Evaluation of the efficacy and safety of topical treatment on clinical signs and symptoms of dry eye disease associated with moderate meibomian gland dysfunction”

Phase 1

• Conditions: Dry Eye (DE) and Meibomian gland dysfunction (MGD); MedDRA version: 21.1Level: PTClassification code 10013774Term: Dry eyeSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 20.1Level: PTClassification code 10065062Term: Meibomian gland dysfunctionSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2021-003469-36-ES
• Lead Sponsor: aboratorios Théa, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-15
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 54

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 DED and MGD
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 a written informed consent form (ICF) before entering in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 27

Exclusion Criteria

1.Any contraindication or known allergies to Lephanet®, Thealoz Duo®, MGD Rx EyeBag ® or Softacort® as per SmPC
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.IOP > 22mmHg
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 MG 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified