Bimatoprost 0.03% Preservative-free Ophthalmic Solution in Paediatric

• Research type

  Research Study

• Full title

  A Multicenter, Double-masked, Randomized, Active-controlled, Parallel Study of the Safety and Efficacy of Once-daily Bimatoprost Preservative-free Ophthalmic Solution Compared to Twice-daily Timolol Ophthalmic Solution in Paediatric Patients With Glaucoma

• IRAS ID

  86436

• Contact name

  Annegret Dahlmann-Noor

• Sponsor organisation

  Allergan Ltd.

• Eudract number

  2011-003278-10

• ISRCTN Number

  n/a

• Research summary

  Allergan is developing a preservative-free formulation of Lumigan. LUMIGAN© (bimatoprost 0.03% ophthalmic solution, hereafter referred to as LUMIGAN© 0.03%) is a well established effective eye pressure (Intra Ocular Pressure-IOP) lowering therapy for glaucoma. The preservative-free (PF) formulation of LUMIGAN differs from LUMIGAN only in that benzalkonium chloride (BAK) has been removed. This study is being conducted to establish the potential role of bimatoprost 0.03% preservative-free in the management of glaucoma in paediatric patients in whom surgical intervention is not indicated. The study population consists of paediatric patients and young adults aged 2 months - <16 years and 16 - <18 years. Paediatric patients who are eligible for entry based on the inclusion and exclusion criteria specified in the protocol will be randomised in 1:1 ratio to receive either a once-daily preservative-free bimatoprost 0.03% PF or twice-daily timolol ophthalmic solution in one or both eyes. Timolol 0.5% will be used as the control treatment in patients aged 12 to < 18 years; timolol 0.25% will be used as the control treatment in patients aged < 12 years. Bimatoprost vehicle will be used for masking purposes. Study medication will be administered as 1 drop in each eye to be treated in the morning and in the evening. Patients in the bimatoprost group will receive active medication in the evening and bimatoprost vehicle in the morning; patients in the timolol group will receive active medication in the evening and the morning. At the completion of the 12-week treatment period, patients will be followed up for 9 additional months. The primary efficacy measure is IOP and the primary time point is at 12 weeks. At least 80 patients and up to 84 patients will be enrolled at approximately 30 sites worldwide in order to have an estimated 76 patients complete the study.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  11/LO/1658

• Date of REC Opinion

  5 Dec 2011

• REC opinion

  Further Information Favourable Opinion