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

May 22, 2015 updated by: Sylentis, S.A.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Fundacion Jimenez Diaz
      • Madrid, Spain, 28040
        • Hospital Universitario Clinico San Carlos
      • Oviedo, Spain, 33012
        • Instituto Oftalmológico Fernández-Vega

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SYL1001 eye drops dose A
Ocular topical administration of SYL1001 eye drops dose A
Drug: SYL1001
Ocular topical administration of SYL1001 for 10 consecutive days
PLACEBO_COMPARATOR: Placebo
Ocular topical administration of placebo eye drops
Drug: Placebo
Ocular topical administration of placebo for 10 consecutive days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability
Time Frame: 10 days + (96-240 hours)
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
Time Frame: 10 days + (96-240 hours)
10 days + (96-240 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sylentis, S.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

November 14, 2012

First Submitted That Met QC Criteria

January 23, 2013

First Posted (ESTIMATE)

January 28, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 25, 2015

Last Update Submitted That Met QC Criteria

May 22, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYL1001_II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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