Pilot Study to Evaluate SYL1001 Safety and Effect in Patients With Ocular Pain

Dry Eye Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01776658
• Other study ID #: SYL1001_II
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 14, 2012
• Last updated: May 22, 2015
• Start date: November 2012

Study information

• Verified date: May 2015
• Source: Sylentis, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos SanitariosSpain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

The aim of this pilot study is to compare the analgesic effect of SYL1001 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: 60
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients of both genders

• Age = 18 years old

• Give written informed consent to participate in the study after having been informed of the study design, objectives and possible derived risks

• Common mild to moderate dry eye symptoms. Persistent daily symptoms for more than three months:

• OSDI scale: 13-30

• VAS scale: 2-7

• Ocular tests in both eyes:

• Corneal staining with fluorescein. Oxford scale > 0

• Tear Breakup Time Test: (BUT) < 10 seconds

• Schirmer test with anaesthesia < 10 mm/5min

Exclusion Criteria:

• Pregnant or breastfeeding females or those with a positive pregnancy test.

• Females of childbearing potential who will not use a medically acceptable contraceptive method from selection and during the whole study.

• Current relevant disease, including respiratory disease, cardiovascular, endocrine, neurological, haematological, renal, neoplasic, hepatopathy, gastrointestinal distress, hypertension, or infectious acute processes.

• Past history of a chronic o recurring condition that could interfere with study according to the investigator's judgement.

• Concomitant use of other drugs with analgesic activity by any route of administration at the enrolment period.

• Changes in any ocular and/or systemic concomitant medication one month prior to the study commencement and during the study development.

• Changes on the preestablished artificial tears dosage 15 days prior to the study commencement and during the study development.

• Cyclosporine treatment initiation or changes in cyclosporine dosage or dosing regimen during the 6 months prior to enrolment.

• Previous history of drug hypersensitivity.

• Use of contact lenses

• Case history of drug or alcohol abuse or dependence.

• Relevant abnormal laboratory results as judged by the investigator

• Previous refractive surgery

• Participation in a clinical trial within 2 months before the enrolment visit

• Relevant ocular pathology judged by the investigator.

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
Ocular topical administration of SYL1001 for 10 consecutive days
• Placebo
Ocular topical administration of placebo for 10 consecutive days

Locations

Country	Name	City	State
Spain	Fundación Jiménez Díaz	Madrid
Spain	Hospital Universitario Clínico San Carlos	Madrid
Spain	Instituto Oftalmológico Fernández-Vega	Oviedo

Sponsors (1)

Lead Sponsor	Collaborator
Sylentis, S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from Baseline in the Ocular Pain Scores on the Visual Analog Scale (VAS) and in the Ocular Discomfort Scores on the Ocular Surface Disease Index (OSDI) as a Measure of SYL1001 Analgesic Effect versus Placebo.		10 days + (4-10 days)	No
Primary	Simple Corneal and Conjunctival Evaluation as a Measure of Safety and Tolerability using Ophthalmic Dyes and a Slit Lamp		10 days + (4-10 days)	Yes
Secondary	Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability		10 days + (96-240 hours)	Yes
Secondary	Evaluation of Vital Signs, Blood, Urine and Ocular Parameters Alterations (IOP, Visual Acuity, Anterior Segment Exploration) Possibly Related to the Investigational Product		10 days + (96-240 hours)	Yes