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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 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%
Dry eye
4%
COVID-19
4%
Eye pruritus
4%
Hordeolum
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%
Ear infection
2%
Herpes virus infection
2%
Laryngitis
2%
Arthralgia
2%
Dizziness
2%
Headache
2%
Diabetic bullosis
2%
Urinary tract infection
2%
Vision blurred
2%
Rhinorrhoea
2%
Hypertension
2%
Vomiting
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

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Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,866 Previous Clinical Trials
4,199,173 Total Patients Enrolled
~37 spots leftby Jun 2025
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