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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-21

Study Completion Date

2023-06-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of SAF312 as an Eye Drop for Treatment of Eye Pain Following Photorefractive Keratectomy (PRK) Surgery

NCT02961062

Postoperative Ocular Pain After PRK Surgery

COMPLETED PHASE2

Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain

NCT02793817

Post Surgical Ocular Inflammation and Pain

COMPLETED PHASE3

Study to See How Well an Eye Drop, SURF-201, Works and What Side Effects There Are in Cataract Surgery Subjects

NCT04324359

Post-surgical Ocular Inflammation Post-surgical Ocular Pain

COMPLETED PHASE2

A Phase 3 Study Evaluating the Efficacy and Safety of OCS-01 Eyedrops Compared to Vehicle for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

NCT05147233

Inflammation Eye Pain Postoperative Cataract

COMPLETED PHASE3

Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery

NCT04739709

Ocular Inflammation and Pain

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This was a Phase II randomized, double-masked, multi-center, parallel group, placebo-controlled study to evaluate the safety and efficacy of SAF312, 5 mg/mL and 15 mg/mL eye drops versus Placebo used twice-daily in both eyes for 12 weeks. The study consisted of a 12-week observation period starting from Screening Visit (Visit 1) until the Baseline/Randomization Visit (Visit 2). Subjects who met eligibility criteria at Visit 2 were randomized to one of the three treatment arms (SAF312 5 mg/mL, SAF312 15 mg/mL, Placebo) in a 1:1:1 ratio. Subjects who qualified for randomization had visits every 2 weeks for the first 4 weeks, and then monthly visits for the remainder of the 12-week treatment period.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Ocular Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-blinded

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SAF312 Placebo

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

Group Type PLACEBO_COMPARATOR