Safety and Efficacy of Two Different Concentrations (0.5% and 1%) of Progesterone Topical Gel Compared to Placebo in Patients Diagnosed With Moderate to Severe Dry Eye Syndrome

PHASE2CompletedINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

February 18, 2021

Primary Completion Date

October 27, 2022

Study Completion Date

October 27, 2022

Conditions
Dry Eye Disease
Interventions
DRUG

Pro-ocular gel

Topical gel in multidose formulation to be applied laterally to the forehead twice a day, morning and night for 3 months

DRUG

Placebo gel

Topical gel in multidose formulation to be applied laterally to the forehead twice a day, morning and night for 3 months

Trial Locations (4)

20157

Ospedale Luigi Sacco Polo Universitario - Oculistica, Milan

50134

A.O.U. Careggi Firenze - SOD Oculistica, Florence

98125

Azienda Ospedaliera Universitaria Policlinico G. Martino - UOC di Oftalmologia, Messina

95121,

Ospedale San Marco - Azienda Ospedaliera Universitaria, Catania

All Listed Sponsors
lead

SIFI SpA

INDUSTRY

NCT04645446 - Safety and Efficacy of Two Different Concentrations (0.5% and 1%) of Progesterone Topical Gel Compared to Placebo in Patients Diagnosed With Moderate to Severe Dry Eye Syndrome | Biotech Hunter | Biotech Hunter