SAF312 for Chronic Pain

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Chronic Pain+1 More
SAF312 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is designed to study the safety and effectiveness of two concentrations of an eye drop medication in people who still have corneal problems four months after surgery. The goal is to also find the optimal dose of the medication to continue development.

Eligible Conditions
  • Chronic Pain
  • Chronic Ocular Pain

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Baseline, Day 7 and Day 14

84 days
Change in mean pain severity Visual Analog Scale
Day 14
Change in pain severity Visual Analog Scale
Day 88
Comparison of adverse events rates between active and placebo
Baseline, Week 12
Change in Ocular Pain Assessment Scale (OPAS) sub-scale Quality of Life
Change in ocular surface parameters (eg, corneal and conjunctival staining score, Schirmer score, conjunctival redness score)
Change in ocular surface parameters as assessed by Schirmer's testing
Change in ocular surface parameters as assessed by lissamine staining
Change in ocular surface parameters as assessed by the corneal fluorescein staining
Change in ocular surface parameters as evaluated by the investigator using the McMonnies redness photographic scale.
Change in pain frequency Visual Analog Scale

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Vehicle
3%Tinnitus
3%Headache
3%Corneal infiltrates
3%Punctate keratitis
3%Corneal opacity
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT02961062) in the Vehicle ARM group. Side effects include: Tinnitus with 3%, Headache with 3%, Corneal infiltrates with 3%, Punctate keratitis with 3%, Corneal opacity with 3%.

Trial Design

3 Treatment Groups

SAF312 dose 2
1 of 3
SAF312 dose 1
1 of 3
SAF312 Placebo
1 of 3
Experimental Treatment
Non-Treatment Group

150 Total Participants · 3 Treatment Groups

Primary Treatment: SAF312 · Has Placebo Group · Phase 2

SAF312 dose 2
Drug
Experimental Group · 1 Intervention: SAF312 · Intervention Types: Drug
SAF312 dose 1
Drug
Experimental Group · 1 Intervention: SAF312 · Intervention Types: Drug
SAF312 Placebo
Other
PlaceboComparator Group · 1 Intervention: SAF312 Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SAF312
2016
Completed Phase 2
~40

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, day 7 and day 14

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,692 Previous Clinical Trials
3,522,810 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
This text is discussing people who have reported pain severity that is higher than 10mm on a scale of 0-10 based on a diary they have been keeping for over 50% of the days during the observational period.
Subjects who demonstrate a significant reduction in ocular pain within 5 minutes after instillation of a single topical ocular anesthetic drop at Screening Visit.
People who have had refractive surgery or cataract surgery in both eyes, and are still experiencing pain, are asked to participate in this study.
Subjects with a pain severity score of 30 or more on a scale of 0 to 100 based on a diary of pain symptoms for the last seven days prior to the study's start.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 31st, 2021

Last Reviewed: October 16th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Tennessee100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%