Efficacy and Safety of Topical Hydrocortisone on Signs and Symptoms of Dry Eye Associated to Meibomian Gland Dysfunction

PHASE4RecruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

November 9, 2021

Primary Completion Date

December 31, 2024

Study Completion Date

March 31, 2025

Conditions
Dry EyeMeibomian Gland Dysfunction
Interventions
DRUG

Hydrocortisone Ophthalmic

1 drop 4 times daily for 12 days, followed by twice daily for 2 days and stop, for a total of 14 days of treatment. Repeat on day 28: 1 drop 4 times daily for 12 days, followed by twice daily for 2 days and stop. Patients in the intervention arm will receive two 14-day cycles of hydrocortisone.

DEVICE

MGD Rx EyeBag® eyelid warming device

Eyelid warming device used once daily for 10 minutes followed by lid massage for 12 weeks by patients in both control and intervention arm.

DEVICE

Lephanet® lid wipes

Lid hygiene with Lephanet® lid wipes used twice daily for 3 weeks followed by once daily for 9 more weeks by patients in both control and intervention arm.

DEVICE

Thealoz Duo® artificial tear with trehalose 3% and sodium hyaluronate 0.15%

Artificial tear supplementation with Thealoz Duo® 4 times daily for 12 weeks by patients in both control and intervention arm.

Trial Locations (1)

46026

RECRUITING

Hospital La Fe, Valencia

Sponsors
All Listed Sponsors
lead

Laboratorios Thea, Spain

INDUSTRY

NCT05159284 - Efficacy and Safety of Topical Hydrocortisone on Signs and Symptoms of Dry Eye Associated to Meibomian Gland Dysfunction | Biotech Hunter | Biotech Hunter