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

NCT04630158 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CSAF312B122012021-005857-97
• Study Type: interventional
• Target: 153
• Locations: 3 countries
• Sites: 28

Brief Summary

The study was designed to demonstrate the safety and efficacy of two dose concentrations of SAF312 eye drops (5 mg/mL and 15 mg/mL) in subjects with CICP persisting at least for 4 months after refractive or cataract surgery and chronicity confirmed during the observational period. The study also determined the optimal dose to carry forward for further development.

Conditions

Chronic Ocular Pain

Keywords

Eye pain; Dry eye like symptoms; Ocular surface pain; Corneal induced chronic pain; neuropathic eye pain; post-operative corneal induced chronic pain; CICP; corneal; corneal pain

Outcome Measures

Primary Outcomes (1)

• Change From Baseline at Week 12 in Ocular Pain Severity Visual Analog Scale (VAS)

  The pain severity Visual Analogue Scale (VAS) was completed by the subject using an electronic diary. A vertical mark was placed on the horizontal scoring line (anchored with 'No Pain' on the left and 'Very Severe' pain on the right) to score the severity of ocular pain over the past 24 hours, with a range from 0 (min) to 100 (max). Higher scores indicate higher pain severity. A negative change from baseline is a positive outcome.

  Baseline, Week 12

Secondary Outcomes (16)

• Ocular Pain Severity Visual Analog Scale (VAS): Summary Statistics of Change From Baseline at Day 7 and Day 14

  Baseline, Days 7 and 14

• Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12

  Baseline, Weeks 1 to 12

• Ocular Pain Assessment Scale (OPAS) Subscale Quality of Life: Summary Statistics of Change From Baseline to Week 12

  Baseline, Weeks 2, 4, 8, 12

• Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Dexter (OD) = Right Eye)

  Baseline, Weeks 2, 4, 8, 12

• Ocular Surface Parameters: Summary Statistics of Change From Baseline by Week - Conjunctival Redness - Nasal (Oculus Sinister (OS) = Left Eye)

  Baseline, Weeks 2, 4, 8, 12

Study Arms (3)

SAF312 Placebo

PLACEBO COMPARATOR

Randomized to a 1:1:1 topical eye drops, twice daily

Other: SAF312 Placebo

SAF312 5 mg/mL

EXPERIMENTAL

Randomized to a 1:1:1 topical eye drops, twice daily

Drug: SAF312

SAF312 15 mg/mL

EXPERIMENTAL

Randomized to a 1:1:1 topical eye drops, twice daily

Drug: SAF312

Interventions

SAF312 Placebo OTHER

Topical ocular, suspension eye drops

Also known as: Artificial tears

SAF312 Placebo

SAF312 DRUG

Topical ocular, suspension eye drops

SAF312 15 mg/mL; SAF312 5 mg/mL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (28)

North Valley Eye Medical Group

Mission Hills, California, 91345, United States

Location

NVISION Eye Centers

Newport Beach, California, 92660, United States

Location

Stanford Eye Laser Center

Palo Alto, California, 94303, United States

Location

Gordon Schanzlin New Vision Inst

San Diego, California, 92122, United States

Location

Novartis Investigative Site

Coral Springs, Florida, 33067, United States

Location

Novartis Investigative Site

Jacksonville, Florida, 32256, United States

Location

Novartis Investigative Site

Miami, Florida, 33136, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Boston Sight

Needham, Massachusetts, 02494, United States

Location

Univ of MI Kellogg Eye Center .

Ann Arbor, Michigan, 48105, United States

Location

Duke Univ Medical Center Ophthalmology

Durham, North Carolina, 27710, United States

Location

Bergstrom Eye Research LLC

Fargo, North Dakota, 58103, United States

Location

University of Pennsylvania .

Philadelphia, Pennsylvania, 19104, United States

Location

Chattanooga Eye Institute

Chattanooga, Tennessee, 37411, United States

Location

Novartis Investigative Site

Memphis, Tennessee, 38119, United States

Location

Advancing Vision Research LLC

Smyrna, Tennessee, 37167, United States

Location

Novartis Investigative Site

Houston, Texas, 77025, United States

Location

Novartis Investigative Site

Houston, Texas, 77030, United States

Location

Novartis Investigative Site

Houston, Texas, 77074, United States

Location

Lake Travis Eye and Laser Ctr

Lakeway, Texas, 78738, United States

Location

Stacy R Smith MD PC

Salt Lake City, Utah, 84117, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 24502, United States

Location

Rainier Clinical Research Center Inc .

Renton, Washington, 98057, United States

Location

Periman Eye Institute

Seattle, Washington, 98119, United States

Location

Novartis Investigative Site

Sapporo, Hokkaido, 060 8648, Japan

Location

Novartis Investigative Site

Shinagawa, Tokyo, 141-0022, Japan

Location

Novartis Investigative Site

Birmingham, West Midlands, B75 6QW, United Kingdom

Location

Novartis Investigative Site

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Related Publications (1)

• Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.

  PMID: 36729473 DERIVED

Related Links

• A Plain Language Trial Summary is available on www.novctrd.com

MeSH Terms

Conditions

Eye Pain

Interventions

Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Eye Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@Novartis.com

+ 1 862 778 8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 16, 2020
• Study Start: April 21, 2021
• Primary Completion: June 7, 2023
• Study Completion: June 8, 2023
• Last Updated: October 9, 2024
• Results First Posted: April 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

GB (2); JP (2); US (24)