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SAF312 for Chronic Ocular Pain

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 7 and day 14
Awards & highlights

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 Ocular Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 7 and day 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 7 and day 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in mean pain severity Visual Analog Scale
Secondary outcome measures
Change in Ocular Pain Assessment Scale (OPAS) sub-scale Quality of Life
Change in ocular surface parameters as assessed by Schirmer's testing
Change in ocular surface parameters as assessed by lissamine staining
+5 more

Side effects data

From 2018 Phase 2 trial • 40 Patients • NCT02961062
5%
Nasopharyngitis
3%
Arthralgia
3%
Sinus congestion
3%
Sinusitis
3%
Oropharyngeal pain
3%
Headache
3%
Corneal opacity
3%
Punctate keratitis
3%
Vitreous detachment
3%
Vomiting
3%
Pyrexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
SAF312
Vehicle

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: SAF312 dose 2Experimental Treatment1 Intervention
Randomized to a 1:1:1 topical eye drops, twice daily
Group II: SAF312 dose 1Experimental Treatment1 Intervention
Randomized to a 1:1:1 topical eye drops, twice daily
Group III: SAF312 PlaceboPlacebo Group1 Intervention
Randomized to a 1:1:1 topical eye drops, twice daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SAF312
2016
Completed Phase 2
~200

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,200 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has SAF312 been granted approval by the US Food and Drug Administration?

"Due to the lack of efficacy data and presence of safety data, our team assigned SAF312 a score of 2 on a scale from 1-3."

Answered by AI

To what extent is enrollment being offered for this clinical trial?

"Affirmative. Clinicaltrials.gov attests that this scientific trial is currently recruiting participants, the initial post being on April 21st 2021 and last revised November 3rd 2022. 150 volunteers are needed from 31 distinct locations to participate in this study."

Answered by AI

Is enrollment in this trial still available?

"The data on clinicaltrials.gov affirms that this trial is actively enrolling participants, with the initial posting being made April 21st 2021 and most recent edits occurring November 3rd 2022."

Answered by AI

In what count of medical centers is this research experiment being conducted?

"Currently, 31 medical facilities in cities such as Bellaire, Smyrna and Oklahoma City are running this trial. It is recommended that prospective participants choose the clinic closest to them to avoid extensive travel needs if they decide to enroll."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Study of Efficacy and Safety of SAF312 Eye Drops in Subjects With Post-operative Corneal Induced Chronic Pain (CICP)
2021. "Study of Efficacy and Safety of SAF312 Eye Drops in Subjects With Post-operative Corneal Induced Chronic Pain (CICP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04630158.
~38 spots leftby Apr 2025
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