Dry eye syndrome (DES) MedDRA version: 16.0 Level: LLT Classification code 10013777 Term: Dry eye syndrome System Organ Class: 10015919 - Eye disorders MedDRA version: 16.0 Level: PT Classification code 10013774 Term: Dry eye System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: FML
Pharmaceutical Form: Eye drops, suspension
Trade Name: Liquifilm Artificial Teardrop
Pharmaceutical Form: Eye drops, solution
Sponsors
IOBA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient = 18 years old Worsening of pathology when exposed to adverse environmental conditions during normal life Corneal staining = 1 in both eyes using Oxford Scale OSDI symptoms > 12 points TBT = 7 seconds in both eyes Schirmer Test without anesthesia = 10 mm after 5 minutes in both eyes. Any medication that may affect DES, ocular surface or vision must have started at least 3 months before inclusion and no dose changes are expected during study BCVA at least 0.1 logMar at 6 meters with both eyes Use of artificial teardrops at inclusion Signed informed consent prior to any study procedure Signed Data protection form prior to any study procedure 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 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: Known sensitivity or intolerance to any of the products used in the study Story of ocular infection or inflammation during the 6 previous months to study inclusion Any active ocular pathology (except dry eye syndrome) Any ocular surgery or trauma that may affect corneal sensitivity and/or normal tear distribution (cataract or refractive surgery) within the 6 previous months to study inclusion or any ocular o systemic surgery planned to happen during the study thay in the investigator´s opinion may jeopardize the study Use of contact lenses within 3 months prior to study inclusion Use of any topical medication except those used for DES Ocular treatment for DES with corticosteroids or non-steroid antiinflamatories within 1 month prior to study inclusion or 3 months before inclusion in case of treatment with Cyclosporin Any uncontrolled systemic disease that may affect the eye (except primary or secondary Sjögren Syndrome) Start, discontinuation or dose change within the study of antihistaminics, cholinergic agents, beta-blockers, antidepressants or any other medication with potential effect over tear film Start of any systemic treatment that may affect DES, vision, ocular surface or intraocular pressure, during the 3 previous months to study inclusion Occlusion of lacrimal points, surgical or non surgical, in the 3 previous months of study inclusion or expected necessity of occlusion during the study Cup / Disc ration > 0.6 Story of glaucoma or intraocular pressure > 22mm Hg in any measurement done within the 2 previous months to study inclusion Pregnancy or breastfeeding women Participation in any clinical trial within the last 30 days before study inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the efficacy under adverse controlled environmental conditions of FML in dry eye syndrome;Secondary Objective: Assess and compare ocular surface staining (corneal and conjunctival) with the study product and the comparator Assess and compare dry eye symptoms with OSDI and SANDE with the study product and the comparator Assess and compare user satisfaction with an 0-100 analog scale with the study product and the comparator Assess and compare tear film by Tear Breakup Time Test (TBT) with the study product and the comparator Assess and compare visual function with ETDRS visual acuity test with the study product and the comparator Assess and compare changes in intraocular pressure and eye fundus with the study product and the comparator Assess ocular, orbitary and systemic adverse events Assess every serious adverse event during the study ;Timepoint(s) of evaluation of this end point: 1a) 7 days of treatment after normalization conditions 1b) 7 days of treatment after adverse conditions 2) After 7 days of treatment ;Primary end point(s): A) Fluorescein corneal staining I.- Proportion of subjects with corneal staining reduction = 1 point after normalization environmental conditions after 7 days of treatment with test drug vs same conditions with control product. II.- Proportion of subjects with corneal staining increase = 1 point after exposure to adverse conditions after 7 days of use of study treatment with test drug vs same conditions with control product B) SANDE I and II questionnaries. Proportion of subjects with reduction of = 2 puntos in SANDE after 7 days of treatment with test drug vs same conditions with control product. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A) Tear protein levels: I.- Evidence of statistically significant changes in any of the studied molecules before and after treatment after exposure to normal conditions for both treatments. II.- Evidence of statistically significant changes in any of the studied molecules before and after treatment after exposure to adverse conditions and after recovery visit for both treatments.;Timepoint(s) of evaluation of this end point: 1) After exposure to normal conditions 2) after exposure to adverse conditions and after recovery visit | — |
Countries
Spain
Contacts
Public ContactClinical Trials Unit
IOBA
Outcome results
None listed