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

Condition(s) targeted: Dry Eye

Intervention: FML 0.1% eyedrops (Drug); Liquifilm artificial tears eyedrops (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Instituto Universitario de Oftalmobiología Aplicada

Official(s) and/or principal investigator(s):
Margarita Calonge-Cano, MD, PhD, Principal Investigator, Affiliation: Ocular surface group Director - IOBA

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.

Official title: Randomized, Double-Masked, Vehicle-controlled Phase III Trial on the Safety/Efficacy of FML® 0.1% in the Treatment of the Inflammatory Exacerbation Provoked by Exposure to an Adverse Controlled Environment in Patients With Dry Eye Disease

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Fluorescein corneal staining

Symptom Assessment in Dry Eye (SANDE) I and II questionnaire

Secondary outcome:

Tear inflammatory molecule levels

Best corrected visual acuity

Biomicroscopy findings at slit lamp examination

Adverse events during the trial

Other Efficacy Measures

Intraocular pressure (IOP) and fundus examination

Detailed description: 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

IOBA, Valladolid 47011, Spain

IOBA (Instituto de Oftalmobiología Aplicada), University of Valladolid, Valladolid 47011, Spain

Starting date: February 2014
Last updated: January 7, 2015