Moderate Dry Eye Syndrome Clinical Trial
Official title:
Evaluation of the Efficacy and Safety of a Treatment for Dry Eye Syndrome: Thealoz
The purpose of this study is to determine if Thealoz is effective in Dry Eye Syndrome exposed to controlled adverse environmental conditions.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | June 2014 |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | IOBA - University of Valladolid | Valladolid |
| Lead Sponsor | Collaborator |
|---|---|
| Instituto Universitario de Oftalmobiología Aplicada |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of patients with fluorescein corneal staining reduction of at least 1 point | Proportion of subjects with staining reduction within the treatment group vs proportion of staining reduction in control group | 1 Month | No |
| Secondary | Best Corrected Visual Acuity | Best Corrected Visual Acuity at Exit visit compared to baseline visit | 1 month | Yes |
| Secondary | Intraocular pressure | Pathological elevations of intraocular pressure from baseline | 1 month | Yes |
| Secondary | Eye fundus alterations | Presence of any pathological finding in eye fundus while the patient is in the study | 1 month | Yes |
| Secondary | Corneal Pachymetry | Changes in corneal thickness along the study | 1 month | Yes |