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

Dry Eye Clinical Trial

— FML  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02051023
• Other study ID #: IOBA-CERLAB-003-2013
• Status: Completed
• Phase: Phase 3
• First received: January 22, 2014
• Last updated: January 7, 2015
• Start date: February 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Instituto Universitario de Oftalmobiología Aplicada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca

Intervention

Drug:
• FML 0.1% eyedrops
Ocular topical application of fluorometholone 0.1% 4 times a day during 22 days
• Liquifilm artificial tears eyedrops
Liquifilm instillation 4 times a day for 22 days

Locations

Country	Name	City	State
Spain	IOBA	Valladolid
Spain	IOBA (Instituto de Oftalmobiología Aplicada), University of Valladolid	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Universitario de Oftalmobiología Aplicada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	22 days	No
Primary	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).	22 days	No
Secondary	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).	22 days	No
Secondary	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	22 days	Yes
Secondary	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	22 days	Yes
Secondary	Adverse events during the trial	Adverse events that occur during the trial	22 days	Yes
Secondary	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)	22 days	No
Secondary	Intraocular pressure (IOP) and fundus examination	Intraocular pressure levels measured with a Goldman tonometer Evaluation of optic disk/cup ratio at fundus examination	22 days	Yes