RECRUITING

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

Conditions

Meibomian Gland Dysfunction Dry Eye dry eye disease ilux thermal pulsation contact lens

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-01-26

Study Completion:2023-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05306561

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Sathi Maiti, OD

CONTACT

2063470821

sathi.maiti@gmail.com

Study Locations (Sites)

Periman Eye Institute

Seattle, Washington, 98119

United States

Collaborators and Investigators

Sponsor: Periman Eye Institute

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 Registration Dates

Study Start Date2022-01-26

Study Completion Date2023-12

Study Record Updates

Study Start Date2022-01-26

Study Completion Date2023-12

Terms related to this study

Keywords Provided by Researchers

dry eye disease
meibomian gland dysfunction
ilux
thermal pulsation
contact lens

Additional Relevant MeSH Terms

Meibomian Gland Dysfunction
Dry Eye