Dry Eye (DE) and Meibomian gland dysfunction (MGD) MedDRA version: 21.1 Level: PT Classification code 10013774 Term: Dry eye System Organ Class: 10015919 - Eye disorders MedDRA version: 20.1 Level: PT Classification code 10065062 Term: Meibomian gland dysfunction System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Softacort
Product Name: Softacort
Pharmaceutical Form: Eye drops
INN or Proposed INN: HYDROCORTISONE SODIUM PHOSPHATE
CAS Number: 6000-74-4
Concentration unit: mg/ml milligram(s)/millilitr
Sponsors
Laboratorios Théa, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years 2. Documented diagnosis of DE defined by TBUT value = 5 seconds and Schirmer I test value 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -Efficacy objective: To compare change in MGD-DE symptom score (defined as the sum of the Visual Analogue Scale (VAS) score obtained from each of the following symptoms: itching, dry eye sensation, burning, foreign body sensation and ocular redness), from baseline (D0) to Day 14 (D14) in patients with DE and moderate MGD treated with lid hygiene, artificial tears, and a medical device (MGD Rx EyeBag®) with or without hydrocortis-one. -Safety objective: Incidence of increased intraocular pressure (IOP) between D0, D14, D28 and D84.;Secondary Objective: -Efficacy objective: •To assess ocular symptoms of DE and MGD measured by: change in OSDI score change in VAS score of each of 7 symptoms •To assess ocular signs of ocular surface disease: conjunctival hyperemia measured with the McMonnies-Chapman scale tear film stability measured by tear breakup time test ocular surface damage measured by fluorescein corneal and conjunctival staining ocular surface damage measured by lissamine green corneal and conjunctival staining tear meniscus height tear volume •To assess ocular signs of MGD: Grading of MGD Lid abnormalities including irregularity, thickness, and plugging Eyelid telangiectasia Lissamine green staining of lid margin Meibomian gland expressibility •Inflammatory cytokine level in tears -Safety Objectives:To assess the safety of the medication received by the patient and Change in visual acuity;Primary end point(s): -Efficacy: Change in MGD-DE symptom score from D0 to D14. -Safety: Incidence of increased intraocular pressure (IOP). Change in IOP between D0, D14, D28 and D84.;Timepoint(s) of evaluation of this end point: For all primary endpoints: from day 1 to day 84. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: For all secundary endpoints: from day 1 to day 84.;Secondary end point(s): Efficacy endpoints: 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. 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 value of tear meniscus height between D0 and D14, D28 and D84. • Change in Schirmer I test between D0 and D14, D28 and D84. Ocular signs of MGD • Change in grading of MGD according to a graduation from 0 to 4 where 0 is no meibomian gland dropout and expressed meibum with clear appearance and 4 is with gland dropout of more than half the lid margin or complete keratinization of the ducts and no expression of meibum. • Change in lid abnormality score (irregularity, thickness and plugging) according to a graduation from 0 to 2, where 0 is no findings and 2 is severe findings. • Change in Eyelid telangiectasia score according to a graduation from 0 to 3, where 0 is no findings and 3 is severe findings, between D0 and D14, D28 and D84. • Change in lissamine green staining of lid margin score between D0 and D14, D28 and D84. • Change in MG expressibility between D0 and D14, D28 and D84. Inflamatory Cytokines • 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, IFN?, IL-17A, IL-2, IL-4. First eye to sample will be the study eye. Safet | — |
Countries
Spain
Contacts
Public ContactMaría Greaves
Laboratorios Théa, S.A.
Outcome results
None listed