Back to Results

SAHARA

Title A 12-week parallel group, randomized, placebo-controlled, double-blinded, multi-center study to evaluate efficacy and safety of 2 concentrations of SAF312 eye drops (5mg/ml and 15mg/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
Therapeutic Area Corneal Pain, Corneal Disorders
Principal Investigator Helen Wu, MD
Min Age 18 Years
Max Age 110 Years
Gender Any
Contact Nancy Gee
617-636-5489
ngee@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04630158

Overview

The study is designed to demonstrate the safety and efficacy of two dose concentrations of SAF312 eye drops (dose 1 [5 mg/ml] and dose 2 [15 mg/ml]) in subjects with chronic induced corneal pain (CICP) persisting at least for 4 months after refractive surgery and chronicity confirmed during the observational period. The study will also determine the optimal dose to carry forward for further development.

Study Details

Inclusion Criteria

  • Subjects who have undergone PRK or LASIK surgery in both eyes ≥4 months prior to Screening Visit and experiencing persistent ocular surface pain since the surgery, and have been seen by an ophthalmologist at least once with complaint of continued ocular pain since surgery
  • Subjects with moderate to severe ocular pain (VAS ≥ 50 mm) at Screening Visit.

Exclusion Criteria

  • Use of contact lenses within 14 days of the screening visit or for duration of the study
  • Use of artificial tears, gels, lubricants or pain medication within 4 hours of conducting assessments at the Screening Visit
  • Use of nerve growth factor eye drops within 14 days of the Screening Visit.

Study Requirements

Study participation is 6 months, with 6 study visits. You will be asked to come to clinic 6 times for a full eye exam, including ocular imaging. You will also be asked to use your randomily assigned study drug (Dose 1, Dose 2 or Placebo) twice a day- morning and night.