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

NCT05159284 | Recruiting Phase 4

• 1 other identifier: THEA_HLF_1/21
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Eye; Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (2)

• Efficacy endpoint: Change from baseline in Meibomian Gland Dysfunction Dry Eye symptom score (MGD-DE) at 14 days

  Meibomian Gland Dysfunction Dry Eye symptom score (MGD-DE) calculated by the sum of the Visual Analogue scale (VAS) score assigned by the patient on a scale from 0 (no symptoms) to 100 (worst symptoms) in the following symptoms: itching, dry eye sensation, burning, foreign body sensation and ocular redness.

  Day 0 and Day 14

• Safety endpoint: Incidence of increased intraocular pressure and change from baseline at Day 0, Day 14, Day 28 and Day 84

  Mean of 3 measures of intraocular pressure measured with Goldmann tonometer in each eye on Day 0, Day 14, Day 28 and Day 84. Increased intraocular pressure defined as \>21 mmHg.

  Day 0, Day 14, Day 28 and Day 84

Secondary Outcomes (17)

• Change from baseline in Ocular Surface Disease Index (OSDI) questionnaire at Day 14, Day 28 and Day 84

  Day 0, Day 14, Day 28 and Day 84.

• Change from baseline in Meibomian Gland Dysfunction Dry Eye symptom score at Day 14, Day 28 and Day 84

  Day 0, Day 14, Day 28 and Day 84.

• Change from baseline in ocular symptoms Visual Analogue scale (VAS) questionnaire at Day 14, Day 28 and Day 84

  Day 0, Day 14, Day 28 and Day 84

• Change from baseline in hyperemia score (McMonnies-Chapman scale) at Day 14, Day 28 and Day 84.

  Day 0, Day 14, Day 28 and Day 84

• Change from baseline in Tear break up time (TBUT) at Day 14, Day 28 and Day 84

  Day 0, Day 14, Day 28 and Day 84

Study Arms (2)

Intervention group

EXPERIMENTAL

Softacort® Lephanet® Thealoz Duo® MGD Rx EyeBag®

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

Control group

OTHER

Lephanet® Thealoz Duo® MGD Rx EyeBag®

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

Interventions

Hydrocortisone Ophthalmic 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.

Also known as: Softacort®

Intervention group

MGD Rx EyeBag® eyelid warming device 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.

Also known as: Blepha EyeBag®

Control group; Intervention group

Lephanet® lid wipes 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.

Also known as: Blephaclean®

Control group; Intervention group

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

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

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Documented diagnosis of DE defined by TBUT value ≤ 5 seconds and Schirmer I test value \< 10 mm/5 min
• Normal ophthalmic findings except dry eye disease and meibomian gland dysfunction
• OSDI score \> 23 (moderate symptoms)
• Documented diagnosis of MGD grade 2 to 3
• Patient who can understand the instructions and adhere to medications
• 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

You may not qualify if:

• Any contraindication or known allergies to Lephanet®, Thealoz Duo®, MGD Rx EyeBag® or Softacort®
• Ocular surgery in the past 6 months
• Ocular hypertension or glaucoma
• Cicatricial MGD
• Atopic condition including ocular allergy
• Suspect demodex lid infestation as evidenced by the presence of collarettes
• Intraocular inflammation
• Confirmed infection with COVID-19 in the last 3 months
• Systemic autoimmune disorder
• Punctal occlusion
• Intraocular pressure \> 22 mmHg
• 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
• 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
• Any ocular or systemic disease known to affect the tear film other than MGD
• Patient with any situation or state that in the opinion of the investigator discourages their participation in the study

Sponsors & Collaborators

• Laboratorios Thea, Spain: lead

Study Sites (1)

Hospital La Fe

Valencia, 46026, Spain

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Study Officials

• Ana Hervas Ontiveros, Dr

  anheront@gmail.com

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Beatriz Greaves, Dr

CONTACT

+34934766810; maría.greaves@theapharma.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: December 16, 2021
• Study Start: November 9, 2021
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)