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

Dry Eye Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05306561
• Other study ID #: PEI-IIT-70111343
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2022
• Est. completion date: December 2023

Study information

• Verified date: November 2023
• Source: Periman Eye Institute
• Contact: Sathi Maiti, OD
• Phone: 2063470821
• Email: sathi.maiti[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Meibomian Gland Dysfunction

Intervention

Procedure:
• Systane iLux thermal pulsation treatment
Systane iLux thermal pulsation uses light emitting diode (LED) technology to emit light that is absorbed by pigments (melanin and hemoglobin) in the eyelid. The pigments convert the light energy to heat, which is then transferred to the surrounding tissues, including the meibomian glands. The device heats the eyelid to 40-42°C and maintains it above 40°C during the heating period, which can be 40 seconds or more. This helps melt the meibum. After the heating phase, the meibomian glands are expressed with the built in expression system.

Locations

Country	Name	City	State
United States	Periman Eye Institute	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Periman Eye Institute	Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with improvment in OSDI Questionnaire score from baseline to 1 month	OSDI (Ocular Surface Disease Index) is a subjective dry eye symptom questionnaire. A lower OSDI score represents less frequent and/or less severe symptoms.	1 month
Primary	Percentage of subjects with improvement in CLDEQ8 Questionnaire score from baseline to 1 month	CLDEQ8 (Contact Lens Dry Eye Questionnaire) is a subjective contact lens discomfort and dryness questionnaire. A lower CLDEQ8 score represents less frequent and/or less severe symptoms	1 month
Primary	Percentage of subjects with improvement in MGSS from baseline to 1 month	MGSS (Meibomian gland secretion score). To determine the meibomian gland score, secretion characteristics of 15 meibomian glands along the lower eyelid were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/ toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range between 0 and 45. A higher score reflects less meibomian gland dysfunction.	1 month
Primary	Percentage of subjects with improvement in comfortable SCL (soft contact lens) wearing time from baseline to 1 month	Total comfortable soft contact lens wearing time per week will be asked via questionnaire.	1 month
Primary	Percentage of subjects with dryness symptoms who reported wearing their contact lenses longer, 1 month post treatment.	Total soft contact lens wearing time per week will be asked via questionnaire.	1 month
Secondary	Mean change in Sodium Fluorescein and Lussamine Green staining from baseline to 1 month	Mean change in ocular surface staining (sodium fluorescein and lissamine green) from baseline as measured by the National Eye Institute and Oxford grading scales.	1 month
Secondary	Mean change in TBUT from baseline to 1 month	The investigator instilled sodium fluorescein into the lower eyelid and asked the patient to blink several times, then stop. The time between the last blink and the first appearance of a dark spot on the cornea (formation of a dry area) on the otherwise continuously stained tear film was recorded in seconds. 3 consecutive measurements were taken, with TBUT defined as the average of the 3 measurements. A positive change value represents A positive change value represents a more stable tear film (improvement). Eyes were assessed individually.	1 month