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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02455999
Other study ID # SYL1001_III
Secondary ID
Status Completed
Phase Phase 2
First received May 20, 2015
Last updated April 4, 2016
Start date June 2015

Study information

Verified date April 2016
Source Sylentis, S.A.
Contact n/a
Is FDA regulated No
Health authority Estonia: Tallinn Medical Research Ethics Committee (TMREC)Estonia: State Agency of Medicines (RAVIMIAMET)Spain: Spanish Agency for Medicines and Health Products
Study type Interventional

Clinical Trial Summary

The aim of this pilot study is to compare the analgesic effect of two strengths of SYL1001 eye drops versus placebo in patients with ocular pain associated with Dry Eye Syndrome. General and local tolerability are also evaluated.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Give written informed 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: OSDI scale between 13-70 and VAS scale between 2 -7.

- Eye tests in both eyes: Corneal fluorescein staining (Oxford scale > 0), Tear break-up time < 10 seconds and Schirmer's test with anaesthesia < 10 mm/5min.

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
SYL1001
SYL1001 eye drops dose C administration for 10 consecutive days
SYL1001
SYL1001 eye drops dose D administration for 10 consecutive days
Placebo
Placebo eye drops administration for 10 consecutive days

Locations

Country Name City State
Estonia East Tallinn Central Hospital Tallinn
Estonia Eye Clinic Dr. Krista Turman Tallinn
Spain Fundación Jiménez Díaz Madrid
Spain Hospital U. Clínico San Carlos Madrid
Spain Hospital Universitario Ramón y Cajal Madrid
Spain Clínica Universidad de Navarra Pamplona

Sponsors (1)

Lead Sponsor Collaborator
Sylentis, S.A.

Countries where clinical trial is conducted

Estonia,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from the baseline scoring of eye pain on the Visual Analogue Scale (VAS) 10 consecutive days No
Primary Change from the baseline scoring of ocular discomfort in the Ocular Surface Disease Index (OSDI) 10 consecutive days No
Primary Change from the baseline scoring after fluorescein staining of the cornea 10 consecutive days Yes
Primary Frequency of occurrence of conjunctival hyperaemia 10 consecutive days Yes
Secondary Change from baseline in vital signs 10 consecutive days Yes
Secondary Change from baseline in standard laboratory parameters 10 consecutive days Yes
Secondary Assessment of Adverse Events (AEs) as a measure of SYL1001 safety 20 consecutive days Yes
Secondary Change from baseline in standard ocular parameters 10 consecutive days Yes
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