Tear Film Innovations iLux Safety Study

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)

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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