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

NCT05306561 | Unknown DMC FDA Device

• 1 other identifier: PEI-IIT-70111343
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Meibomian Gland Dysfunction; Dry Eye

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

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

  1 month

• Mean change in TBUT from baseline to 1 month

  1 month

Study Arms (1)

Arm 1

EXPERIMENTAL

Single arm trial

Procedure: Systane iLux thermal pulsation treatment

Interventions

Systane iLux thermal pulsation treatment PROCEDURE

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.

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Periman Eye Institute: lead
• Alcon Research: collaborator

Study Sites (1)

Periman Eye Institute

Seattle, Washington, 98119, United States

RECRUITING

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Central Study Contacts

Sathi Maiti, OD

CONTACT

2063470821; sathi.maiti@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 1, 2022
• Study Start: January 26, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)