AST Combined With 0.05% Cyclosporin Eye Drop Improve Corneal Nerve Density in Patients With SS Dry Eye

NCT06013436 | Completed

• 1 other identifier: 22LLZX10
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sjogren's Syndrome; Dry Eye; Ocular Surface Disease

Keywords

autologous serum tears; 0.05% cyclosporin eye drop; cornea nerves

Outcome Measures

Primary Outcomes (2)

• cornea nerves

  cornea sub-basal nerve density

  12 weeks

• 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 Outcomes (3)

• Ocular Surface Disease Index (OSDI)

  4 weeks

• Schirmer's test

  4 weeks

• tear film breakup time (TBUT)

  4 weeks

Study Arms (1)

Experimental group

Autologous serum tears, twelve times daily（per hour）, 12weeks. 0.05% cyclosporin eye drop, twice times daily, 12weeks.

Drug: Autologous serum tears combined with 0.05% cyclosporin eye drop

Interventions

Autologous serum tears combined with 0.05% cyclosporin eye drop DRUG

All patients administrated autologous serum tears twelve times daily（per hour） and 0.05% cyclosporin eye drop twice times daily in each eye for 12 weeks.

Also known as: Ciclosporin Eye Drops(II)（Cyclone® ，SHENYANG XINGQI PHARMACEUTICAL Co., Ltd.）

Experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

From June 2022 to June 2023, moderate and severe dry eye patients with Sjogren's syndrome were treated in the Department of Ophthalmology and Rheumatology and Immunology of the Hospital of Chengdu University of Traditional Chinese Medicine.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead

Study Sites (1)

Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 610072, China

Location

MeSH Terms

Conditions

Sjogren's Syndrome; Dry Eye Syndromes

Interventions

Long-Term Synaptic Depression

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jiachun Hu, Resident

  Chengdu University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physician

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 28, 2023
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 28, 2023

Record last verified: 2023-08

Locations

CN (1)