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Study of Efficacy and Safety of SAF312 Eye Drops in Subjects With Post-operative Corneal Induced Chronic Pain (CICP)
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).
Summary
This trial is testing SAF312 eye drops, available in two strengths, on patients who have had long-lasting eye pain after eye surgery. The goal is to see if these drops can safely reduce their pain and swelling.
Eligible Conditions
- Chronic Ocular Pain
Timeline
Screening ~ 3 weeks3 visits
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).
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).
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change From Baseline at Week 12 in Ocular Pain Severity Visual Analog Scale (VAS)
Secondary study objectives
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 moreSide effects data
From 2023 Phase 2 trial • 153 Patients • NCT046301584%
COVID-19
3%
Eye discharge
3%
Eye pain
3%
Dry eye
2%
Eye pruritus
2%
Ocular hyperaemia
2%
Erythema of eyelid
2%
Eye irritation
2%
Vision blurred
2%
Sinusitis
1%
Rhinorrhoea
1%
Nausea
1%
Dermatitis contact
1%
Instillation site pruritus
1%
Medical device site irritation
1%
Oropharyngeal pain
1%
Hypertension
1%
Non-cardiac chest pain
1%
Hordeolum
1%
Skin laceration
1%
Corneal abrasion
1%
Herpes virus infection
1%
Therapy responder
1%
Laryngitis
1%
Back pain
1%
Optic nerve cupping
1%
Swelling of eyelid
1%
Upper respiratory tract infection
1%
Instillation site irritation
1%
Lacrimation increased
1%
Buttock injury
1%
Osteoarthritis
1%
Urinary tract infection
1%
Diabetic bullosis
1%
Joint injury
1%
Vomiting
1%
Exostosis
1%
Arthralgia
1%
Herpes zoster
1%
Vitreous detachment
1%
Ear infection
1%
Nasopharyngitis
1%
Pharyngitis streptococcal
1%
Fall
1%
Foreign body in eye
1%
Sarcoma
1%
Dizziness
1%
Headache
1%
Pruritus
1%
Rash
1%
Spinal compression fracture
1%
Blepharitis
1%
Chalazion
1%
Conjunctival papillae
1%
Corneal oedema
1%
Dry age-related macular degeneration
1%
Drug hypersensitivity
1%
Hot flush
100%
80%
60%
40%
20%
0%
Study treatment Arm
Total
SAF312 15 mg/mL
SAF312 5 mg/mL
SAF312 Placebo
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
2,920 Previous Clinical Trials
4,254,149 Total Patients Enrolled