Tear Film Innovations iLux Safety Study

NCT ID: NCT03055897

Last Updated: 2023-04-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-03

Study Completion Date

2016-05-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Meibomian Gland Dysfunction Evaporative Dry Eye

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

iLux 2020 System

Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual

Group Type EXPERIMENTAL

iLux 2020 System

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

iLux 2020 System

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- Sign written informed consent prior to study participation

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tear Film Innovations, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sr. CDMA Project Lead, CDMA Ocular Health

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

TearFilm Innovations Investigative Site

Encinitas, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.