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Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction (MGD): A 12-month, Multicenter Study
NCT03956225 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03956225
The ClinicalTrials.gov registry entry for NCT03956225 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 299 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alcon Research, which has 111 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03956225 reports 15 study locations spanning 12 distinct geographic areas — top geographies include California, Ohio, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03956225?
The interventions under investigation include: Systane iLux® Dry Eye System (DEVICE), LipiFlow® Thermal Pulsation System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03956225?
This trial is sponsored by Alcon Research, which has 111 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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