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NCT03956225 · ClinicalTrials.gov registry record · NA
Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction (MGD): A 12-month, Multicenter Study
A NA study of Meibomian Gland Dysfunction and Evaporative Dry Eye Disease, sponsored by Alcon Research.
- Completed
- Registry status
- NA
- Development phase
- 299
- Enrollment target
- 15
- Study locations
NCT03956225: Completed NA study of Meibomian Gland Dysfunction and Evaporative Dry Eye Disease, sponsored by Alcon Research.
NCT03956225 is a NA study of Meibomian Gland Dysfunction and Evaporative Dry Eye Disease that has completed, run by Alcon Research. The registered enrollment target is 299 participants, above the 65-participant average among 8 other Meibomian Gland Dysfunction trials with a reported enrollment target (360% higher). The trial reports 15 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03956225, a NA study of Meibomian Gland Dysfunction and Evaporative Dry Eye Disease, has completed, sponsored by Alcon Research.
- COMPLETED
- Registry status
- NA
- Development phase
- 299 participants
- Enrollment target
- 15
- Study locations
Study Summary
The purpose of this post-approval study is to demonstrate that iLux treatment offers comparable treatment effectiveness to LipiFlow for MGD treatment at 12 months post single treatment.
Primary Outcome
Meibomian glands on the eyelids were assessed by the examiner using a Meibomian Gland Evaluator and a slit lamp microscope. 5 glands in 3 zones (nasal, medial, temporal) were evaluated for each eye and scored from 0 to 3, with a resultant overall score (MGS) of 0 to 45 for each eye. Scoring was follows: 0 = no secretion (worst), 1 = inspissated, 2 = cloudy, 3 = clear liquid (best). A higher change from baseline score indicates an improvement in meibomian gland function.
Conditions Studied
Interventions
- DEVICE Systane iLux® Dry Eye System
- DEVICE LipiFlow® Thermal Pulsation System
Study Locations (15)
California
- Alcon Investigator 9083 - Long Beach
- Alcon Investigator 9081 - Los Angeles
- Alcon Investigator 9084 - San Diego
Ohio
- Alcon Investigator 8046 - Granville
- Alcon Investigator 6313 - Powell
Florida
- Alcon Investigator 5127 - Panama City
Illinois
- Alcon Investigator 4782 - Highland Park
Kansas
- Alcon Investigator 6567 - Pittsburg
Kentucky
- Alcon Investigator 5582 - Louisville
Minnesota
- Alcon Investigator 6402 - Medina
Missouri
- Alcon Investigator 1455 - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 299 participants |
| Start Date | 2019-06-25 |
| Est. Completion | 2020-10-24 |
| Phase | NA |
What the finished NCT03956225 record still lists
NCT03956225 is an interventional study that assigns participants to a tested intervention. The registered 299 participants enrollment target is mid-sized for trials with a published cap, above the 65-participant average among 8 other Meibomian Gland Dysfunction trials with a reported enrollment target (360% higher).
The record links to 2 conditions, with Meibomian Gland Dysfunction appearing as the primary indexed condition, and to 2 interventions - of which Systane iLux® Dry Eye System is the first listed.
NCT03956225 lists 15 locations in 12 states (California, Ohio, Florida).
Frequently Asked Questions
What is clinical trial NCT03956225 about?
NCT03956225 is a clinical study titled "Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction (MGD): A 12-month, Multicenter Study". The purpose of this post-approval study is to demonstrate that iLux treatment offers comparable treatment effectiveness to LipiFlow for MGD treatment at 12 months post single treatment.
What is the current status of trial NCT03956225?
This trial is currently completed. It is a NA study. The enrollment target is 299 participants. The study started on 2019-06-25. Estimated completion is 2020-10-24.
What conditions does trial NCT03956225 study?
This clinical trial studies the following conditions: Meibomian Gland Dysfunction, Evaporative Dry Eye Disease.
What interventions are being tested in trial NCT03956225?
The interventions under investigation include: Systane iLux® Dry Eye System (DEVICE), LipiFlow® Thermal Pulsation System (DEVICE).
Who is sponsoring clinical trial NCT03956225?
This trial is sponsored by Alcon Research, which has 275 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03956225 being conducted?
This trial has 15 study locations across California, Florida, Illinois, Kansas, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Meibomian Gland Dysfunction
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03956225's enrollment target sits among peer trials
299 1st of 8 higher than 8 of 8 other Meibomian Gland Dysfunction trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Meibomian Gland Dysfunction trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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