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Trial record 67 of 8752 for:    Eye AND Eye Diseases

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

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ClinicalTrials.gov Identifier: NCT02051023
Recruitment Status : Completed
First Posted : January 31, 2014
Last Update Posted : January 8, 2015
Sponsor:
Information provided by (Responsible Party):
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

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


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Study Type : Interventional  (Clinical Trial)
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 : February 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases 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 Name: 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 Name: Artificial tears




Primary Outcome Measures :
  1. Fluorescein corneal staining [ Time Frame: 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).

  2. Symptom Assessment in Dry Eye (SANDE) I and II questionnaire [ Time Frame: 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 :
  1. Tear inflammatory molecule levels [ Time Frame: 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).

  2. Best corrected visual acuity [ Time Frame: 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

  3. Biomicroscopy findings at slit lamp examination [ Time Frame: 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

  4. Adverse events during the trial [ Time Frame: 22 days ]
    Adverse events that occur during the trial

  5. Other Efficacy Measures [ Time Frame: 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)

  6. Intraocular pressure (IOP) and fundus examination [ Time Frame: 22 days ]
    Intraocular pressure levels measured with a Goldman tonometer Evaluation of optic disk/cup ratio at fundus examination



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02051023


Locations
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Spain
IOBA (Instituto de Oftalmobiología Aplicada), University of Valladolid
Valladolid, Spain, 47011
IOBA
Valladolid, Spain, 47011
Sponsors and Collaborators
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Investigators
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Principal Investigator: Margarita Calonge-Cano, MD, PhD Ocular surface group Director - IOBA

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Responsible Party: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
ClinicalTrials.gov Identifier: NCT02051023     History of Changes
Other Study ID Numbers: IOBA-CERLAB-003-2013
First Posted: January 31, 2014    Key Record Dates
Last Update Posted: January 8, 2015
Last Verified: January 2015

Keywords provided by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA:
keratoconjunctivitis sicca
dry eye
dry eye syndrome
dry eye disease
steroids

Additional relevant MeSH terms:
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Dry Eye Syndromes
Eye Diseases
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Lubricant Eye Drops
Ophthalmic Solutions
Keratoconjunctivitis Sicca
Keratoconjunctivitis
Conjunctivitis
Keratitis
Fluorometholone
Pharmaceutical Solutions
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents