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

Autologous Serum Tears Combined With 0.05% Cyclosporin Eye Drop Improve Corneal Nerve Density in Patients With Sjögren's Syndrome Dry Eye

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye; Sjogren's Syndrome; Ocular Surface Disease
• Intervention / Treatment: Drug: Autologous serum tears combined with 0.05% cyclosporin eye drop

Detailed Description

Objective: To describe the clinical efficacy and safety of the treatment of Sjögren's syndrome dry eye using autologous serum tears combined with 0.05% cyclosporin eye drop and to evaluate their effect on corneal nerves.

Design: Singal-center, prospective, observational study. Patients and methods: Thirty eyes of fifteen patients with dry eye related to Sjögren syndrome were enrolled in this study. Following a 4-week washout period, the treatment was inverted for each patient for the same duration and treatment. Ocular Surface Disease Index (OSDI), tear film, break-up time, corneal staining with the use of fluorescein, Schirmer's test and corneal confocal microscopy were investigated.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Hospital of Chengdu University of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.; Other Names: Ciclosporin Eye Drops(II)（Cyclone® ，SHENYANG XINGQI PHARMACEUTICAL Co., Ltd.）

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Schirmer's test	to assess tear flow	4 weeks
tear film breakup time (TBUT)	to assess tear film stability	4 weeks

Collaborators and Investigators

• Sponsor: Chengdu University of Traditional Chinese Medicine
• Investigators: Principal Investigator: Jiachun Hu, Resident, Hospital of Chengdu University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: July 26, 2023
• First Submitted That Met QC Criteria: August 25, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: autologous serum tears; 0.05% cyclosporin eye drop; cornea nerves
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Sjogren's Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Pharmaceutical Solutions; Calcineurin Inhibitors; Ophthalmic Solutions; Cyclosporine; Cyclosporins
• Other Study ID Numbers: 22LLZX10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No