Tear Film Innovations iLux Safety Study

T

Tear Film Innovations

Status

Completed

Conditions

Meibomian Gland Dysfunction
Evaporative Dry Eye

Treatments

Device: iLux 2020 System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03055897
2020-02

Details and patient eligibility

About

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.

Full description

Alcon Research, LLC, acquired TearFilm Innovations, Inc., in December 2018. This study was designed and conducted by TearFilm Innovations, Inc. The study results were collected, analyzed, and provided by TearFilm Innovations, Inc., to Alcon Research, LLC.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

- Sign written informed consent prior to study participation

Key Exclusion Criteria:

  • History of ocular surgery within 1 year
  • Active ocular infection
  • Ocular surface abnormality; lid surface abnormalities
  • Pregnant, nursing or not utilizing adequate birth control measures
  • Other protocol-specified exclusion criteria may apply

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

iLux 2020 System
Experimental group
Description:
Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
Treatment:
Device: iLux 2020 System

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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