Moderate Dry Eye Syndrome
Conditions
Keywords
Dry Eye Syndrome
Brief summary
The purpose of this study is to determine if Thealoz is effective in Dry Eye Syndrome exposed to controlled adverse environmental conditions.
Interventions
OTHERThealoz
Instillation of 1 drop of Thealoz
OTHERVehicle
1 drop of the vehicle will be instillated in the eye
Sponsors
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Man/woman ≥ 18 years old, able to freely give consent to participate in the study * Fluorescein corneal staining ≥ 1 and ≤ 3 in Oxford Scales * At least 2 of the following tests altered: * Ocular Surface Disease Index (OSDI) Test symptoms between 12 and 40 * BUT ≤10 seconds * Lissamine green conjunctival staining ≥ 1 * Schirmer Test without anesthesia ≤ 5 mm * Informed consent signed * Data protection consent signed
Exclusion criteria
* Sensitivity or known intolerance to any of the product used in the study * Story of ocular infections or severe ocular inflammation within the 6 previous months to study inclusion * Any active ocular pathology other than Dry Eye Syndrome * Any traumatize or ocular surgery that may affect corneal sensitivity and/or normal tear distribution (e.g. cataract surgery, refractive surgery) within the 6 previous months to study inclusion * Use of contact lenses in the 3 previous months to study inclusion * Use of any ocular topical medications other than the treatment for Dry Eye Syndrome * Ocular treatment for Dry Eye Syndrome with corticosteroids 1 month before inclusion visit or Cyclosporin A 3 months before inclusion * Diagnosis of Rosacea or Severe Blepharitis (associated to systemic or ocular pathologies) Any severe uncontrolled systemic disease that may affect the eye (except for primary or secondary Sjögren) * Start, discontinuation or change within the study of the dosage of antihistaminics, cholinergic agents, beta blockers, anti depressants or any other systemic drugs with potential effects in the tear film * No pregnant or breastfeeding women is allowed to participate in the study. Childbearing potential women must use contraceptive means during the whole study. * Participation in another clinical trial in the last 30 days before study inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with fluorescein corneal staining reduction of at least 1 point | 1 Month | Proportion of subjects with staining reduction within the treatment group vs proportion of staining reduction in control group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Corrected Visual Acuity | 1 month | Best Corrected Visual Acuity at Exit visit compared to baseline visit |
| Intraocular pressure | 1 month | Pathological elevations of intraocular pressure from baseline |
| Eye fundus alterations | 1 month | Presence of any pathological finding in eye fundus while the patient is in the study |
| Corneal Pachymetry | 1 month | Changes in corneal thickness along the study |
Countries
Spain
Outcome results
None listed