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Evaluation of the efficacy and safety of topical treatment on clinical signs and symptoms of dry eye disease associated with moderate meibomian gland dysfunction.
EU CTIS ID: 2024-518093-13-00
What this study is testing
Efficacy: To compare change in MGD-DE symptom score from baseline (D0) to Day 14 (D14) in patients with DE and moderate MGD treated with lid hygiene, artificial tears, and a medical device (BlephaEyeBag®) with or without hydrocortisone. Exploratory: To compare change in Inflammatory cytokines level in tears from baseline to Day 14. Safety: Incidence of increased intraocular pressure (IOP) between D0, D14, D28 and D84.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Documented diagnosis of DE defined by TBUT value ≤ 5 seconds
- 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
You likely can't join if
- Any contraindication or known allergies to Lephanet®, Thealoz Duo®, BlephaEyeBag® or Softacort® as per SmPC
- Systemic autoimmune disorder.
- Punctal occlusion
- IOP > 22mmHg
- Patient who has received topical anti-inflammatory treatments including corticosteroids and nonsteroidal anti-inflammatory drugs (NSAIDS) within 6 weeks prior to be included in the study or with a prescription for receiving topical anti-inflammatory treatments for the next 3 months
- 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
See the full eligibility criteria
- Age ≥ 18 years
- Documented diagnosis of DE defined by TBUT value ≤ 5 seconds
- 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 ICF before entering in the study
- Any contraindication or known allergies to Lephanet®, Thealoz Duo®, BlephaEyeBag® or Softacort® as per SmPC
- Systemic autoimmune disorder.
- Punctal occlusion
- IOP > 22mmHg
- Patient who has received topical anti-inflammatory treatments including corticosteroids and nonsteroidal anti-inflammatory drugs (NSAIDS) within 6 weeks prior to be included in the study or with a prescription for receiving topical anti-inflammatory treatments for the next 3 months
- 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
- 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
- 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
- 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 the follow-up visits, way of life interfering with compliance)
- Use of contact lenses during the month prior to inclusion in the study or during the study
- 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
- Patient with current symptoms suggestive of Covid-19.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.