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Growth Factor
Study to Evaluate Safety and Efficacy of Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease (PROTEGO-2 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 at week 2 (visit 2), week 4 (visit 3), week 8 (visit 4), week 12 (visit 5), and week 16 (visit 6)
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 ~ at week 2 (visit 2), week 4 (visit 3), week 8 (visit 4), week 12 (visit 5), and week 16 (visit 6)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 2 (visit 2), week 4 (visit 3), week 8 (visit 4), week 12 (visit 5), and week 16 (visit 6)
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 Symptom Questionnaire (SANDE) Global Score at Week 12
Number of Patients With Schirmer I Test (Without Anesthesia) >10mm/5min in the Eligible Eye at Week 4
Secondary study objectives
Change From Baseline in "Quality of Life, Dry Eye Treatment Satisfaction & Bother and Dry Eye Symptom-Bother" Modules Measured by "Impact of Dry Eye on Everyday Life [IDEEL]" Questionnaire at Week 4, Week, 8, Week 12, and Week 16
Change From Baseline in Cornea and Conjunctiva Vital Staining With Fluorescein (National Eye Institute [NEI] Scales) at Week 4, Week 8, Week 12 and Week 16
Change From Baseline in Schirmer I Test (Without Anaesthesia) at Week 4, Week 8, Week 12, and Week 16
+8 moreOther study objectives
Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA)
Change From Baseline in Cornea and Conjunctiva Vital Staining With Fluorescein (National Eye Institute [NEI] Scales) at Week 2
Change From Baseline in Schirmer I Test (Without Anaesthesia) at Week 2
+6 moreSide effects data
From 2023 Phase 3 trial • 85 Patients • NCT0513617010%
Eye pain
10%
Headache
8%
Dry eye
5%
Foreign body sensation in eyes
5%
Eye discharge
5%
Vision blurred
3%
Swelling of eyelid
3%
Conjunctival hyperaemia
3%
Eye irritation
3%
SARS-CoV-2 test positive
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vehicle - SAF
Cenegermin - 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: CenegerminExperimental 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
In this arm one drop of vehicle was instilled in both eyes TID for 28 consecutive days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cenegermin
2022
Completed Phase 3
~90
Find a Location
Who is running the clinical trial?
Dompé Farmaceutici S.p.ALead Sponsor
52 Previous Clinical Trials
4,343 Total Patients Enrolled
Flavio Mantelli, MDStudy DirectorDompé Farmaceutici
3 Previous Clinical Trials
390 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: Cenegermin
- 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