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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Hypothesis: Fluorometholone (FML) 0.1% eyedrops topically applied 4 times a day for 22 days is more efficient than artificial tears (Liquifilm) in dry eye disease (DED) and ameliorates the worsening of the disease after exposure to an adverse controlled environment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
• Treatments: Fluorometholone; Lubricant Eye Drops; Ophthalmic Solutions; Tetrahydrozoline

Criteria

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