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Growth Factor

Oxervate for Dry Eye Syndrome (NGF0121 Trial)

Phase 3
Waitlist Available
Research Sponsored by Dompé Farmaceutici S.p.A
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 week 4, 8, 12 and 16
Awards & highlights

Summary

This trial tests cenegermin eye drops in patients with severe Sjogren's dry eye disease. Cenegermin helps heal the eye's surface, potentially improving dry eye symptoms. The study compares its effectiveness to another treatment over a period of time. Cenegermin is a recombinant human nerve growth factor that has been found to be safe and well tolerated.

Eligible Conditions
  • Dry Eye Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4, 8, 12 and 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4, 8, 12 and 16 for reporting.

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 in Symptoms Questionnaire (SANDE) Global Score at Week 12
Number of Patients Reaching a Value of Schirmer I Test (Without Anaesthesia) >10mm/5min at Week 4
Secondary study objectives
Change From Baseline in "Symptom Bother Module" Measured by "Impact of Dry Eye on Everyday Life [IDEEL]" Questionnaire at Week 8 and Week 16
Change From Baseline in "Treatment Satisfaction & Bother" Module Measured by "Impact of Dry Eye on Everyday Life [IDEEL]" Questionnaire at Week 8 and Week 16
Change From Baseline in Cornea and Conjunctiva Vital Staining With Fluorescein (National Eye Institute [NEI] Scales) at Week 16
+15 more
Other study objectives
Incidence and Frequency of TEAEs, Assessed Throughout the Study.

Side effects data

From 2022 Phase 3 trial • 104 Patients • NCT05133180
31%
Eye pain - Mild
13%
Eye pain - Moderate
12%
Eyelid pain - Mild
10%
Eyelid pain - Moderate
6%
Eye pain - Severe
4%
Eye discharge - Mild
4%
Foreign body sensation in eyes - Moderate
4%
Dry eye - Mild
4%
Dry eye - Moderate
4%
Photophobia - Severe
4%
Vision blurred - Moderate
4%
Vision blurred - Mild
2%
Pancreatitis acute - Moderate
2%
Fatigue - Severe
2%
Visual acuity reduced - Moderate
2%
Hypertransaminasaemia - Moderate
2%
Lacrimation increased - Mild
2%
Pancreatitis acute
2%
Asthenopia - Mild
2%
Chalazion - Mild
2%
Chalazion - Moderate
2%
Conjunctival hyperaemia - Mild
2%
Corneal oedema - Moderate
2%
Visual acuity reduced
2%
Bacteraemia
2%
Eye irritation - Mild
2%
Hypertransaminasaemia
2%
Eyelid disorder - Mild
2%
Eye irritation - Moderate
2%
Eye pruritus - Mild
2%
Eyelid sensory disorder - Mild
2%
Periorbital pain - Mild
2%
Photophobia - Mild
2%
Swelling of eyelid - Moderate
2%
Ulcerative keratitis - Mild
2%
Keratopathy - Moderate
2%
Ocular hyperaemia - Mild
2%
Periorbital pain - Moderate
2%
Eyelid pain - Severe
2%
Eyelid ptosis - Moderate
2%
Photophobia - Moderate
2%
Visual field defect - Mild
2%
Punctate keratitis - Moderate
2%
Visual impairment - Moderate
2%
Instillation site pain - Mild
2%
Bile duct stone - Moderate
2%
Bacteraemia - Moderate
2%
COVID-19 - Mild
2%
COVID-19 - Moderate
2%
Genital herpes simplex -Mild
2%
Migraine - Mild
2%
Upper respiratory tract infection - Mild
2%
Urinary tract infection - Mild
2%
Arthropod bite - Mild
2%
Meniscus injury - Moderate
2%
Spinal compression fracture - Mild
2%
Blood thyroid stimulating hormone increased - Mild
2%
Fibromyalgia - Moderate
2%
Rheumatoid arthritis - Mild
2%
Scleroderma - Moderate
2%
Systemic lupus erythematosus - Moderate
2%
Aura - Mild
2%
Headache - Mild
2%
Headache - Moderate
2%
Headache - Severe
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oxervate (SAF)
Vehicle (SAF)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OxervateExperimental Treatment1 Intervention
One drop of cenegermin 20 mcg/mL (rhNGF 20 mcg/mL) in the pharmaceutical form of ophthalmic sterile solution was instilled in both eyes three times daily (TID), every six hours.
Group II: VehiclePlacebo Group1 Intervention
One drop of vehicle ophthalmic solution was instilled in both eyes TID (every six hours).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxervate
2022
Completed Phase 3
~190

Find a Location

Who is running the clinical trial?

Dompé Farmaceutici S.p.ALead Sponsor
51 Previous Clinical Trials
4,604 Total Patients Enrolled
Francesco Sergio, MDStudy DirectorDompé Farmaceutici
2 Previous Clinical Trials
412 Total Patients Enrolled
Flavio Mantelli, MDStudy DirectorDompé Farmaceutici
2 Previous Clinical Trials
286 Total Patients Enrolled
~28 spots leftby Sep 2025
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