Dry EyePhase 3FMLNCT02051023
Efficacy and Safety of Fluorometholone (FML) in Dry Eye Disease (Keratoconjunctivitis Sicca)
A Phase 3 study testing FML 0.1% eyedrops and Liquifilm artificial tears eyedrops in people with Dry Eye, run by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- FML 0.1% eyedrops and Liquifilm artificial tears eyedrops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesSpain
- Study dates
- Feb 2014to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
IOBA (Instituto de Oftalmobiología Aplicada), University of Valladolid
Valladolid, Valladolid, 47011
IOBA
Valladolid, Valladolid, 47011
About this study
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
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.
Read the 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
- Conditions
- Dry Eye
- Being tested
- FML 0.1% eyedrops, Liquifilm artificial tears eyedrops
- Keywords
- keratoconjunctivitis sicca, dry eye, dry eye syndrome, dry eye disease, steroids
- Medical subject headings
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FML 0.1% eyedropsDrug
Also called 0.1% fluorometholone
Ocular topical application of fluorometholone 0.1% 4 times a day during 22 days
Liquifilm artificial tears eyedropsDrug
Also called Artificial tears
Liquifilm instillation 4 times a day for 22 days
| Study group | Role | What they receive |
|---|---|---|
| FML 0.1% eyedrops | Experimental | FML (fluorometholone) 0.1% eyedrops 4 times a day in both eyes for 22 days Receives: Drug: FML 0.1% eyedrops |
| Liquifilm artificial tears eyedrops | Active comparator | Topical application 4 times a day in both eyes for 22 days Receives: Drug: Liquifilm artificial tears eyedrops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 22 days
Secondary outcomes (6)
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).
Measured: 22 days
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
Measured: 22 days
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
Measured: 22 days
Adverse events during the trial
Adverse events that occur during the trial
Measured: 22 days
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)
Measured: 22 days
Intraocular pressure (IOP) and fundus examination
Intraocular pressure levels measured with a Goldman tonometer Evaluation of optic disk/cup ratio at fundus examination
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margarita Calonge-Cano, MD, PhD, Principal investigator, Ocular surface group Director - IOBA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051023
- Sponsor's protocol ID
- IOBA-CERLAB-003-2013
- Acronym
- FML
- Status last verified
- Jan 2015
- First submitted
- 22 Jan 2014
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02051023
- Acronym / sponsor ID
- FML / IOBA-CERLAB-003-2013
- Conditions
- Dry Eye
- Keywords
- keratoconjunctivitis sicca, dry eye, dry eye syndrome, dry eye disease, steroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBAUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 31 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FML 0.1% eyedrops | Experimental | Drug: FML 0.1% eyedropsFML (fluorometholone) 0.1% eyedrops 4 times a day in both eyes for 22 days |
| Liquifilm artificial tears eyedrops | Active comparator | Drug: Liquifilm artificial tears eyedropsTopical application 4 times a day in both eyes for 22 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FML 0.1% eyedropsAlso: 0.1% fluorometholoneOcular topical application of fluorometholone 0.1% 4 times a day during 22 days | Drug | FML 0.1% eyedrops |
| Liquifilm artificial tears eyedropsAlso: Artificial tearsLiquifilm instillation 4 times a day for 22 days | Drug | Liquifilm artificial tears eyedrops |
Primary outcome
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).
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).
6 secondary outcomes
Tear inflammatory molecule levels
Time frame: 22 days
Best corrected visual acuity
Time frame: 22 days
Biomicroscopy findings at slit lamp examination
Time frame: 22 days
Adverse events during the trial
Time frame: 22 days
Other Efficacy Measures
Time frame: 22 days
Intraocular pressure (IOP) and fundus examination
Time frame: 22 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margarita Calonge-Cano, MD, PhD principal investigator
Ocular surface group Director - IOBA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FML 0.1% eyedrops and Liquifilm artificial tears eyedrops in people with Dry Eye, run by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluorescein corneal staining (time frame: 22 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2015.