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

Status unconfirmed · Not applicable

Conditions studied: Meibomian Gland Dysfunction, Dry Eye

In brief

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.

Key facts

Study ID: NCT05306561
Run by: Periman Eye Institute
People needed: 30
Starts: 2022-01-26
Expected to finish: 2023-12-01
Last updated by the study team: 2023-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

Periman Eye Institute — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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