Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FML 0.1% eyedrops | Experimental | FML (fluorometholone) 0.1% eyedrops 4 times a day in both eyes for 22 days |
|
| Liquifilm artificial tears eyedrops | Active Comparator | Topical application 4 times a day in both eyes for 22 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FML 0.1% eyedrops | Drug | Ocular topical application of fluorometholone 0.1% 4 times a day during 22 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Best corrected visual acuity |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Margarita Calonge-Cano, MD, PhD | Ocular surface group Director - IOBA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IOBA (Instituto de OftalmobiologÃa Aplicada), University of Valladolid | Valladolid | Valladolid | 47011 | Spain | ||
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D007638 | Keratoconjunctivitis Sicca |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D007637 | Keratoconjunctivitis |
| D003231 | Conjunctivitis |
Not provided
Not provided
| ID | Term |
|---|---|
| D005469 | Fluorometholone |
| D009883 | Ophthalmic Solutions |
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Liquifilm artificial tears eyedrops | Drug | Liquifilm instillation 4 times a day for 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 |
| 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 | 22 days |
| Adverse events during the trial | Adverse events that occur during the trial | 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) | 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 | 22 days |
| IOBA |
| Valladolid |
| Valladolid |
| 47011 |
| Spain |
| D003229 |
| Conjunctival Diseases |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D054327 | Lubricants |