DOSE-FINDING STUDY TO ASSESS THE SAFETY AND EFFECT OF SYL1001 IN PATIENTS WITH OCULAR PAIN - NA

Sylentis0 sites60 target enrollmentApril 23, 2015

Overview

No summary available.

Registry

who.int

Start Date

April 23, 2015

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Sylentis

•\- 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.
•oOSDI scale between 13\-70
•oVAS scale between 2 ? 7
•\- Eye tests in both eyes until 15 days before inclusion:
•oCorneal fluorescein staining. Oxford scale \> 0
•oTear break\-up time (TBUT) \< 10 seconds
•oSchirmer?s test with anaesthesia \< 10 mm/5min

•\- 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.