Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study, sponsored by TearScience.
NCT01521507 is a NA study that has completed, run by TearScience. The registered enrollment target is 200 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To assess the meibomian glands, the secretion characteristics from 15 gland orifices along the lower eyelid were evaluated under a slit lamp biomicrosope using a handheld instrument, Meibomian Gland Evaluator, to apply gentle standardized pressure to the eyelid margin. Expressed secretion characteristics were graded on a scale of 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated/toothpaste consistency), and 0 (no secretion). Total meibomian gland score was calculated based
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 |
What the finished NCT01521507 record still lists
NCT01521507 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which LipiFlow System is the first listed.
NCT01521507 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01521507's enrollment target sits among peer trials
200 506th of 2000 higher than 1,434 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00107289 · 200 participants · Phase 2
Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma
- NCT00109174 · 200 participants · NA
MRS Measurement of Glutamate and GABA Metabolism in Brain
- NCT00177268 · 200 participants
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
- NCT00493688 · 200 participants
A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia