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

Launched by PERIMAN EYE INSTITUTE · Mar 23, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called iLux on people who wear contact lenses and experience dry eye symptoms. Specifically, the trial aims to see if a single treatment with iLux can help improve comfort and increase the amount of time participants can wear their contact lenses without discomfort. Researchers will measure changes in dry eye symptoms and contact lens comfort using questionnaires and scores that assess the health of the glands in the eyelids.

To participate in this study, individuals must be at least 18 years old, currently wear soft contact lenses for several hours a day, and experience discomfort that limits their wear time. Participants should have been using the same type of contact lenses for the last three months and will need to start using new lenses following the iLux treatment. Additionally, they must be fully vaccinated against COVID-19 and able to attend all required visits. If eligible, participants can expect to receive the treatment and complete assessments to help understand how well it works for relieving dry eye symptoms.

Gender

ALL

Eligibility criteria

• 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