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

There will be 4 visits in 3 different days:

Visit 1 (V1). Inclusion in normalized controlled environment (NCE)

Visit 2 (V2). 21 days post-treatment. Data collected in NCE

Visit 3 (V3). 21 days post-treatment. Data collected in adverse controlled environment (ACE)

Visit 4 (V4). 22 days post-treatment. Recovery visit in ACE. Data collected in NCE

Inclusion criteria

• Age > 18 years
• Signed informed consent
• Subjects refer worsening in their pathologies when exposed to adverse environmental conditions 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 changes in 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 study inclusion
• Any ocular pathology other than dry eye syndrome or atopic keratoconjunctivitis
• Any ocular surgery or trauma that may affect corneal sensitivity and / or normal tear distribution (refractive or cataract surgery) in the 6 previous months or any ocular or systemic surgery planned during the study duration that may affect the study as assessed 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 steroid anti-inflammatory drugs must have stopped 1 month before study inclusion. Any treatment with topical cyclosporin must have been stopped 3 months before study inclusion.
• Any uncontrolled severe systemic disease that may affect the eye (except for Sjögren Syndrome)
• Start, discontinuation or dose change during the study of antihistaminic, cholinergic agents, beta blockers, antidepressants or any other systemic medications with potential effect over tear film.
• Start of any systemic treatment that may affect dry eye syndrome, vision, ocular surface or intraocular pressure during the 3 previous months to study inclusion.
• Surgical / non surgical tear point occlusion in the 3 previous months to study inclusion 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