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

Periman Eye Institute

Status: Enrolling

Conditions: Dry Eye; Meibomian Gland Dysfunction

Treatments: Procedure: Systane iLux thermal pulsation treatment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05306561

PEI-IIT-70111343

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Arm 1

Experimental group

Description:

Single arm trial

Treatment:

Procedure: Systane iLux thermal pulsation treatment