safety and Efficacy Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients

• IRAS ID

  120768

• Contact name

  John Brookes

• Sponsor organisation

  Alcon Research Ltd.

• Eudract number

  2012-001324-34

• Clinicaltrials.gov Identifier

  NCT01652664

• Research summary

  The purpose of this research study is to compare the pressure lowering ability of Travoprost Ophthalmic Solution, 0.004% (preserved with POLYQUAD) to Timolol Ophthalmic Solution (0.5% or 0.25%) in pediatric patients with glaucoma. There will be approximately 130 children participating at approximately 60 study sites around the world. Patients will be divided into 2 groups; first group will instil Travoprost 0.004%, the second group will instil Timolol (0.5% or 0.25% depending on the child’s age). Each patient will be assigned to one of the 2 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 the patients are in. In case of any serious problem this information is immediately available to the research doctor. Dosing instructions will be provided with the study medication.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  13/EM/0017

• Date of REC Opinion

  8 Apr 2013

• REC opinion

  Further Information Favourable Opinion