Dry Eye Clinical Trial
Official title:
Assessment of Inflammatory and Functional Changes in the Ocular Surface Associated With Dry Eye Disease
This project will examine the similarities and differences of the ocular surface and tear film in patients with Sjogren's syndrome related to dry eye, severe dry eye and those who do not have dry eye. This knowledge will help clinicians understand the processes that create these dry eye conditions and will strengthen the treatment and management strategies that will be used. The subjects will participate in a series of dry eye tests that they have already experienced in clinic, along with the gathering of tear samples and surface cells. These tissues will then be analyzed at a distant site.
Dry eye is a multifactorial disease of the tears and ocular surface that results in symptoms
of discomfort, visual disturbance and tear film instability with potential damage to the
ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation
of the ocular surface. A number of factors have been implicated in triggering this disease,
including age, hormone changes and autoimmune disease.
Sjogren's syndrome(SS) is a common autoimmune disorder, characterized by chronic
inflammatory infiltration of exocrine glands (particularly salivary and lacrimal) and
systemic immune reactivity, resulting in dry eye and dry mouth. The mechanism of
inflammation of the lacrimal gland in these patients is well documented. It is believed that
these pathological changes facilitate the secretion of inflammatory biochemicals on to the
ocular surface. Additionally, in SS, there are also pathological changes to epithelial cells
of the cornea and conjunctiva (such as upregulation of mRNAs coding for inflammatory
cytokines) which subsequently contribute to the increased secretion of the cytokines
themselves. Taken together, these changes result in an increased concentration of
inflammatory mediators in the tear film, which then drive the propagation of the dry eye
disease process. Severe dry eye (DE) patients present with a very similar clinical outcome
to SS patients, however, inflammatory processes associated with either the initiation or
propagation of their dry eye disease has not been well characterized.
This research project was established to quantify similarities and / or differences between
SS and severe dry eye participants, with respect to ocular surface inflammation and
function. Specifically, this study will examine dry eye symptoms, ocular surface integrity
and tear film volume and flow. Additionally, the concentration of inflammatory cytokines
present in the tear film will be quantified.
;
Observational Model: Cohort, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
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 |
NCT06159569 -
Performance and Tolerability of the Medical Device LACRIACT
|
N/A | |
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 | |
Not yet recruiting |
NCT02218827 -
Topical Steroid Treatment For Dry Eye
|
N/A | |
Completed |
NCT02235259 -
Efficacy and Safety of XG-104 for the Treatment of Dry Eye
|
Phase 2 | |
Completed |
NCT01959854 -
Efficacy of Topical 0.2% Xanthan Gum in Patients With Dry Eye
|
N/A |