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

Phase 1

• Conditions: Patients with eye pain associated to dry eye; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2014-004857-15-EE
• Lead Sponsor: Sylentis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-23
• Last Update Posted: 1 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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.
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified