Safety and Efficacy Study on Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease (PROTEGO-1 Study) (NGF0121 Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Dompé Farmaceutici S.p.A
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
Treatment Details
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).
Find a clinic near you
Research locations nearbySelect from list below to view details:
Houston Eye Associates HEA - Gramercy LocationHouston, TN
Virginia Eye Consultants (VEC) - Norfolk OfficeNorfolk, VA
Toyos Clinic - NashvilleNashville, TN
OCLI (Ophthalmic Consultants of Long Island)Garden City, NY
More Trial Locations
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Who is running the clinical trial?
Dompé Farmaceutici S.p.ALead Sponsor