A study to evaluate SAF312 eye drops in the treatment of post-operative corneal induced chronic pain (CICP) (H-49449)

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 (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) or cataract or other refractive surgeries

Many patients suffer from acute ocular pain (eye pain that lasts a few days) due to different problems, however there is no available treatment for chronic eye pain (long lasting eye pain). Very often eye pain is reported after surgical procedures, like Photorefractive Keratectomy (PRK), Laser-assisted in situ Keratomileusis (LASIK), Laser Assisted Sub-Epithelial Keratectomy (LASEK), Radial Keratotomy (RK), Small Incision Lenticule Extraction (SMILE) and cataract surgery (including clear lensectomy). Many patients have pain that goes away within one month after surgery. However, up to 60% of patients continue to have chronic pain beyond one month, which may continue up to 6 months; and in some cases, the pain will continue for many years or even permanently. It is also known that many patients with chronic pain do not necessarily describe their symptoms as “pain”, and that the description can change from day-to-day or even within a day. Sometimes patients may experience pain with other symptoms like burning, stinging, foreign body sensation, stabbing, pressure, grittiness or sandiness. Therefore, the term “pain” is used as an umbrella term, which can include any description of what the patient considers painful. 

There is currently no treatment for this condition. SAF312 is currently under development as topical ocular eye drops and is being evaluated for the treatment of corneal induced chronic pain (CICP). This study treatment is not currently approved by the United States Food and Drug Administration (FDA).

The purpose of the study is to demonstrate that SAF312 is effective and safe for treatment of this type of chronic pain. The study will also determine which of two strengths of the medicine (0.5% or 1.5%) has the better effect and safety profile.