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

Primary Purpose

Meibomian Gland Dysfunction, Dry Eye

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Systane iLux thermal pulsation treatment

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction focused on measuring dry eye disease, meibomian gland dysfunction, ilux, thermal pulsation, contact lens

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Eligible subjects must be 18 years of age or older
Eligible subjects must be willing and able to provide an English language written Informed Consent Form
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.
Have worn the same commercially available soft contact lens (material, base curve, diameter) for the previous 90 days
Have new contact lens to wear starting the first day after iLux treatment
Have an OSDI score greater than ≥ 12
Have a CLDEQ8 score ≥ 12
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.
Be able and willing to follow instructions and participate in all trial assessments and visits
Eligible subjects must be fully vaccinated against COVID-19

Exclusion Criteria:

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

Sites / Locations

Periman Eye InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Single arm trial

Outcomes

Primary Outcome Measures

Percentage of subjects with improvment in OSDI Questionnaire score from baseline to 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.

Percentage of subjects with improvement in CLDEQ8 Questionnaire score from baseline to 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

Percentage of subjects with improvement in MGSS from baseline to 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.

Percentage of subjects with improvement in comfortable SCL (soft contact lens) wearing time from baseline to 1 month

Total comfortable soft contact lens wearing time per week will be asked via questionnaire.

Percentage of subjects with dryness symptoms who reported wearing their contact lenses longer, 1 month post treatment.

Total soft contact lens wearing time per week will be asked via questionnaire.

Secondary Outcome Measures

Mean change in Sodium Fluorescein and Lussamine Green staining from baseline to 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.

Mean change in TBUT from baseline to 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.

Full Information

NCT ID

NCT05306561

First Posted

March 23, 2022

Last Updated

March 23, 2022

Sponsor

Periman Eye Institute

Collaborators

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT05306561

Brief Title

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

Official Title

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

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 26, 2022 (Actual)

Primary Completion Date

April 2022 (Anticipated)

Study Completion Date

May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Periman Eye Institute

Collaborators

Alcon Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meibomian Gland Dysfunction, Dry Eye

Keywords

dry eye disease, meibomian gland dysfunction, ilux, thermal pulsation, contact lens

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

Single arm trial

Intervention Type

Procedure

Intervention Name(s)

Systane iLux thermal pulsation treatment

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percentage of subjects with improvment in OSDI Questionnaire score from baseline to 1 month

Description

OSDI (Ocular Surface Disease Index) is a subjective dry eye symptom questionnaire. A lower OSDI score represents less frequent and/or less severe symptoms.

Time Frame

1 month

Title

Percentage of subjects with improvement in CLDEQ8 Questionnaire score from baseline to 1 month

Description

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

Time Frame

1 month

Title

Percentage of subjects with improvement in MGSS from baseline to 1 month

Description

Time Frame

1 month

Title

Percentage of subjects with improvement in comfortable SCL (soft contact lens) wearing time from baseline to 1 month

Description

Total comfortable soft contact lens wearing time per week will be asked via questionnaire.

Time Frame

1 month

Title

Percentage of subjects with dryness symptoms who reported wearing their contact lenses longer, 1 month post treatment.

Description

Total soft contact lens wearing time per week will be asked via questionnaire.

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Mean change in Sodium Fluorescein and Lussamine Green staining from baseline to 1 month

Description

Mean change in ocular surface staining (sodium fluorescein and lissamine green) from baseline as measured by the National Eye Institute and Oxford grading scales.

Time Frame

1 month

Title

Mean change in TBUT from baseline to 1 month

Description

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Eligible subjects must be 18 years of age or older Eligible subjects must be willing and able to provide an English language written Informed Consent Form 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. Have worn the same commercially available soft contact lens (material, base curve, diameter) for the previous 90 days Have new contact lens to wear starting the first day after iLux treatment Have an OSDI score greater than ≥ 12 Have a CLDEQ8 score ≥ 12 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. Be able and willing to follow instructions and participate in all trial assessments and visits Eligible subjects must be fully vaccinated against COVID-19 Exclusion Criteria: Have any clinically significant slit-lamp findings at Visit 1 that in the opinion of the investigator may interfere with trial parameters Have abnormal lid anatomy eg. entropion, ectropion or active lid lesion eg. hordeolum, chalazion that may interfere with administering iLux treatment Had Lipiflow, iLux, Tear Care or manual meibomian gland expression in the last 30 days Be a woman who is pregnant, nursing, or planning a pregnancy Had ocular surgery within the last 90 days Have used topical cyclosporine, lifitegrast, topical or facial steroids, serum tears, or oral doxycycline or tetracycline within the last 30 days before Visit 1 Had Intense Pulsed Light (IPL) treatment within last 30 days Have active ocular infection or inflammation Be a current wearer of extended wear contact lenses

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sathi Maiti, OD

Phone

2063470821

sathi.maiti@gmail.com

Facility Information:

Facility Name

Periman Eye Institute

City

Seattle

State/Province

Washington

ZIP/Postal Code

98119

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sathi Maiti, OD

Phone

206-347-0821

sathi.maiti@gmail.com

First Name & Middle Initial & Last Name & Degree

Christeen Denui

Phone

2063470821

christeen@perimaneyeinstitute.com

First Name & Middle Initial & Last Name & Degree

Laura M Periman, MD

First Name & Middle Initial & Last Name & Degree

Sathi Maiti, OD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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