An interventional study of Systane iLux thermal pulsation treatment in Meibomian Gland Dysfunction and Dry Eye, sponsored by Periman Eye Institute. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Periman Eye Institute · Not applicable, Interventional, and Treatment
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.
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.
170 studies on the registry are indexed under Meibomian Gland Dysfunction; 20 are open to participants now.
This study's planned enrollment of 30 is below the median of 49 across 141 interventional studies indexed under Meibomian Gland Dysfunction.
Browse Meibomian Gland Dysfunction studies →This is the only study on the registry with Periman Eye Institute as lead sponsor.
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Exclusion Criteria:
Single arm trial
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.
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.
Time frame: 1 month
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
Time frame: 1 month
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.
Time frame: 1 month
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.
Time frame: 1 month
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.
Time frame: 1 month
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.
Time frame: 1 month
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.
Time frame: 1 month
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2022 (actual). Primary completion is estimated for Dec 2023, 23 months after the start.
Of 50 non-industry interventional studies with no phase under Meibomian Gland Dysfunction, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's planned 23 months is above that.
Counting every sponsor, half of 73 studies reached it within 10 months; a quarter within 4 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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