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NCT01521507 · ClinicalTrials.gov registry record · NA
Randomized Controlled Trial of Long-term Treatment Effectiveness for Meibomian Gland Dysfunction (MGD) and Dry Eye
A NA study, sponsored by TearScience.
- Completed
- Registry status
- NA
- Development phase
- 200
- Enrollment target
NCT01521507 is a NA study that has completed, run by TearScience. The registered enrollment target is 200 participants.
The verdict
NCT01521507, a NA study, has completed, sponsored by TearScience.
- COMPLETED
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
Study Summary
The study objective is to evaluate the long-term treatment effectiveness for adult patients with meibomian gland dysfunction (MGD) and evaporative dry eye by: 1) comparing the LipiFlow® System to a standardized daily warm compress and eyelid hygiene control therapy over a duration of 3 Months; and 2) evaluating the LipiFlow® alone and in combination with other MGD and dry eye treatments over a duration of up to 12 Months. This is a post-market, non-significant risk, prospective and multi-center clinical trial divided into two stages. The first stage from enrollment to 3 Months is an open-label, randomized controlled design to compare the effectiveness of a single LipiFlow® System treatment to a standardized daily warm compress and eyelid hygiene Control therapy with Crossover LipiFlow® treatment of the Control subjects at 3 Months. The second stage, occurring between 3 and 12 Months, is an observational design to evaluate the effectiveness of LipiFlow® alone and in combination with other MGD and dry eye treatments over a duration of up to 12 Months. Subjects are entered into the following subgroups based on the subject's self-assessment of the adequacy of symptom relief and protocol-defined criteria for additional treatment. 1. One LipiFlow® Treatment: Subjects who receive only one LipiFlow® treatment. 2. Two LipiFlow® Treatments: Subjects who receive a second LipiFlow® treatment. 3. Combination Treatment: Subjects who receive one or two LipiFlow® treatments followed by other MGD or dry eye treatment, as prescribed by the physician.
Interventions
- DEVICE LipiFlow System
- DEVICE Warm Compress Therapy + Lid Scrub
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2012-01 |
| Est. Completion | 2014-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01521507
The ClinicalTrials.gov registry entry for NCT01521507 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TearScience, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which LipiFlow System is the first listed.
NCT01521507 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01521507 about?
NCT01521507 is a clinical study titled "Randomized Controlled Trial of Long-term Treatment Effectiveness for Meibomian Gland Dysfunction (MGD) and Dry Eye". The study objective is to evaluate the long-term treatment effectiveness for adult patients with meibomian gland dysfunction (MGD) and evaporative dry eye by: 1) comparing the LipiFlow® System to a standardized daily warm compress and eyelid hygiene control therapy over a duration of 3 Months; and 2...
What is the current status of trial NCT01521507?
This trial is currently completed. It is a NA study. The enrollment target is 200 participants. The study started on 2012-01. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01521507?
The interventions under investigation include: LipiFlow System (DEVICE), Warm Compress Therapy + Lid Scrub (DEVICE).
Who is sponsoring clinical trial NCT01521507?
This trial is sponsored by TearScience, which has 6 total clinical trials registered on ClinicalTrials.gov.
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