Efficacy and Safety of Fluorometholone (FML) in Dry Eye Disease (Keratoconjunctivitis Sicca)

Inclusion Criteria:

• Age > 18 years

• Signed informed consent

• Subjects refer worsening in their pathologies when exposed to adverse environmentalconditions in their daily life

• Fluorescein corneal staining ≥ 1in Oxford Scale

• Ocular surface disease index (OSDI) test > 12

• Tear breakup Time (TBT) ≤ 7 seconds in both eyes

• Schirmer test without anesthesia ≤ 10 mm in 5 minutes in both eyes

• Any concomitant medication that may affect dry eye syndrome, ocular surface or vision,must have started at least 3 months before screening visit, and there are no changesin dose expected during the study duration.

• Best corrected visual acuity at least 0.1 logMar at 6 meters with both eyes

• Current use of ophthalmic artificial tears at study inclusion.

• Signed informed consent

• Signed data protection consent

Exclusion Criteria:

• Sensitivity or known intolerance to any of the products used in the study

• Previous severe ocular inflammation or infections in the 6 previous months to studyinclusion

• Any ocular pathology other than dry eye syndrome or atopic keratoconjunctivitis

• Any ocular surgery or trauma that may affect corneal sensitivity and / or normal teardistribution (refractive or cataract surgery) in the 6 previous months or any ocularor systemic surgery planned during the study duration that may affect the study asassessed by principal investigator.

• Use of contact lenses in the 3 previous months to study inclusion

• Use of any topical medication for pathologies other than dry eye syndrome.

• Any ocular topical treatment for dry eye syndrome with corticosteroids or non steroidanti-inflammatory drugs must have stopped 1 month before study inclusion. Anytreatment with topical cyclosporin must have been stopped 3 months before studyinclusion.

• Any uncontrolled severe systemic disease that may affect the eye (except for SjögrenSyndrome)

• Start, discontinuation or dose change during the study of antihistaminic, cholinergicagents, beta blockers, antidepressants or any other systemic medications withpotential effect over tear film.

• Start of any systemic treatment that may affect dry eye syndrome, vision, ocularsurface or intraocular pressure during the 3 previous months to study inclusion.

• Surgical / non surgical tear point occlusion in the 3 previous months to studyinclusion or prevision during study duration for this procedure.

• Cup / disc ratio > 0.6

• History of intraocular pressure > 22 mm Hg within 2 months previous to study inclusion

• Pregnancy or breastfeeding women

• Inclusion in another research study in the previous 30 days to study inclusion