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

Sylentis0 sites60 target enrollmentMarch 27, 2015

Overview

No summary available.

Registry

who.int

Start Date

March 27, 2015

End Date

TBD

Last Updated

10 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.