MedTrace Logo

Piiloset Trehalose Emulsion Eye Drop Study in Moderate or Severe Dry Eye

NCT03569202 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2019-12-13

Study results available
· View outcomes & findings →

Summary

The study evaluates the safety, ocular tolerability and efficacy of emulsion eye drops with sacha inchi seed oil, trehalose and hyaluronic acid in the treatment of moderate or severe dry eye in adult patients. The investigative device is studied in comparison with control eye drops containing hyaluronic acid for up to 30 days.

Conditions

  • Dry Eye Syndrome

Interventions

DEVICE

Piiloset Trehalose Emulsion Eye Drops

Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops 3 times daily

DEVICE

Control Eye Drops

Topical application of preservative-free multidose Hyaluronic Acid Eye Drops 3 times daily

Sponsors & Collaborators

  • Finnsusp Ltd.

    collaborator INDUSTRY

  • 4Pharma Ltd.

    collaborator INDUSTRY

  • Business Finland

    collaborator OTHER

  • Kuopio University Hospital

    lead OTHER

Principal Investigators

  • Kai Kaarniranta, Professor · Kuopio University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-21
Primary Completion
2018-11-08
Completion
2018-11-08

Countries

  • Finland

Study Locations

More Related Trials

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 NCT03569202 on ClinicalTrials.gov