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

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: Recruiting
• Conditions: Dry Eye; Meibomian Gland Dysfunction
• Intervention / Treatment: Procedure: Systane iLux thermal pulsation treatment

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: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sathi Maiti, OD; Phone Number: 2063470821; Email: sathi.maiti@gmail.com

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98119
      • Recruiting
      • Periman Eye Institute
      • Contact: Sathi Maiti, OD; Phone Number: 206-347-0821; Email: sathi.maiti@gmail.com
      • Contact: Christeen Denui; Phone Number: 2063470821; Email: christeen@perimaneyeinstitute.com
      • Principal Investigator: Laura M Periman, MD
      • Sub-Investigator: Sathi Maiti, OD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
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.	1 month
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	1 month
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.	1 month
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.	1 month
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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month
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.	1 month

Collaborators and Investigators

• Sponsor: Periman Eye Institute
• Collaborators: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: March 23, 2022
• First Submitted That Met QC Criteria: March 23, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: contact lens; meibomian gland dysfunction; dry eye disease; ilux; thermal pulsation
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eyelid Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Meibomian Gland Dysfunction
• Other Study ID 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