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

Sponsor

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA (Other)

Overall Status

Completed

CT.gov ID

NCT02051023

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

20.5

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Drug: FML 0.1% eyedrops Drug: Liquifilm artificial tears eyedrops	Phase 3

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

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FML 0.1% eyedrops FML (fluorometholone) 0.1% eyedrops 4 times a day in both eyes for 22 days	Drug: FML 0.1% eyedrops Ocular topical application of fluorometholone 0.1% 4 times a day during 22 days Other Names: 0.1% fluorometholone
Active Comparator: Liquifilm artificial tears eyedrops Topical application 4 times a day in both eyes for 22 days	Drug: Liquifilm artificial tears eyedrops Liquifilm instillation 4 times a day for 22 days Other Names: Artificial tears

Arm

Intervention/Treatment

Experimental: FML 0.1% eyedrops

FML (fluorometholone) 0.1% eyedrops 4 times a day in both eyes for 22 days

Drug: FML 0.1% eyedrops

Ocular topical application of fluorometholone 0.1% 4 times a day during 22 days

Other Names:

0.1% fluorometholone

Active Comparator: Liquifilm artificial tears eyedrops

Topical application 4 times a day in both eyes for 22 days

Drug: Liquifilm artificial tears eyedrops

Liquifilm instillation 4 times a day for 22 days

Other Names:

Artificial tears

Outcome Measures

Primary Outcome Measures

Fluorescein corneal staining [22 days]
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).
Symptom Assessment in Dry Eye (SANDE) I and II questionnaire [22 days]
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).

Secondary Outcome Measures

Tear inflammatory molecule levels [22 days]
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).
Best corrected visual acuity [22 days]
Best corrected visual acuity measured with the ETDRS (Eearly Treatment for Diabetes Retinopathy Study) chart after 22 days of treatment compared to baseline
Biomicroscopy findings at slit lamp examination [22 days]
Biomicroscopy findings (general aspect of ocular surface and anterior segment, plus corneal and conjunctival staining) after 22 days of treatment compared to baseline
Adverse events during the trial [22 days]
Adverse events that occur during the trial
Other Efficacy Measures [22 days]
Conjunctival Staining (Lissamine Green; Oxford Scale) T-BUT (tear break-up time) Conjunctival hyperemia (Efron Scale) Patient satisfaction with the treatment (VAS 0-100)
Intraocular pressure (IOP) and fundus examination [22 days]
Intraocular pressure levels measured with a Goldman tonometer Evaluation of optic disk/cup ratio at fundus examination

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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