Dry Eye Clinical Trial
Official title:
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) 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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06159569 -
Performance and Tolerability of the Medical Device LACRIACT
|
N/A | |
| Completed |
NCT05027087 -
The Effect of a Novel Blueberry Supplement on Dry Eye Disease
|
Phase 3 | |
| Completed |
NCT05102409 -
An Exploratory Clinical Trial to Assess Safety and Tolerability in Subjects With Dry Eye Disease
|
Phase 2 | |
| Completed |
NCT04081610 -
Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution
|
Phase 1 | |
| Completed |
NCT05062564 -
Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye
|
N/A | |
| Completed |
NCT05825599 -
PMCF Study to Evaluate Performance and Safety of "HPMC-based Eyedrops" Used to Relieve Dry Eye Symptoms
|
N/A | |
| Completed |
NCT03418727 -
Dry Eye Disease Study With Brimonidine
|
Phase 2 | |
| Active, not recruiting |
NCT04425551 -
Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction
|
N/A | |
| Recruiting |
NCT04527887 -
Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED)
|
Phase 4 | |
| Not yet recruiting |
NCT06379685 -
Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface.
|
Phase 1 | |
| Active, not recruiting |
NCT05618730 -
Safety, Tolerability, Plug Retention and Preliminary Efficacy of Tacrolimus-loaded Punctal Plug in Patients With Moderate to Severe Dry Eye Disease - Cohort B
|
Phase 1 | |
| Completed |
NCT04553432 -
Dry Eye OmniLenz Application of Omnigen Research Study
|
Phase 4 | |
| Recruiting |
NCT04109170 -
Dry Eye Evaluation System Based on Bioinformatics
|
||
| Completed |
NCT04105842 -
Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type
|
N/A | |
| Completed |
NCT05505292 -
Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers
|
Phase 4 | |
| Completed |
NCT04668131 -
Study on Curative Effect and Mechanism of Acupuncture on Neuropathic Pain in Dry Eye Disease
|
N/A | |
| Completed |
NCT06176651 -
Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers
|
Phase 4 | |
| Completed |
NCT02235259 -
Efficacy and Safety of XG-104 for the Treatment of Dry Eye
|
Phase 2 | |
| Not yet recruiting |
NCT02218827 -
Topical Steroid Treatment For Dry Eye
|
N/A | |
| Completed |
NCT01959854 -
Efficacy of Topical 0.2% Xanthan Gum in Patients With Dry Eye
|
N/A |