Evaluating Impact of Systane iLux on Dryness Symptoms and Wearing Time in Contact Lens Users

November 14, 2023 updated by: Periman Eye Institute

A Single Arm, Single Center Phase 4 Study to Evaluate Impact of a Single Systane iLux MGD Treatment Device Thermal Pulsation Treatment on Contact Lens Wearing Time and Tolerability, Meibomian Gland Secretion Scores, and Subjective Dry Eye Symptoms in Soft Contact Lens Wearing Subjects With Meibomian Gland Dysfunction

To evaluate dry eye symptoms and contact lens wearing times after a single iLux treatment by evaluating change from baseline in OSDI scores, subjective CLDEQ8 and CL wearing time questionnaires, and meibomian gland secretion scores.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A single arm, single center phase 4 study to evaluate impact of a single Systane iLux MGD Treatment Device thermal pulsation treatment on contact lens wearing time and tolerability, meibomian gland secretion scores, and subjective dry eye symptoms in soft contact lens wearing subjects with meibomian gland dysfunction.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98119
        • Recruiting
        • Periman Eye Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Laura M Periman, MD
        • Sub-Investigator:
          • Sathi Maiti, OD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Eligible subjects must be 18 years of age or older
  2. Eligible subjects must be willing and able to provide an English language written Informed Consent Form
  3. Be a current soft contact lens wearer for at least 2-18 hours a day 4-7 days a week but experiencing contact lens discomfort that limits the number of hours of comfortable contact lens wear.
  4. Have worn the same commercially available soft contact lens (material, base curve, diameter) for the previous 90 days
  5. Have new contact lens to wear starting the first day after iLux treatment
  6. Have an OSDI score greater than ≥ 12
  7. Have a CLDEQ8 score ≥ 12
  8. Have a minimum meibomian gland expression score ≤ 12 (using MGD scoring system: apply pressure with korb expressor to 15 glands of lower lid (5 nasal, 5 central, 5 temporal): each gland will be scored from 0 to 3 (0 = no secretion, 1 = inspissated, 2 = cloudy, 3 = clear liquid), sum of score from each gland with equal total score, total score will range from 0-45.
  9. Be able and willing to follow instructions and participate in all trial assessments and visits
  10. Eligible subjects must be fully vaccinated against COVID-19

Exclusion Criteria:

  1. Have any clinically significant slit-lamp findings at Visit 1 that in the opinion of the investigator may interfere with trial parameters
  2. Have abnormal lid anatomy eg. entropion, ectropion or active lid lesion eg. hordeolum, chalazion that may interfere with administering iLux treatment
  3. Had Lipiflow, iLux, Tear Care or manual meibomian gland expression in the last 30 days
  4. Be a woman who is pregnant, nursing, or planning a pregnancy
  5. Had ocular surgery within the last 90 days
  6. Have used topical cyclosporine, lifitegrast, topical or facial steroids, serum tears, or oral doxycycline or tetracycline within the last 30 days before Visit 1
  7. Had Intense Pulsed Light (IPL) treatment within last 30 days
  8. Have active ocular infection or inflammation
  9. Be a current wearer of extended wear contact lenses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1
Single arm trial
Procedure: Systane iLux thermal pulsation treatment
Systane iLux thermal pulsation uses light emitting diode (LED) technology to emit light that is absorbed by pigments (melanin and hemoglobin) in the eyelid. The pigments convert the light energy to heat, which is then transferred to the surrounding tissues, including the meibomian glands. The device heats the eyelid to 40-42°C and maintains it above 40°C during the heating period, which can be 40 seconds or more. This helps melt the meibum. After the heating phase, the meibomian glands are expressed with the built in expression system.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of subjects with improvment in OSDI Questionnaire score from baseline to 1 month
Time Frame: 1 month
OSDI (Ocular Surface Disease Index) is a subjective dry eye symptom questionnaire. A lower OSDI score represents less frequent and/or less severe symptoms.
1 month
Percentage of subjects with improvement in CLDEQ8 Questionnaire score from baseline to 1 month
Time Frame: 1 month
CLDEQ8 (Contact Lens Dry Eye Questionnaire) is a subjective contact lens discomfort and dryness questionnaire. A lower CLDEQ8 score represents less frequent and/or less severe symptoms
1 month
Percentage of subjects with improvement in MGSS from baseline to 1 month
Time Frame: 1 month
MGSS (Meibomian gland secretion score). To determine the meibomian gland score, secretion characteristics of 15 meibomian glands along the lower eyelid were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/ toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range between 0 and 45. A higher score reflects less meibomian gland dysfunction.
1 month
Percentage of subjects with improvement in comfortable SCL (soft contact lens) wearing time from baseline to 1 month
Time Frame: 1 month
Total comfortable soft contact lens wearing time per week will be asked via questionnaire.
1 month
Percentage of subjects with dryness symptoms who reported wearing their contact lenses longer, 1 month post treatment.
Time Frame: 1 month
Total soft contact lens wearing time per week will be asked via questionnaire.
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean change in Sodium Fluorescein and Lussamine Green staining from baseline to 1 month
Time Frame: 1 month
Mean change in ocular surface staining (sodium fluorescein and lissamine green) from baseline as measured by the National Eye Institute and Oxford grading scales.
1 month
Mean change in TBUT from baseline to 1 month
Time Frame: 1 month
The investigator instilled sodium fluorescein into the lower eyelid and asked the patient to blink several times, then stop. The time between the last blink and the first appearance of a dark spot on the cornea (formation of a dry area) on the otherwise continuously stained tear film was recorded in seconds. 3 consecutive measurements were taken, with TBUT defined as the average of the 3 measurements. A positive change value represents A positive change value represents a more stable tear film (improvement). Eyes were assessed individually.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Periman Eye Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 26, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PEI-IIT-70111343

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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