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

NCT04630158 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2024-10-09

Study results available
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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

Interventions

OTHER

SAF312 Placebo

Topical ocular, suspension eye drops

DRUG

SAF312

Topical ocular, suspension eye drops

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-21
Primary Completion
2023-06-07
Completion
2023-06-08
FDA Drug
Yes

Countries

  • United States
  • Japan
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04630158 on ClinicalTrials.gov