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

NCT02455999 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2016-04-05

No results posted yet for this study

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.

Conditions

  • Ocular Pain
  • Dry Eye Syndrome

Interventions

DRUG

SYL1001

SYL1001 eye drops dose C administration for 10 consecutive days

DRUG

SYL1001

SYL1001 eye drops dose D administration for 10 consecutive days

DRUG

Placebo

Placebo eye drops administration for 10 consecutive days

Sponsors & Collaborators

  • Sylentis, S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-03-31

Countries

  • Estonia
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02455999 on ClinicalTrials.gov