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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-09

Study Completion Date

2025-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dry Eye Meibomian Gland Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Phase IV, interventional, prospective, randomized, single blind, of parallel groups with two treatment arms clinical trial in one center.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

This is a single-blinded study for the PI or person designated to conduct the study (blinded investigator). Study medication will be labelled as blinded medication. The prescription will be done by the blinded investigator using a kit number, and study medication delivery will be done by a person designed by the PI for this topic through the study (unblinded collaborator). Patients will be instructed not to inform the investigators who perform the ophthalmological evaluation about the group they will be assigned to. Patient assessments will be performed by blinded investigator.

Study Groups

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Intervention group

Softacort® Lephanet® Thealoz Duo® MGD Rx EyeBag®

Group Type EXPERIMENTAL

Hydrocortisone Ophthalmic

Intervention Type DRUG

1 drop 4 times daily for 12 days, followed by twice daily for 2 days and stop, for a total of 14 days of treatment. Repeat on day 28: 1 drop 4 times daily for 12 days, followed by twice daily for 2 days and stop. Patients in the intervention arm will receive two 14-day cycles of hydrocortisone.

MGD Rx EyeBag® eyelid warming device

Intervention Type DEVICE

Eyelid warming device used once daily for 10 minutes followed by lid massage for 12 weeks by patients in both control and intervention arm.

Lephanet® lid wipes

Intervention Type DEVICE

Lid hygiene with Lephanet® lid wipes used twice daily for 3 weeks followed by once daily for 9 more weeks by patients in both control and intervention arm.

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

Intervention Type DEVICE

Artificial tear supplementation with Thealoz Duo® 4 times daily for 12 weeks by patients in both control and intervention arm.

Control group

Lephanet® Thealoz Duo® MGD Rx EyeBag®

Group Type OTHER

MGD Rx EyeBag® eyelid warming device

Intervention Type DEVICE

Eyelid warming device used once daily for 10 minutes followed by lid massage for 12 weeks by patients in both control and intervention arm.

Lephanet® lid wipes

Intervention Type DEVICE

Lid hygiene with Lephanet® lid wipes used twice daily for 3 weeks followed by once daily for 9 more weeks by patients in both control and intervention arm.

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

Intervention Type DEVICE

Artificial tear supplementation with Thealoz Duo® 4 times daily for 12 weeks by patients in both control and intervention arm.

Interventions

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Hydrocortisone Ophthalmic

1 drop 4 times daily for 12 days, followed by twice daily for 2 days and stop, for a total of 14 days of treatment. Repeat on day 28: 1 drop 4 times daily for 12 days, followed by twice daily for 2 days and stop. Patients in the intervention arm will receive two 14-day cycles of hydrocortisone.

Intervention Type DRUG

MGD Rx EyeBag® eyelid warming device

Eyelid warming device used once daily for 10 minutes followed by lid massage for 12 weeks by patients in both control and intervention arm.

Intervention Type DEVICE

Lephanet® lid wipes

Lid hygiene with Lephanet® lid wipes used twice daily for 3 weeks followed by once daily for 9 more weeks by patients in both control and intervention arm.

Intervention Type DEVICE

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

Artificial tear supplementation with Thealoz Duo® 4 times daily for 12 weeks by patients in both control and intervention arm.

Intervention Type DEVICE

Other Intervention Names

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Softacort® Blepha EyeBag® Blephaclean®

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No