N/A
N=142
Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction
Meibomian Gland Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT03055832 ↗Enrolled (actual)
142
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Change From Baseline to Week 4 in Meibomian Gland Score (MGS) — 17.3; 18.0; 17.7; 18.1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- iLux 2020 System (Device); LipiFlow Pulsation System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tear Film Innovations, Inc.
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 4 in Meibomian Gland Score (MGS) |
17.3; 18.0; 17.7; 18.1; 16.9; 17.5 | — |
| PRIMARY Change From Baseline to Week 4 in Tear Break-Up Time (TBT) |
2.86; 2.73; 2.79; 2.69; 2.61; 2.65 | — |
| PRIMARY Incidence (Number) of Device- or Procedure-related Adverse Events |
4; 0 | 0.12 |
| SECONDARY Change From Baseline to Week 4 in Ocular Surface Disease Index (OSDI) |
-31.0; -27.3; -30.9; -37.0; -28.0; -24.9 | — |
| SECONDARY Mean Pain Score During Treatment |
34.4; 34.0; 34.2; 30.8; 32.6; 31.7 | — |
| SECONDARY Mean Discomfort Score During Treatment |
56.3; 55.9; 56.1; 52.1; 52.6; 52.3 | — |
| SECONDARY Change From Baseline to Post-Treatment in Ocular Surface Staining |
0.6; 0.6; 0.6; 0.5; 0.4; 0.4 | — |
| SECONDARY Change From Baseline to Post-Treatment in Intraocular Pressure (IOP) |
0.04; -0.07; -0.01; 0.07; -0.04; 0.01 | — |
| SECONDARY Change From Baseline to Post-Treatment in Best Spectacle-Corrected Visual Acuity (BSCVA) |
0.02; 0.05; 0.03; 0.02; 0.02; 0.02 | — |
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.
Eligibility Criteria
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 may compromise corneal integrity
- Lid surface abnormalities that affect lid function in either eye
- Anterior blepharitis (staphylococcal, demodex or seborrheic grade 3 or 4)
- Systemic disease conditions that cause dry eye
- Unwillingness to abstain from systemic medications known to cause dryness for the study duration
- Women who are pregnant, nursing, or not utilizing adequate birth control measures
- Individuals who have either changed the dosing of systemic medications or non-dry eye/MGD ophthalmic medications within the past 30 days prior to screening
- Individuals who are unable or unwilling to remain on a stable dosing regimen for the duration of the study
- Individuals using isotretinoin (Accutane) within 1 year, cyclosporine-A (Restasis) or lifitegrast ophthalmic solution 5% (Xiidra) within 3 months, or any other dry eye or MGD medications within 2 weeks of screening (ocular lubricants are allowed if no changes are made during the study)
- Individuals wearing contact lenses at any time during the prior three months or during the study period
- Eyelid tattoos, including permanent eyeliner makeup
- Individuals that were treated with LipiFlow in either eye in the last 24 months
- Individuals using another ophthalmic investigational device or agent within 30 days of study participation
- Individuals who are unable to complete the required patient questionnaires in English
Data sourced from ClinicalTrials.gov (NCT03055832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.