search
Back to results

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

Primary Purpose

Dry Eye

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
FML 0.1% eyedrops
Liquifilm artificial tears eyedrops
Sponsored by
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring keratoconjunctivitis sicca, dry eye, dry eye syndrome, dry eye disease, steroids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • IOBA (Instituto de Oftalmobiología Aplicada), University of Valladolid
  • IOBA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FML 0.1% eyedrops

Liquifilm artificial tears eyedrops

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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).
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
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
Adverse events during the trial
Adverse events that occur during the trial
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)
Intraocular pressure (IOP) and fundus examination
Intraocular pressure levels measured with a Goldman tonometer Evaluation of optic disk/cup ratio at fundus examination

Full Information

First Posted
January 22, 2014
Last Updated
January 7, 2015
Sponsor
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
search

1. Study Identification

Unique Protocol Identification Number
NCT02051023
Brief Title
Efficacy and Safety of Fluorometholone (FML) in Dry Eye Disease (Keratoconjunctivitis Sicca)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
keratoconjunctivitis sicca, dry eye, dry eye syndrome, dry eye disease, steroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FML 0.1% eyedrops
Arm Type
Experimental
Arm Description
FML (fluorometholone) 0.1% eyedrops 4 times a day in both eyes for 22 days
Arm Title
Liquifilm artificial tears eyedrops
Arm Type
Active Comparator
Arm Description
Topical application 4 times a day in both eyes for 22 days
Intervention Type
Drug
Intervention Name(s)
FML 0.1% eyedrops
Other Intervention Name(s)
0.1% fluorometholone
Intervention Description
Ocular topical application of fluorometholone 0.1% 4 times a day during 22 days
Intervention Type
Drug
Intervention Name(s)
Liquifilm artificial tears eyedrops
Other Intervention Name(s)
Artificial tears
Intervention Description
Liquifilm instillation 4 times a day for 22 days
Primary Outcome Measure Information:
Title
Fluorescein corneal staining
Description
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
Title
Symptom Assessment in Dry Eye (SANDE) I and II questionnaire
Description
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
Secondary Outcome Measure Information:
Title
Tear inflammatory molecule levels
Description
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
Title
Best corrected visual acuity
Description
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
Title
Biomicroscopy findings at slit lamp examination
Description
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
Title
Adverse events during the trial
Description
Adverse events that occur during the trial
Time Frame
22 days
Title
Other Efficacy Measures
Description
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
Title
Intraocular pressure (IOP) and fundus examination
Description
Intraocular pressure levels measured with a Goldman tonometer Evaluation of optic disk/cup ratio at fundus examination
Time Frame
22 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margarita Calonge-Cano, MD, PhD
Organizational Affiliation
Ocular surface group Director - IOBA
Official's Role
Principal Investigator
Facility Information:
Facility Name
IOBA (Instituto de Oftalmobiología Aplicada), University of Valladolid
City
Valladolid
ZIP/Postal Code
47011
Country
Spain
Facility Name
IOBA
City
Valladolid
ZIP/Postal Code
47011
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs