Dose-finding Study to Assess the Safety and Effect of SYL1001 in Patients With Ocular Pain

Dry Eye Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02455999
• Other study ID #: SYL1001_III
• 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. 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

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Eye Pain
• Keratoconjunctivitis Sicca
• Ocular Pain

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