* CSAF312B12201

• Research type

  Research Study

• Full title

  A 12-week parallel group, randomized, placebo-controlled, doubleblinded, multi-center study to evaluate efficacy and safety of 2 concentrations of SAF312 eye drops (5 mg/ml and 15 mg/ml) used twice-daily in the treatment of post-operative corneal induced chronic pain (CICP) following Photorefractive Keratectomy (PRK) or Laser assisted in Situ Keratomileusis (LASIK) surgeries

• IRAS ID

  1004620

• Contact name

  Helen Sun

• Contact email

  helen-1.sun@novartis.com

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2021-005857-97

• Clinicaltrials.gov Identifier

  NCT04630158

• Research summary

  The purpose of this study is to demonstrate the safety and efficacy of two dose concentrations of SAF312 eye drops in subjects with corneal induced chronic pain persisiting for at least four months after refractive or cataract surgery. The study will also determine the optimal dose to carry forward for further development. The study will be run at 3 centres in the UK.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  22/SC/0318

• Date of REC Opinion

  31 Mar 2022

• REC opinion

  Further Information Favourable Opinion