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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
41
Ocular topical application of fluorometholone 0.1% 4 times a day during 22 days
Liquifilm instillation 4 times a day for 22 days
IOBA (Instituto de Oftalmobiología Aplicada), University of Valladolid
Valladolid, Valladolid, Spain
IOBA
Valladolid, Valladolid, Spain
Fluorescein corneal staining
Evidence of statistically significant changes in the number of subjects with an increase ≥ 1 point in fluorescein corneal staining between pre and post adverse condition exposure in ACE (V2 vs V3) and between post adverse condition exposure in ACE and recovery visit (V3 vs V4).
Time frame: 22 days
Symptom Assessment in Dry Eye (SANDE) I and II questionnaire
Evidence of statistically significant changes in the number of subjects with a reduction ≥ 2 points in SANDE score between pre and post adverse condition exposure in ACE (V2 vs V3) and between post adverse condition exposure and recovery visit (V3 vs V4).
Time frame: 22 days
Tear inflammatory molecule levels
Evidence of statistically significant changes between the differences in tear molecule concentrations pre and post adverse condition exposure (V2 vs V3) in ACE and between post adverse condition exposure and recovery visit (V3 vs V4).
Time frame: 22 days
Best corrected visual acuity
Best corrected visual acuity measured with the ETDRS (Eearly Treatment for Diabetes Retinopathy Study) chart after 22 days of treatment compared to baseline
Time frame: 22 days
Biomicroscopy findings at slit lamp examination
Biomicroscopy findings (general aspect of ocular surface and anterior segment, plus corneal and conjunctival staining) after 22 days of treatment compared to baseline
Time frame: 22 days
Adverse events during the trial
Adverse events that occur during the trial
Time frame: 22 days
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Other Efficacy Measures
Conjunctival Staining (Lissamine Green; Oxford Scale) T-BUT (tear break-up time) Conjunctival hyperemia (Efron Scale) Patient satisfaction with the treatment (VAS 0-100)
Time frame: 22 days
Intraocular pressure (IOP) and fundus examination
Intraocular pressure levels measured with a Goldman tonometer Evaluation of optic disk/cup ratio at fundus examination
Time frame: 22 days