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Growth Factor
Oxervate for Dry Eye Syndrome (NGF0221 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 from screening day ( day 8) up to follow-up week 24 (day 168 +/-7days)
Awards & highlights
Pivotal Trial
Summary
This trial tests cenegermin eye drops in patients with severe Sjogren's dry eye disease. These patients are already using another treatment but need more help. The eye drops work by promoting healing and repair of the eye's surface.
Eligible Conditions
- Dry Eye Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from screening day ( day 8) up to follow-up week 24 (day 168 +/-7days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening day ( day 8) up to follow-up week 24 (day 168 +/-7days)
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 SANDE global score
Schirmer I test (without anesthesia) >10mm/5min in the eligible eye
Secondary study objectives
Conjunctiva
Change from baseline in SANDE scores for severity and frequency
Change from baseline in Schirmer I test (without anesthesia)
+4 moreSide effects data
From 2022 Phase 3 trial • 104 Patients • NCT0513318031%
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%
Fatigue - Severe
2%
Visual acuity reduced - Moderate
2%
Hypertransaminasaemia - Moderate
2%
Pancreatitis acute - 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)
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: OxervateExperimental Treatment1 Intervention
Oxervate®, an ophthalmic solution containing cenegermin 20 mcg/mL, which is a recombinant human Nerve Growth Factor (rhNGF). in this arm one drop of cenegermin 20 mcg/mL will be instilled in both eyes TID for 28 consecutive days.
Group II: VehiclePlacebo Group1 Intervention
In this arm one drop of vehicle will be instilled in both eyes TID for 28 consecutive days.
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
4,306 Total Patients Enrolled
Francesco Sergio, MDStudy DirectorDompé Farmaceutici
2 Previous Clinical Trials
244 Total Patients Enrolled
Yureeda Qazi, MDStudy DirectorDompé Farmaceutici
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with Sjogren syndrome or another autoimmune disease that can cause dry eye disease.You have struggled with drug addiction or excessive alcohol use in the past year.You have severe Sjogren's dry eye disease, as determined by a questionnaire that measures your dry eye symptoms.You have had cancer in the past 5 years.You have a history of serious allergies that affect your whole body or allergies specifically related to your eyes, except for dry eye.
Research Study Groups:
This trial has the following groups:- Group 1: Oxervate
- Group 2: Vehicle
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Dry Eye Syndrome Patient Testimony for trial: Trial Name: NCT05136170 — Phase 3
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