Status:
UNKNOWN
Evaluating Impact of Systane iLux on Dryness Symptoms and Wearing Time in Contact Lens Users
Lead Sponsor:
Periman Eye Institute
Collaborating Sponsors:
Alcon Research
Conditions:
Meibomian Gland Dysfunction
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
NA
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 m...
Detailed Description
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 se...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05306561
Start Date
January 26 2022
End Date
December 1 2023
Last Update
November 18 2023
Active Locations (1)
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1
Periman Eye Institute
Seattle, Washington, United States, 98119