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

Thea Pharma

Status and phase: Enrolling; Phase 4

Conditions: Dry Eye; Meibomian Gland Dysfunction

Treatments: Device: Thealoz Duo® artificial tear with trehalose 3% and sodium hyaluronate 0.15%; Device: MGD Rx EyeBag® eyelid warming device; Drug: Hydrocortisone Ophthalmic; Device: Lephanet® lid wipes

Study type: Interventional

Funder types: Industry

Identifiers

NCT05159284

THEA_HLF_1/21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups

Intervention group

Experimental group

Description:

Softacort® Lephanet® Thealoz Duo® MGD Rx EyeBag®

Treatment:

Device: Lephanet® lid wipes

Device: MGD Rx EyeBag® eyelid warming device

Drug: Hydrocortisone Ophthalmic

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

Control group

Other group

Description:

Lephanet® Thealoz Duo® MGD Rx EyeBag®

Treatment:

Device: Lephanet® lid wipes

Device: MGD Rx EyeBag® eyelid warming device

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