Topical hydrocortisone for treating dry eye linked to meibomian gland dysfunction
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
This study is testing if a hydrocortisone eye treatment can help people with dry eyes caused by meibomian gland dysfunction feel better compared to standard care.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Laboratorios Thea, Spain Industry-sponsored |
| Locations | 1 site (Valencia) |
| Trial ID | NCT05159284 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of topical hydrocortisone in alleviating the signs and symptoms of dry eye disease associated with moderate meibomian gland dysfunction. It is a phase IV, prospective, interventional study with a randomized, single-blind design involving two treatment arms. Participants will receive either hydrocortisone ophthalmic treatment or standard care, and their responses will be monitored through various ophthalmic assessments. The study aims to provide insights into the effectiveness of hydrocortisone for this specific condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a documented diagnosis of dry eye disease and moderate meibomian gland dysfunction.
Not a fit: Patients with contraindications to the study treatments, recent ocular surgery, or other specific ocular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from dry eye disease linked to meibomian gland dysfunction.
How similar studies have performed: While there have been studies on various treatments for dry eye disease, the specific use of topical hydrocortisone for this condition is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Valencia
- Hospital La Fe — Valencia, Spain (Recruiting)
Study contacts
- Principal investigator: Ana Hervas Ontiveros, Dr — anheront@gmail.com
- Study coordinator: Maria Beatriz Greaves, Dr
- Email: maría.greaves@theapharma.com
- Phone: +34934766810
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.