← Back to Search

Other

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 adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of 119 days (approximately 4 months).
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 ~adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of 119 days (approximately 4 months).
This trial's timeline: 3 weeks for screening, Varies for treatment, and adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of 119 days (approximately 4 months). 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 From Baseline at Week 12 in Ocular Pain Severity Visual Analog Scale (VAS)
Secondary outcome measures
Number of Participants With Treatment Emergent Adverse Events
Ocular Pain Assessment Scale (OPAS) Subscale Quality of Life: Summary Statistics of Change From Baseline to Week 12
Ocular Pain Frequency Visual Analog Scale (VAS): Summary Statistics of Weekly Mean Change From Baseline to Week 12
+13 more

Side effects data

From 2023 Phase 2 trial • 153 Patients • NCT04630158
6%
Eye pain
6%
Sinusitis
4%
Hordeolum
4%
Dry eye
4%
COVID-19
4%
Eye pruritus
2%
Hypertension
2%
Vitreous detachment
2%
Non-cardiac chest pain
2%
Upper respiratory tract infection
2%
Herpes zoster
2%
Dry age-related macular degeneration
2%
Eye discharge
2%
Eye irritation
2%
Nausea
2%
Vomiting
2%
Ear infection
2%
Herpes virus infection
2%
Laryngitis
2%
Urinary tract infection
2%
Arthralgia
2%
Dizziness
2%
Headache
2%
Rhinorrhoea
2%
Diabetic bullosis
2%
Vision blurred
100%
80%
60%
40%
20%
0%
Study treatment Arm
SAF312 15 mg/mL
Total
SAF312 Placebo
SAF312 5 mg/mL

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: SAF312 5 mg/mLExperimental Treatment1 Intervention
Randomized to a 1:1:1 topical eye drops, twice daily
Group II: SAF312 15 mg/mLExperimental 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
2,863 Previous Clinical Trials
4,199,182 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 May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top