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

NCT05159284 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-03-13

No results posted yet for this study

Summary

The purpose of this study is assess the efficacy and safety of topical hydrocortisone (Softacort) for treatment of clinical signs and symptoms of dry eye disease when associated with moderate meibomian gland dysfunction.

Conditions

  • Dry Eye
  • Meibomian 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.

Sponsors & Collaborators

  • Laboratorios Thea, Spain

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-09
Primary Completion
2024-12-31
Completion
2025-03-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05159284 on ClinicalTrials.gov