Trials / Completed
CompletedNCT03956225
Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction (MGD): A 12-month, Multicenter Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 299 (actual)
- Sponsor
- Alcon Research · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Subjects will be expected to attend a total of 8 study visits, including Screening/Baseline, Treatment, and follow-up visits at Week 2 and Months 1, 3, 6, 9, and 12.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Systane iLux® Dry Eye System | Commercially available medical device intended for use by qualified eye care professionals to apply localized heat and pressure therapy to a patient's eyelids. |
| DEVICE | LipiFlow® Thermal Pulsation System | Commercially available medical device intended for use by qualified eye care professionals to apply localized heat and pressure therapy to a patient's eyelids. |
Timeline
- Start date
- 2019-06-25
- Primary completion
- 2020-10-24
- Completion
- 2020-10-24
- First posted
- 2019-05-20
- Last updated
- 2021-10-08
- Results posted
- 2021-10-08
Locations
15 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03956225. Inclusion in this directory is not an endorsement.