Evaluating the effect of Systane iLux on dry eye symptoms in contact lens users
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
This study is testing if a new treatment can help contact lens wearers with dry eyes feel more comfortable and wear their lenses longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Periman Eye Institute Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT05306561 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the impact of a single treatment with the Systane iLux thermal pulsation device on dryness symptoms and contact lens wearing time in individuals suffering from meibomian gland dysfunction. Participants will undergo a single treatment and will be evaluated for changes in their dry eye symptoms using OSDI scores, subjective questionnaires, and meibomian gland secretion scores. The study is designed as a single-arm, single-center intervention, focusing on soft contact lens wearers who experience discomfort. The goal is to determine the effectiveness of this treatment in improving comfort and wear time for contact lens users.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are current soft contact lens wearers experiencing discomfort that limits their wearing time.
Not a fit: Patients who do not wear soft contact lenses or have mild dry eye symptoms may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance the comfort and wear time of contact lenses for patients suffering from dry eye symptoms.
How similar studies have performed: Previous studies have shown promising results with thermal pulsation treatments for meibomian gland dysfunction, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seattle, Washington
- Periman Eye Institute — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Sathi Maiti, OD
- Email: sathi.maiti@gmail.com
- Phone: 2063470821
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.