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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

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 4, 8, 12 and 16

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

Eye pain - Severe

Eye discharge - Mild

Foreign body sensation in eyes - Moderate

Dry eye - Mild

Dry eye - Moderate

Photophobia - Severe

Vision blurred - Moderate

Vision blurred - Mild

Fatigue - Severe

Visual acuity reduced - Moderate

Hypertransaminasaemia - Moderate

Pancreatitis acute - Moderate

Lacrimation increased - Mild

Pancreatitis acute

Asthenopia - Mild

Chalazion - Mild

Chalazion - Moderate

Conjunctival hyperaemia - Mild

Corneal oedema - Moderate

Visual acuity reduced

Bacteraemia

Eye irritation - Mild

Hypertransaminasaemia

Eyelid disorder - Mild

Eye irritation - Moderate

Eye pruritus - Mild

Eyelid sensory disorder - Mild

Periorbital pain - Mild

Photophobia - Mild

Swelling of eyelid - Moderate

Ulcerative keratitis - Mild

Keratopathy - Moderate

Ocular hyperaemia - Mild

Periorbital pain - Moderate

Eyelid pain - Severe

Eyelid ptosis - Moderate

Photophobia - Moderate

Visual field defect - Mild

Punctate keratitis - Moderate

Visual impairment - Moderate

Instillation site pain - Mild

Bile duct stone - Moderate

Bacteraemia - Moderate

COVID-19 - Mild

COVID-19 - Moderate

Genital herpes simplex -Mild

Migraine - Mild

Upper respiratory tract infection - Mild

Urinary tract infection - Mild

Arthropod bite - Mild

Meniscus injury - Moderate

Spinal compression fracture - Mild

Blood thyroid stimulating hormone increased - Mild

Fibromyalgia - Moderate

Rheumatoid arthritis - Mild

Scleroderma - Moderate

Systemic lupus erythematosus - Moderate

Aura - Mild

Headache - Mild

Headache - Moderate

Headache - Severe

100%

80%

60%

40%

20%

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

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

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