Study to Evaluate Safety and Efficacy of Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

January 27, 2022

Primary Completion Date

May 24, 2023

Study Completion Date

May 24, 2023

Conditions
Dry Eye Disease
Interventions
DRUG

Cenegermin

Oxervate®, an ophthalmic solution containing cenegermin 20 mcg/mL, which is a recombinant human Nerve Growth Factor (rhNGF); one drop of the test product will be instilled in both eyes three times daily (TID) for 28 consecutive days.

OTHER

Vehicle

Vehicle was instilled with the same scheme of the test product

Trial Locations (10)

11530

OCLI (Ophthalmic Consultants of Long Island), Garden City

19104

Scheie Eye Institute, Philadelphia

20123

Università degli Studi di Milano - Ospedale San Giuseppe - UO Oculistica, Milan

21218

The Johns Hopkins University, Baltimore

37215

Toyos Clinic - Nashville, Nashville

77025

Houston Eye Associates HEA - Gramercy Location, Houston

91204

Lugene Eye Institute - Glendale Office, Glendale

95123

AOU Gaspare Rodolico - Ospedale San Marco, Catania

02111

Tufts University School of Medicine (TUSM) - New England Eye Center/Tufts Medical Center, Boston

00161

AOU Policlinico Umberto I - Dipartimento Organi di Senso - Clinica Oculistica, Roma

All Listed Sponsors
lead

Dompé Farmaceutici S.p.A

INDUSTRY