Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction (NCT03055832) | Clinical Trial Compass
CompletedNot Applicable
Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction
United States142 participantsStarted 2017-02-09
Plain-language summary
The purpose of this study was to compare changes in meibomian gland dysfunction (MGD), tear break-up time (TBT) and evaporative dry eye (EDE) symptoms after treatment with either the iLux® 2020 System or the LipiFlow® Thermal Pulsation System.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age 18 years and older of any gender or race
* Written informed consent to participate in the study
* Willingness and ability to return for all study visits
* Positive history of self-reported dry eye symptoms for three months prior to the study using OSDI with a score of ≥ 23 at the baseline visit
* Evidence of meibomian gland (MG) obstruction, based on total MGS of ≤12 in lower eyelids for each eye as assessed by a clinician not involved in the study procedure
* Tear break-up time \<10 seconds
* Agreement/ability to abstain from dry eye/MGD medications for the time between the screening visit and the final study visit (ocular lubricants are allowed if no changes are made during the study)
Exclusion Criteria:
* History of ocular or corneal surgery including intraocular, oculo-plastic, corneal or refractive surgery within 1 year
* Subjects with giant papillary conjunctivitis
* Subject with punctal plugs or who have had punctal cautery
* Ocular injury or trauma, chemical burns, or limbal stem cell deficiency within 3 months of the baseline examination
* Active ocular herpes zoster or simplex of eye or eyelid or a history of these within the last 3 months
* Subjects who are aphakic
* Cicatricial lid margin disease identified via slit lamp examination, including pemphigoid, symblepharon, etc.
* Active ocular infection
* Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months
* Ocular surface abnormality that …
What they're measuring
1
Change From Baseline to Week 4 in Meibomian Gland Score (MGS)
Timeframe: Baseline, Week 4
2
Change From Baseline to Week 4 in Tear Break-Up Time (TBT)
Timeframe: Baseline, Week 4
3
Incidence (Number) of Device- or Procedure-related Adverse Events