Patients with eye pain associated to dry eye
Conditions
Sponsors
Sylentis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients aged ? 18 years - Men or women (individuals of either sex can participate in the study) - Have submitted their written consent to participate in the study, after having received all information relating to the design, aims and possible risks resulting therefrom. - Common symptoms of persistent, daily, mild to moderate dry eye lasting more than three months. o OSDI scale between 13-70 o VAS scale between 2 ? 7 - Eye tests in both eyes until 15 days before inclusion: o Corneal fluorescein staining. Oxford scale > 0 o Tear break-up time (TBUT) =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: - Women who are pregnant or breastfeeding or who have a positive urine pregnancy test. Women who do not commit to use a medically acceptable method of contraception from the time of selection and throughout the study. - Any current, relevant disease, including respiratory disease, cardiovascular disease, endocrine disease, neurological disease, haematological disease, kidney disease, oncological disease, liver disease, gastrointestinal dysfunction, hypertension or active acute infectious processes. - Previous chronic or recurrent processes which, according to the investigator, could affect the development of the study. - Concomitant use of other medications with analgesic activity by any route of administration at the time of entry into the study. - Change in any concomitant eye and/or systemic medication of the patient one month before the study and during the study. - Changes in the pre-established administration schedule of artificial tears during the 15 days before the study and during the 10 days of the study. - Initiation of treatment with cyclosporine or changes in the dosage or administration schedule of cyclosporine within the 6 months before inclusion in the study. - History of hypersensitivity to drugs. - Use of contact lenses during the treatment and previous 15 days. - History of drug abuse or drug or alcohol dependence. - Laboratory abnormalities which, in the investigator?s opinion, are clinically significant. - Previous refractive surgery. - Having participated in another clinical trial within the 2 months prior to inclusion. - Another eye disease that is significant in the investigator?s opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To assess the analgesic effect of different doses of SYL1001 ophthalmic solution. - Ocular tolerance at the site of administration (cornea and conjunctiva) after 10 days of treatment.;Secondary Objective: ? Assessment of systemic tolerance. Impact of the treatment (change from the baseline) in blood and urine parameters, the physical examination and in vital signs after 10 days of treatment. ? Assessment of local tolerance. Impact of the treatment (change from the baseline) in ocular parameters (visual acuity, intraocular pressure (IOP), Schirmer?s test and tear break-up time) ? Assessment of Adverse Events (AEs) occurred;Primary end point(s): Assessment of the analgesic effect - The change from the baseline scoring on the VAS scale after 10 days of treatment. - The change from the baseline in the scoring of the OSDI questionnaire after 10 days of treatment. Assessment of local tolerance - The frequency of new abnormalities occurring at the site of administration (cornea and conjunctiva);Timepoint(s) of evaluation of this end point: After 10 days of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Assessment of systemic tolerance. The impact of treatment (change from the baseline) in the blood and urine parameters, the physical examination and in vital signs after 10 days of treatment. The impact of treatment (change from the baseline) in the remaining local tolerance parameters (anterior eye examination, visual acuity and IOP) after 10 days of treatment. Assessment of AEs. All AEs occurring during the study will be recorded.;Timepoint(s) of evaluation of this end point: After 10 days of treatment | — |
Countries
Estonia, Spain
Contacts
Public ContactAsuntos Regulatorios
Sylentis
Outcome results
None listed