A6111137 Latanoprost and Timolol in Paediatric Subjects with Glaucoma

• Research type

  Research Study

• Full title

  A6111137 A Phase 3, Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study Evaluating the Efficacy and Safety of Latanoprost and Timolol in Paediatric Subjects With Glaucoma.

• Sponsor organisation

  Pfizer Ltd

• Eudract number

  2007-004543-30

• ISRCTN Number

  N/A

• Research summary

  Latanoprost is used for thetreatment of glaucoma and ocular hypertension in adults. Although not approvedfor use in children, it is acknowledged that off-label use of the adult dose iscommon despite a lack of controlled data or clear guidance for pediatric use.In this protocol, latanoprost is being investigated to confirm efficacy and safetyin paediatric subjects with glaucoma. The goal of this study is to provideclinical guidance for the use of latanoprost for paediatric glaucoma. This is aprospective, randomized, double masked, 12 week treatment phase, parallel groupstudy of latanoprost and timolol in paediatric subjects <18 years of age.The primary objective is to assess the relative effectiveness of latanoprostand timolol in paediatric subjects <18 years of age who are diagnosed withpaediatric glaucoma. Approximately 120 subjects will be enrolled between theages of 0 and <18 years grouped by age (0 to <3 years, 3 to <12 years,12 to <18 years). Recruitment will begin in the older group after confirmedin the other study that systemic exposure is not higher than expected, and thenenrollment of next age group will follow. All eligible subjects will berandomized in a 1:1 ratio (latanoprost vs. timolol). Parents or legal guardians(primary caretaker) of patients should administer one drop of study medicationin the affected eye(s) once daily in the morning and once daily in the eveningfor the 84 day treatment duration. All products will be dosed according toapproved labeling for adults. The study is being funded by Pfizer Inc. and isbeing conducted in approximately 74 sites in 23 countries.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  08/H1005/96

• Date of REC Opinion

  24 Nov 2008

• REC opinion

  Further Information Favourable Opinion