Evaluating Impact of Systane iLux on Dryness Symptoms and Wearing Time in Contact Lens Users (NCT05306561) | Clinical Trial Compass
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Evaluating Impact of Systane iLux on Dryness Symptoms and Wearing Time in Contact Lens Users
United States30 participantsStarted 2022-01-26
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
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
✕
What they're measuring
1
Percentage of subjects with improvment in OSDI Questionnaire score from baseline to 1 month
Timeframe: 1 month
2
Percentage of subjects with improvement in CLDEQ8 Questionnaire score from baseline to 1 month
Timeframe: 1 month
3
Percentage of subjects with improvement in MGSS from baseline to 1 month
Timeframe: 1 month
4
Percentage of subjects with improvement in comfortable SCL (soft contact lens) wearing time from baseline to 1 month
Timeframe: 1 month
5
Percentage of subjects with dryness symptoms who reported wearing their contact lenses longer, 1 month post 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