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

Launched by LABORATORIOS THEA, SPAIN · Dec 2, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness and safety of a medication called topical hydrocortisone (Softacort) for treating dry eye symptoms linked to a condition known as meibomian gland dysfunction (MGD). Dry eye disease can cause discomfort and vision problems, and MGD affects the glands in the eyelids that help produce tears. The study aims to help those experiencing moderate symptoms of dry eye related to MGD.

To participate in this trial, you need to be at least 18 years old and have been diagnosed with dry eye disease and MGD. You should not have certain eye conditions, recent eye surgeries, or allergies to specific medications. If eligible, you can expect to apply the hydrocortisone treatment and attend follow-up visits to monitor your symptoms. Participants will receive thorough information about the study and must give their consent before joining. This research could contribute to finding better treatments for dry eye disease in the future.

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Eligibility criteria

• 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)