NCT03982368 - A Study to Evaluate Safety and Efficacy of rhNGF Eye Solution vs Vehicle in Patients With Moderate to Severe Dry Eye | Biotech Hunter

Enrollment

261

Participants

Timeline

Start Date

June 10, 2019

Primary Completion Date

July 15, 2020

Study Completion Date

July 15, 2020

Conditions

Dry Eye Syndrome

Interventions

DRUG

rhNGF 20 μg/ml

one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)

DRUG

rhNGF 20 μg/ml + vehicle

"one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).~rhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon."

OTHER

Vehicle

one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)

Trial Locations (12)

11702

SightMD, Babylon

30260

Clayton Eye Clinical Research, LLC, Morrow

37027

Toyos Clinic, Nashville

40517

Kentucky Eye Institute, Lexington

64111

Tauber Eye Center, Kansas City

64154

Moyes Eye Center, Kansas City

77025

Houston Eye Associates HEA - Gramercy Location, Houston

77034

Advanced Laser Vision Surgical Institute (Study Site) Intouch Clinical Research Center (SMO), Houston

91204

Global Research Management, Glendale

92647

Sierra Clinical Trials & Research Organization, Santa Ana

92663

Eye Research Foundation, Newport Beach

95670

Martel Eye Medical Group, Rancho Cordova

All Listed Sponsors

lead

Dompé Farmaceutici S.p.A

INDUSTRY