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Tear Film Innovations iLux Safety Study

NCT03055897 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-04-12

Study results available
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Summary

The objective of this study was to measure the temperature of the cornea and surrounding eye tissue temperature immediately after heating the eyelids with the iLux device using the protocol treatment profile. Eligible participants attended one treatment visit, with follow-up one day following the procedure.

Conditions

  • Meibomian Gland Dysfunction
  • Evaporative Dry Eye

Interventions

DEVICE

iLux 2020 System

Medical device that applies localized heat and pressure therapy to the eyelid in order to express melted meibum from obstructed glands

Sponsors & Collaborators

  • Tear Film Innovations, Inc.

    lead INDUSTRY

Principal Investigators

  • Sr. CDMA Project Lead, CDMA Ocular Health · Alcon Research, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-03
Primary Completion
2016-05-17
Completion
2016-05-18
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03055897 on ClinicalTrials.gov