Dry Eye Clinical Trial
— AST/SSOfficial title:
Autologous Serum Tears Combined With 0.05% Cyclosporin Eye Drop Improve Corneal Nerve Density in Patients With Sjögren's Syndrome Dry Eye
NCT number | NCT06013436 |
Other study ID # | 22LLZX10 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2022 |
Est. completion date | June 1, 2023 |
Verified date | August 2023 |
Source | Chengdu University of Traditional Chinese Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The objective of the present study was to evaluate the efficacy of autologous serum tears combined with 0.05% cyclosporin eye drop in treating Sjögren's syndrome dry eye and their effect on corneal nerves. We assessed the impact of 12-week AST combined with 0.05% cyclosporin eye drop treatment on signs, symptoms, and sub-basal nerve density (SND) in patients with dry eyes related to Sjogren's syndrome.
Status | Completed |
Enrollment | 30 |
Est. completion date | June 1, 2023 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Patients were diagnosed with SS according to the classification criteria defined by the American-European Consensus Group for the diagnosis of SS and also diagnosed with severe DED based on the consensus of Chinese dry eye experts. - Age 18-65 years old. - Controlled collagen disease by the same rheumatologists at least 3 months prior to the initiation of the trial. - At least one eye that failed to respond to previous treatments including lartificial tears, topical ocular NSAIDs or corticosteroids. Exclusion Criteria: - Patients with DED related to meibomian gland dysfunction, blepharitis, abnormal blinking, conjunctival relaxation or any other diseases besides SS. - Diagnosed with allergic conjunctivitis, uveitis, ocular hypertension, retinopathy and other eye diseases. - Those who have a history of previous ocular oprations, eye injuries or contact lenses usage. - Known hypersensitivity to experimental drugs or any of its ingredients. - Necessity to modify the systemic treatment of previous diseases during the trial. - Pregnancy or lactation. - Severe systemic disease. |
Country | Name | City | State |
---|---|---|---|
China | Hospital of Chengdu University of Traditional Chinese Medicine | Chengdu | Sichuan |
Lead Sponsor | Collaborator |
---|---|
Chengdu University of Traditional Chinese Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | cornea nerves | cornea sub-basal nerve density | 12 weeks | |
Primary | cornea staining score | to evaluate corneal epithelial repair(0= no staining; 1= less than 5 staining points; 2= more than 5 and less than 30 staining points within the range of two quadrants; and 3= staining exceeding two quadrants or staining points more than 30) | 4 weeks | |
Secondary | Ocular Surface Disease Index (OSDI) | to assess the quality of life and clinical symptom;The survey generated a score ranging 0-100 (0 indicated absence of eye discomfort and 100 represented maximum eye discomfort) | 4 weeks | |
Secondary | Schirmer's test | to assess tear flow | 4 weeks | |
Secondary | tear film breakup time (TBUT) | to assess tear film stability | 4 weeks |
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 | |
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 |