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

Last updated: March 12, 2024
Sponsor: Laboratorios Thea, Spain
Overall Status: Active - Recruiting

Phase

4

Condition

Blepharitis

Eyelid Inflammation

Dry Eyes

Treatment

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

Hydrocortisone Ophthalmic

Lephanet® lid wipes

Clinical Study ID

NCT05159284
THEA_HLF_1/21
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Documented diagnosis of DE defined by TBUT value ≤ 5 seconds and Schirmer I test value < 10 mm/5 min
  3. Normal ophthalmic findings except dry eye disease and meibomian gland dysfunction
  4. OSDI score > 23 (moderate symptoms)
  5. Documented diagnosis of MGD grade 2 to 3
  6. Patient who can understand the instructions and adhere to medications
  7. Patient who receives complete information regarding the study objectives, authorizetheir participation in the study and sign an informed consent form before entering inthe study

Exclusion

Exclusion Criteria:

  1. Any contraindication or known allergies to Lephanet®, Thealoz Duo®, MGD Rx EyeBag® orSoftacort®
  2. Ocular surgery in the past 6 months
  3. Ocular hypertension or glaucoma
  4. Cicatricial MGD
  5. Atopic condition including ocular allergy
  6. Suspect demodex lid infestation as evidenced by the presence of collarettes
  7. Intraocular inflammation
  8. Confirmed infection with COVID-19 in the last 3 months
  9. Systemic autoimmune disorder
  10. Use of contact lenses during the month prior to inclusion in the study or during thestudy
  11. Punctal occlusion
  12. Intraocular pressure > 22 mmHg
  13. Patient who has received topical or systemic anti-inflammatory treatments includingcorticosteroids and nonsteroidal anti-inflammatory drugs (NSAIDS) within 3 monthsprior to be included in the study or with a prescription for receiving topical /systemic anti-inflammatory treatments for the next 3 months
  14. In the investigator´s opinion, use of systemic medications that could affect thefunction of the meibomian gland and tear production within 3 months prior to beincluded in the study
  15. Any ocular or systemic disease known to affect the tear film other than MGD
  16. Patient with any situation or state that in the opinion of the investigatordiscourages their participation in the study
  17. Patient participating in any other interventional or non-interventional study or whohave participated in another study within 30 days prior to inclusion in this study
  18. Women who are pregnant, planning to become pregnant or breastfeeding
  19. Patient who will not be able to complete the study (e.g., not willing to attend thefollow-up visits, way of life interfering with compliance)

Study Design

Total Participants: 54
Treatment Group(s): 4
Primary Treatment: Thealoz Duo® artificial tear with trehalose 3% and sodium hyaluronate 0.15%
Phase: 4
Study Start date:
November 09, 2021
Estimated Completion Date:
March 31, 2025

Study Description

This is a prospective, interventional, randomized (1:1), single blind, of parallel groups and two treatment arms clinical trial (phase IV).

All patients diagnosed with dry eye disease (DED) associated with moderate MGD may participate in the study if they meet all the selection criteria.

Patients (or their representatives) will provide informed consent (IC) prior to the enrolment in the study and to the start of data collection. Patients must meet all the inclusion criteria and not meet any of the exclusion criteria.

Connect with a study center

  • Hospital La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

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