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

  • STATUS
    Recruiting
  • End date
    Dec 5, 2022
  • participants needed
    150
  • sponsor
    Novartis Pharmaceuticals
Updated on 28 November 2021

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.

Description

This study is a Phase 2 randomized, double-blinded, multi-center, parallel group, placebo-controlled evaluation of the safety and efficacy of SAF312 dose 1 and dose 2 eye drops versus placebo used twice-daily in both eyes for 12 weeks. Eligible subjects will have undergone refractive surgery (PRK or LASIK) in both eyes at least 4 months prior to Screening, and have been suffering from chronic ocular pain as a result of the their surgery. Eligible patients must also demonstrate chronicity of the pain at Baseline Visit as described in inclusion criteria. Overall approximately 150 subjects will be enrolled in the study and randomized to one of 3 study arms in 1:1:1 ratio

Details
Condition Chronic Ocular Pain
Treatment SAF312, SAF312 Placebo
Clinical Study IdentifierNCT04630158
SponsorNovartis Pharmaceuticals
Last Modified on28 November 2021

Eligibility

Yes No Not Sure

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)

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)
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