Study of efficacy and safety of SAF312 eye drops in subjects with post-operative corneal induced chronic pain (CICP)

JRCT ID: jRCT2011220008

Registered date:29/05/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: corneal induced chronic pain
• Date of first enrollment: 28/07/2022
• Target sample size: 15
• Countries of recruitment: United States,Japan,United Kingdom,Japan
• Study type: Interventional

Intervention(s)

all eligible subjects will be randomized to one of the treatment arms in the double-blinded treatment.
- SAF312 Placebo eye drops, twice daily
- SAF312 dose1 eye drops, twice daily
- SAF312 dose2 eye drops, twice daily

Outcome(s)

• Primary Outcome: Change from baseline to Week 12 in weekly mean pain severity Visual Analog Scale (VAS)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Subjects who have undergone refractive surgery (i.e., PRK, LASIK, LASEK, RK, or SMILE) 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).

Exclude 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 (i.e., 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 (e.g., 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 or major psychiatric illness (e.g., psychosis, schizophrenia, mania, depression).

Related Information

• Primary Sponsor: Yamada Hiroyuki
• Secondary ID(s): NCT04630158