Efficacy and Safety of Fluorometholone (FML) in Dry Eye Disease (Keratoconjunctivitis Sicca)
FML
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
1 other identifier
interventional
41
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2014
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2014
CompletedFirst Posted
Study publicly available on registry
January 31, 2014
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJanuary 8, 2015
January 1, 2015
10 months
January 22, 2014
January 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (6)
Tear inflammatory molecule levels
22 days
Best corrected visual acuity
22 days
Biomicroscopy findings at slit lamp examination
22 days
Adverse events during the trial
22 days
Other Efficacy Measures
22 days
- +1 more secondary outcomes
Study Arms (2)
FML 0.1% eyedrops
EXPERIMENTALFML (fluorometholone) 0.1% eyedrops 4 times a day in both eyes for 22 days
Liquifilm artificial tears eyedrops
ACTIVE COMPARATORTopical application 4 times a day in both eyes for 22 days
Interventions
Ocular topical application of fluorometholone 0.1% 4 times a day during 22 days
Liquifilm instillation 4 times a day for 22 days
Eligibility Criteria
You may qualify if:
- 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
- Signed informed consent
- Signed data protection consent
You may not qualify if:
- Sensitivity or known intolerance to any of the products used in the study
- 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 any topical medication for pathologies other than dry eye syndrome.
- 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.
- Cup / disc ratio \> 0.6
- Pregnancy or breastfeeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
IOBA (Instituto de Oftalmobiología Aplicada), University of Valladolid
Valladolid, Valladolid, 47011, Spain
IOBA
Valladolid, Valladolid, 47011, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Margarita Calonge-Cano, MD, PhD
Ocular surface group Director - IOBA
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2014
First Posted
January 31, 2014
Study Start
February 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
January 8, 2015
Record last verified: 2015-01