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

Phase 1

Completed

• Conditions: Dry Eye Syndrome; Ocular Pain
• Interventions: Drug: SYL1001; Drug: Placebo

• Registration Number: NCT01776658
• Lead Sponsor: Sylentis, S.A.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-14
• Study First Submitted QC: 2013-01-23
• Study First Posted: 2013-01-28
• Primary Completion: 2015-04
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-22
• Last Update Posted: 2015-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SYL1001 eye drops dose A	SYL1001	Ocular topical administration of SYL1001 eye drops dose A
Placebo	Placebo	Ocular topical administration of placebo eye drops

Primary Outcome Measures

Name	Time	Method
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)
Simple Corneal and Conjunctival Evaluation as a Measure of Safety and Tolerability using Ophthalmic Dyes and a Slit Lamp	10 days + (4-10 days)

Secondary Outcome Measures

Name	Time	Method
Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability	10 days + (96-240 hours)
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)

Trial Locations

Locations (3)

Hospital Universitario Clínico San Carlos; 🇪🇸 Madrid, Spain

Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain

Instituto Oftalmológico Fernández-Vega; 🇪🇸 Oviedo, Spain