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

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) Surgeries

ClinicalTrials.gov Identifier: NCT04630158

Novartis Reference Number: CSAF312B12201

Last Update: May 10, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Chronic Ocular Pain
Phase 
Phase 2
Overall status 
Recruiting
Start date 
Apr 21, 2021
Completion date 
Apr 24, 2023
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Other
SAF312 Placebo
Topical ocular, suspension eye drops,
Drug
SAF312
Topical ocular, suspension eye drops

Eligibility Criteria

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.

Study Locations

United States
Novartis Investigative Site
Recruiting
Mission Hills, 91345
California
United States
Novartis Investigative Site
Recruiting
Newport Beach, 92660
California
United States
Novartis Investigative Site
Recruiting
Palo Alto, 94303
California
United States
Novartis Investigative Site
Recruiting
San Diego, 92122
California
United States
Novartis Investigative Site
Recruiting
Coral Springs, 33067
Florida
United States
Novartis Investigative Site
Recruiting
Fort Lauderdale, 33309
Florida
United States
Novartis Investigative Site
Recruiting
Jacksonville, 32256
Florida
United States
Novartis Investigative Site
Recruiting
Miami, 33136
Florida
United States
Novartis Investigative Site
Recruiting
Atlanta, 30328
Georgia
United States
Novartis Investigative Site
Recruiting
Atlanta, 30339
Georgia
United States
Novartis Investigative Site
Recruiting
Baltimore, 21201
Maryland
United States
Novartis Investigative Site
Recruiting
Boston, 02111
Massachusetts
United States
Novartis Investigative Site
Recruiting
Needham, 02494
Massachusetts
United States
Novartis Investigative Site
Recruiting
Ann Arbor, 48105
Michigan
United States
Novartis Investigative Site
Recruiting
Kansas City, 64155
Missouri
United States
Novartis Investigative Site
Recruiting
Las Vegas, 98102
Nevada
United States
Novartis Investigative Site
Recruiting
Durham, 27710
North Carolina
United States
Novartis Investigative Site
Recruiting
Fargo, 58103
North Dakota
United States
Novartis Investigative Site
Recruiting
Oklahoma City, 73104
Oklahoma
United States
Novartis Investigative Site
Recruiting
Philadelphia, 19104
Pennsylvania
United States
Novartis Investigative Site
Recruiting
Chattanooga, 37411
Tennessee
United States
Novartis Investigative Site
Recruiting
Maryville, 37803
Tennessee
United States
Novartis Investigative Site
Recruiting
Memphis, 38119
Tennessee
United States
Novartis Investigative Site
Recruiting
Nashville, 37215
Tennessee
United States
Novartis Investigative Site
Recruiting
Smyrna, 37167
Tennessee
United States
Novartis Investigative Site
Recruiting
Bellaire, 77401
Texas
United States
Novartis Investigative Site
Recruiting
Houston, 77025
Texas
United States
Novartis Investigative Site
Recruiting
Houston, 77030
Texas
United States
Novartis Investigative Site
Recruiting
Lakeway, 78738
Texas
United States
Novartis Investigative Site
Recruiting
San Antonio, 78240
Texas
United States
Novartis Investigative Site
Recruiting
Salt Lake City, 84117
Utah
United States
Novartis Investigative Site
Recruiting
Lynchburg, 24502
Virginia
United States
Novartis Investigative Site
Recruiting
Renton, 98057
Washington
United States
Novartis Investigative Site
Recruiting
Seattle, 98119
Washington
United States

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

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