UnknownNot Applicable

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

United States30 participantsStarted 2022-01-26

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. Have any clinically significant slit-lamp findings at Visit 1 that in the opinion of the investigator may interfere with trial parameters

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of subjects with improvment in OSDI Questionnaire score from baseline to 1 month

Timeframe: 1 month

Percentage of subjects with improvement in CLDEQ8 Questionnaire score from baseline to 1 month

Timeframe: 1 month

Percentage of subjects with improvement in MGSS from baseline to 1 month

Timeframe: 1 month

Percentage of subjects with improvement in comfortable SCL (soft contact lens) wearing time from baseline to 1 month

Timeframe: 1 month

Percentage of subjects with dryness symptoms who reported wearing their contact lenses longer, 1 month post treatment.

Timeframe: 1 month

Trial details

NCT IDNCT05306561

SponsorPeriman Eye Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12

Contact for this trial

Sathi Maiti, OD

2063470821 sathi.maiti@gmail.com

View on ClinicalTrials.gov More Meibomian Gland Dysfunction trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. Have any clinically significant slit-lamp findings at Visit 1 that in the opinion of the investigator may interfere with trial parameters

What they're measuring

Percentage of subjects with improvment in OSDI Questionnaire score from baseline to 1 month

Timeframe: 1 month

Percentage of subjects with improvement in CLDEQ8 Questionnaire score from baseline to 1 month

Timeframe: 1 month

Percentage of subjects with improvement in MGSS from baseline to 1 month

Timeframe: 1 month

Percentage of subjects with improvement in comfortable SCL (soft contact lens) wearing time from baseline to 1 month

Timeframe: 1 month

Percentage of subjects with dryness symptoms who reported wearing their contact lenses longer, 1 month post treatment.

Timeframe: 1 month