Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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 or cataract 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
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
Key Inclusion Criteria:
- Subjects who have undergone refractive surgery (i.e., PRK, LASIK, LASEK, RK, or SMILE)
in both eyes or cataract surgery in both eyes, with or without refractive enhancement
in one or both eyes, ≥4 months prior to Screening Visit and experiencing persistent
ocular surface pain since the surgery, and have been seen by an ophthalmologist or
optometrist 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 an average pain severity VAS score of ≥ 30 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 requiring hospitalization within 6 months prior to screening for severe
psychiatric disorders (e.g. psychosis, schizophrenia, mania, depression) or major
psychiatric illness.