Prospective Evaluation of the Efficacy and Safety of Topical Hydrocortisone Treatment on Clinical Signs and Symptoms of Dry Eye Disease Associated With Moderate Meibomian Gland Dysfunction

THEA_HLF_1/21

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.

2021-11-09

2024-12-01

2025-03-01

Recruiting

Early phase I

54

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, authorize their participation in the study and sign an informed consent form before entering in the study Exclusion Criteria: 1. Any contraindication or known allergies to Lephanet®, Thealoz Duo®, MGD Rx EyeBag® or Softacort® 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 the study 11. Punctal occlusion 12. Intraocular pressure \> 22 mmHg 13. Patient who has received topical or systemic anti-inflammatory treatments including corticosteroids and nonsteroidal anti-inflammatory drugs (NSAIDS) within 3 months prior 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 the function of the meibomian gland and tear production within 3 months prior to be included 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 investigator discourages their participation in the study 17. Patient participating in any other interventional or non-interventional study or who have 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 the follow-up visits, way of life interfering with compliance)

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2024-03-13