Study of Efficacy and Safety of SAF312 Eye Drops in Subjects With Post-operative Corneal Induced Chronic Pain (CICP)

• Status: Recruiting
• Trial end date: 2022-12-05
• Target enrollment: 0
• Participant gender: All

Summary

The study is designed to demonstrate the safety and efficacy of two dose concentrations of SAF312 eye drops (dose 1 and dose 2) in subjects with 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Lubricant Eye Drops

Criteria

Key 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 who demonstrate a ≥ 60% reduction in ocular pain within 5 minutes after instillation of a single topical ocular anesthetic drop at Screening Visit.

At Baseline

• Subjects with moderate to severe ocular pain defined as an average pain severity VAS score of ≥ 50 mm based on Daily eDiary for the last 7 days prior to Baseline Visit.

• Subjects who have reported pain severity >10 mm based on Daily eDiary for > 50% of the days of the observational period (Screening)

Key Exclusion Criteria:

• Use of nerve growth factor eye drops within 14 days of the Screening Visit

• Seasonal allergic conjunctivitis, or other acute or seasonal ocular diagnosis that are active at the time of Screening or would be active during the course of the study.

• Any history of ocular herpes simplex virus or herpes zoster virus infection, or other severe ocular conditions such as graft versus host disease, Stevens-Johnson syndrome or sarcoidosis.

• Presence of any ocular infection (bacterial, viral, or fungal) within 30 days prior to Screening.

• Chronic topical ocular medications (ie. cyclosporine, lifitegrast) initiated <6 months prior to Screening Visit, or any anticipated change during the study.

• Use of ocular or nasal corticosteroids within 30 days of Screening Visit.

• Use of neuromodulatory medications (eg, gabapentin, pregabalin) or opioid use for non-ocular pain within 30 days of Screening Visit.

• Chronic medications (both over the counter and prescription) that have not been stable for at least 30 days prior to Screening Visit, or any anticipated change in the chronic medication regimen.

• Subjects with severe psychiatric disorders (e.g. psychosis, schizophrenia, mania, depression) or major psychiatric illness requiring recent hospitalization (ie, in the last 6 months) or requiring treatment with more than one psychiatric medication (ie, anti-depressants, anti-psychotics, anxiolytics).