Dry Eye Clinical Trial
Official title:
Pilot Study to Examine Efficacy and Cytokines Levels After Meibomian Gland Expression (MGX) With and Without Intense Pulsed Light Treatment (IPL)
Dry eye disease (DED) is a common condition that causes ocular discomfort and reduces visual
acuity. The two categories of DED are evaporative dry eye and aqueous deficient dry eye. Both
conditions can involve pathology of the meibomian glands, lacrimal glands, lids, tear film
and surface cells. Meibomian gland dysfunction (MGD) is the leading cause of evaporative dry
eye and contributes to aqueous deficient dry eye. The goal of MGD therapy is to provide long
term improvement of symptoms for patients by improving the quality of meibum, increasing
meibum flow, improving tear film stability and decreasing inflammation.
Commonly used therapies include preservative free drops, omega-3 fatty acid supplementation,
topical cyclosporine, serum tears, topical azithromycin, oral doxycycline, moisture chambers,
intraductal probing, lib margin exfoliation, automated thermal pulsation, warm compresses,
among other. Despite this variety of symptoms, patients often do not experience complete or
long term relief of symptoms.
Forced meibomian gland expression (MGX) has been shown to be an effective method of
rehabilitating meibomian glands and improving dry eye symptoms. The eyelid margins are
forcefully compressed to express gland contents. Research has shown improvement in patient
symptoms with the use of MGX.
Intense pulsed light (IPL) have been used in dermatology to treat various conditions.
Patients with DED who have tried other therapies and found no relief, often resort to IPL as
a last resort. Research has shown IPL alone may be effective in improving patient symptoms.
In addition, such studies have failed to show significant adverse events with the use of IPL.
Here, we propose a prospective, randomized, case controlled clinical pilot study to examine
the efficacy for both subjective and objective measures. 20 patients with DED will be
recruited and will be randomly assigned to one of two groups: MGX alone or MGX with IPL.
Objective measures will include tear cytokine levels, impression cytology, meibography, tear
osmolarity and others. Subjective measures will include quality of life screening tools.
We hypothesize that the use of MGX with IPL will lead to greater improvement in subjective
dry eye symptoms and objective measures. Given the lack of adverse effects reported in the
literature, we do not anticipate adverse effects in our study.
Rochester staff Drs. Faustch and Bourne are providing clinical research advice but have no
contact with subjects or biospecimens.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05102409 -
An Exploratory Clinical Trial to Assess Safety and Tolerability in Subjects With Dry Eye Disease
|
Phase 2 | |
| 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 |
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 |