Clinical trial NCT05159284: Efficacy and Safety of Topical Hydrocortisone on Signs and Symptoms of Dry Eye Associated to Meibomian Gland Dysfunction
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Dry Eye
Meibomian Gland Dysfunction
Lead sponsor: Laboratorios Thea, Spain
Sponsor class: INDUSTRY
First posted: 2021-12-16
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase IV, interventional, prospective, randomized, single blind, of parallel groups with two treatment arms clinical trial in one center.
Primary purpose: TREATMENT

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.

Detailed 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.

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)

Primary outcomes:
measure: Efficacy endpoint: Change from baseline in Meibomian Gland Dysfunction Dry Eye symptom score (MGD-DE) at 14 days
timeFrame: Day 0 and Day 14
measure: Safety endpoint: Incidence of increased intraocular pressure and change from baseline at Day 0, Day 14, Day 28 and Day 84
timeFrame: Day 0, Day 14, Day 28 and Day 84
Secondary outcomes:
measure: Change from baseline in Ocular Surface Disease Index (OSDI) questionnaire at Day 14, Day 28 and Day 84
timeFrame: Day 0, Day 14, Day 28 and Day 84.
measure: Change from baseline in Meibomian Gland Dysfunction Dry Eye symptom score at Day 14, Day 28 and Day 84
timeFrame: Day 0, Day 14, Day 28 and Day 84.
measure: Change from baseline in ocular symptoms Visual Analogue scale (VAS) questionnaire at Day 14, Day 28 and Day 84
timeFrame: Day 0, Day 14, Day 28 and Day 84
measure: Change from baseline in hyperemia score (McMonnies-Chapman scale) at Day 14, Day 28 and Day 84.
timeFrame: Day 0, Day 14, Day 28 and Day 84
measure: Change from baseline in Tear break up time (TBUT) at Day 14, Day 28 and Day 84
timeFrame: Day 0, Day 14, Day 28 and Day 84
measure: Change from baseline in corneal and conjunctival staining with fluorescein (Oxford grading scale) at Day 14, Day 28 and Day 84
timeFrame: Day 0, Day 14, Day 28 and Day 84
measure: Change from baseline in corneal and conjunctival staining with lissamine green (Van Bijsterveld scale) at Day 14, Day 28 and Day 84
timeFrame: Day 0, Day 14, Day 28 and Day 84
measure: Change from baseline in meniscus height at Day 14, Day 28 and Day 84
timeFrame: Day 0, Day 14, Day 28 and Day 84
measure: Change from baseline in Schirmer I test at Day 14, Day 28 and Day 84
timeFrame: Day 0, Day 14, Day 28 and Day 84
measure: Change from baseline in MGD grading at Day 14, Day 28 and Day 84
timeFrame: Day 0, Day 14, Day 28 and Day 84
measure: Change from baseline in lid abnormalities at Day 14, Day 28 and Day 84
timeFrame: Day 0, Day 14, Day 28 and Day 84
measure: Change from baseline in Eyelid telangiectasia score at Day 14, Day 28 and Day 84
timeFrame: Day 0, Day 14, Day 28 and Day 84
measure: Change from baseline in Lissamine green staining score at Day 14, Day 28 and Day 84
timeFrame: Day 0, Day 14, Day 28 and Day 84
measure: Change from baseline in Meibomian gland expressibility score at Day 14, Day 28 and Day 84
timeFrame: Day 0, Day 14, Day 28 and Day 84
measure: Change from baseline in tear inflammatory cytokines at Day 14
timeFrame: Day 0 and Day 14.
measure: Incidence of adverse events and serious adverse events occurred during the study.
timeFrame: Day 0, Day 14, Day 28 and Day 84
measure: Change from baseline in ETDRS visual acuity at Day 14, Day 28 and Day 84
timeFrame: Day 0, Day 14, Day 28 and Day 84
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital La Fe
Study officials:
affiliation: anheront@gmail.com
name: Ana Hervas Ontiveros, Dr
role: PRINCIPAL_INVESTIGATOR
References: