EUCTR2021-003469-36-ES
Active, Not Recruiting
Phase 1
Prospective evaluation of the efficacy and safety of topical hydrocortisone treatment on clinical signs andsymptoms of dry eye disease associated with moderate meibomian gland dysfunction” - SOFT–MGD
aboratorios Théa, S.A.0 sites54 target enrollmentJuly 15, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- aboratorios Théa, S.A.
- Enrollment
- 54
- Status
- Active, Not Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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