Clinical trial NCT05306561: Evaluating Impact of Systane iLux on Dryness Symptoms and Wearing Time in Contact Lens Users
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Meibomian Gland Dysfunction
Dry Eye
Keywords: dry eye disease
meibomian gland dysfunction
ilux
thermal pulsation
contact lens
Lead sponsor: Periman Eye Institute
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2022-04-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 meibomian gland secretion scores.

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 secretion scores, and subjective dry eye symptoms in soft contact lens wearing subjects with meibomian gland dysfunction.

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

Primary outcomes:
measure: Percentage of subjects with improvment in OSDI Questionnaire score from baseline to 1 month
timeFrame: 1 month
measure: Percentage of subjects with improvement in CLDEQ8 Questionnaire score from baseline to 1 month
timeFrame: 1 month
measure: Percentage of subjects with improvement in MGSS from baseline to 1 month
timeFrame: 1 month
measure: Percentage of subjects with improvement in comfortable SCL (soft contact lens) wearing time from baseline to 1 month
timeFrame: 1 month
measure: Percentage of subjects with dryness symptoms who reported wearing their contact lenses longer, 1 month post treatment.
timeFrame: 1 month
Secondary outcomes:
measure: Mean change in Sodium Fluorescein and Lussamine Green staining from baseline to 1 month
timeFrame: 1 month
measure: Mean change in TBUT from baseline to 1 month
timeFrame: 1 month
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Periman Eye Institute
state: Washington
Study officials:
References: