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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Laboratorios Thea S.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

26 Oct 2021 → 16 Jul 2025

Decision date (initial)

2024-10-21

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Laboratorios Théa, S.A.

External identifiers

EU CT number

2024-518093-13-00

EudraCT number

2021-003469-36

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

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.

Secondary objectives 5

1. Efficacy: To assess ocular symptoms of DE and MGD measured by: • change in OSDI score between D0 and D14, D28 and D84 • change in VAS score of 7 symptoms (itching, dry eye sensation, burning, foreign body sensation, ocular redness, ocular fatigue, and blurry vision) between D0 and D14, D28 and D84.
2. Efficacy: To assess ocular signs of ocular surface disease: • conjunctival hyperemia measured with the McMonnies-Chapman scale • tear film stability measured by TBUT test • ocular surface damage measured by fluorescein corneal and conjunctival staining (Oxford grading scale) • ocular surface damage measured by lissamine corneal and conjunctival staining (Van Bijsterveld scale) • tear volume (Schirmer I test)
3. Efficacy: To assess ocular signs of MGD: • Grading of MGD • Lid abnormalities including irregularity, thickness, and plugging. • Eyelid telangiectasia
4. Safety: To assess the safety of the medication received by the patient.
5. Safety: Change in visual acuity between D0, D14, D28 and D84.

Conditions and MedDRA coding

Dry Eye and Meibomian Gland Dysfunction

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Age ≥ 18 years
2. Documented diagnosis of DE defined by TBUT value ≤ 5 seconds
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 ICF before entering in the study

Exclusion criteria 19

1. Any contraindication or known allergies to Lephanet®, Thealoz Duo®, BlephaEyeBag® or Softacort® as per SmPC
2. Use of contact lenses during the month prior to inclusion in the study or during the study
3. Ocular surgery in the past 6 months.
4. Ocular hypertension or glaucoma.
5. Cicatricial MGD
6. Atopic condition including ocular allergy
7. Suspect demodex lid infestation as evidenced by the presence of collarettes
8. Intraocular inflammation
9. Patient with current symptoms suggestive of Covid-19.
10. Systemic autoimmune disorder.
11. Punctal occlusion
12. IOP > 22mmHg
13. 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
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)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Efficacy: Change in MGD-DE symptom score from D0 to D14.
2. Exploratory: Change from D0 value to D14 (both eyes) in level of the following inflammatory cytokines in tears: IL-6, TNF alpha, IL-1b, IL-10, IFNγ, IL-17A, IL-2, IL-4. First eye to sample will be the study eye.
3. Safety: Incidence of increased intraocular pressure (IOP). Change in IOP between D0, D14, D28 and D84.

Secondary endpoints 4

1. Efficacy: Ocular Symptoms • Change in OSDI score between D0 and D14, D28 and D84. • Change in MGD-DE symptom score from D0 to D28 and D84. • Change in VAS score of each of 7 symptoms (itching, dry eye sensation, burning, foreign body sensation, ocular redness, ocular fatigue, and blurry vision) between D0 and D14, D28 and D84.
2. Efficacy: Ocular signs of DED • Change in hyperemia score (McMonnies – Chapman scale) between D0 and D14, D28 and D84. • Change in TBUT between D0 and D14, D28 and D84. • Change in corneal and conjunctival staining with fluorescein (Oxford grading scale) between D0 and D14, D28 and D84. • Change in corneal and conjunctival staining with lissamine green (Van Bijsterveld scale) between D0 and D14, D28 and D84. • Change in Schirmer I test between D0 and D14, D28 and D84.
3. Efficacy: Ocular signs of MGD • Change in grading of MGD according to a graduation from 0 to 4 between D0 and D84. • Change in lid abnormality score according to a graduation from 0 to 2, where 0 is no findings and 2 is severe findings, between D0 an
4. Safety: • Incidence of adverse events (AE) and serious adverse events (SAE) occurred during the study. • Change in visual acuity between D0, D14, D28 and D84. Early Treatment Diabetic Retinopathy Study (ETDRS) scale will be used.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Laboratorios Thea S.A.

Sponsor organisation

Laboratorios Thea S.A.

Address

Calle D'enric Granados 86-88 Planta 2

City

Barcelona

Postcode

08008

Country

Spain

Scientific contact point

Organisation

Laboratorios Thea S.A.

Contact name

Medical Affairs

Public contact point

Organisation

Laboratorios Thea S.A.

Contact name

Medical Affairs

Third parties 1

Locations

1 EU/EEA country · 10 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications