Last updated: March 12, 2024
Sponsor: Laboratorios Thea, Spain
Overall Status: Active - Recruiting
Phase
4
Condition
Blepharitis
Eyelid Inflammation
Dry Eyes
Treatment
Thealoz Duo® artificial tear with trehalose 3% and sodium hyaluronate 0.15%
Hydrocortisone Ophthalmic
Lephanet® lid wipes
Clinical Study ID
NCT05159284
THEA_HLF_1/21
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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, authorizetheir participation in the study and sign an informed consent form before entering inthe study
Exclusion
Exclusion Criteria:
- Any contraindication or known allergies to Lephanet®, Thealoz Duo®, MGD Rx EyeBag® orSoftacort®
- 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
- Use of contact lenses during the month prior to inclusion in the study or during thestudy
- Punctal occlusion
- Intraocular pressure > 22 mmHg
- Patient who has received topical or systemic anti-inflammatory treatments includingcorticosteroids and nonsteroidal anti-inflammatory drugs (NSAIDS) within 3 monthsprior 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 thefunction of the meibomian gland and tear production within 3 months prior to beincluded 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 investigatordiscourages their participation in the study
- Patient participating in any other interventional or non-interventional study or whohave participated in another study within 30 days prior to inclusion in this study
- Women who are pregnant, planning to become pregnant or breastfeeding
- Patient who will not be able to complete the study (e.g., not willing to attend thefollow-up visits, way of life interfering with compliance)
Study Design
Total Participants: 54
Treatment Group(s): 4
Primary Treatment: Thealoz Duo® artificial tear with trehalose 3% and sodium hyaluronate 0.15%
Phase: 4
Study Start date:
November 09, 2021
Estimated Completion Date:
March 31, 2025
Study Description
Connect with a study center
Hospital La Fe
Valencia, 46026
SpainActive - Recruiting
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