Microvascular and Inflammatory Responses of 0.05 Cyclosporine Eye Drop (II) in Treatment of Dry Eye

NCT05131152 | Unknown DMC

• 1 other identifier: 2021KYPJ186
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the law of changes in ocular surface inflammation when 0.05% cyclosporine eye drops (II) is used to treat dry eye, 50 cases of mild to moderate dry eyes were included. The expectation is finding out whether cyclosporine has a regulatory effect on conjunctival microvascular parameters and other inflammation indicators after cyclosporine eye drops treat dry eye, and analyze the value of conjunctival microvascular indicators in dry eye immunosuppressive therapy.

Conditions

Dry Eye

Keywords

dry eye; conjunctival micro-circulation; inflammation

Outcome Measures

Primary Outcomes (1)

• Conjunctival microvascular blood flow velocity

  Achieved by Functional slit lamp Biomicroscopy: a traditional slit lamp (HAAG-STREIT SWISS MADE 900.7.2.34925) with a digital. camera (Canon 60D. Canon Inc, Melville, NY) and a custom software.

  12 weeks after commencement of treatment-16 weeks after commencement of treatment

Secondary Outcomes (1)

• Tear collection and analysis

  12 weeks after commencement of treatment-16 weeks after commencement of treatment

Other Outcomes (11)

• Conjunctival microvascular blood flow

  12 weeks after commencement of treatment-16 weeks after commencement of treatment

• Df (vascular complexity index)

  12 weeks after commencement of treatment-16 weeks after commencement of treatment

• D0 (vascular density index)

  12 weeks after commencement of treatment-16 weeks after commencement of treatment

Study Arms (2)

cyclosporine group

EXPERIMENTAL

Mild DE patients: topical usage of 0.05% cyclosporine Eye Drops BID + 0.1% Sodium Hyaluronate Eye Drops QID, both use for 16 weeks. Moderate DE patients: topical usage of 0.05% cyclosporine Eye Drops BID +0.1% Sodium Hyaluronate Eye Drops QID, both use for 16 weeks, and 0.02% Fluoromethalone Eye Drops BID for 4 weeks.

Drug: Cyclosporine; Device: oculus keratograph, in vivo laser confocal microscopy, Functional slit lamp biomicroscopy

control group

EXPERIMENTAL

Mild DE patients: 0.1% Sodium Hyaluronate Eye Drops QID for 16 weeks Moderate DE patients: 0.02% Fluoromethalone Eye Drops BID for 4 weeks +0.1% Sodium Hyaluronate Eye Drops QID for 16 weeks.

Device: oculus keratograph, in vivo laser confocal microscopy, Functional slit lamp biomicroscopy

Interventions

Cyclosporine DRUG

0.05% cyclosporine Eye Drops; Sodium Hyaluronate Eye Drops, 0.02% Fluoromethalone Eye Drops.

cyclosporine group

oculus keratograph, in vivo laser confocal microscopy, Functional slit lamp biomicroscopy DEVICE

oculus keratograph, in vivo laser confocal microscopy, Functional slit lamp biomicroscopy

control group; cyclosporine group

Eligibility Criteria

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

You may qualify if:

• years old;
• meet the 2-3 grade dry eye diagnosis: 1) At least one eye has one or more ocular discomfort symptoms and OSDI score ≥23; 2) At least one eye meets one of the following two: 2 mm/5min≤Schirmer I test (no anesthesia) \<10 mm/5min; BUT≤10s. 3) Corneal spotting but no extensive erosion.

You may not qualify if:

• Contact lens wearers;
• Allergies to the study drug;
• Active eye infections; history of serious systemic diseases;
• Pregnancy or breastfeeding;
• Receiving or starting other treatments that may interfere with the interpretation of the results;
• Participating any other clinical trials within 3 months;
• Previous eye surgery, including laser treatment and refractive surgery;
• Need or have undergone punctal embolization or nasolacrimal duct obstruction;
• KCS secondary to the destruction of conjunctival goblet cells (such as vitamin A deficiency) ;
• Scar formation (such as cicatricial pemphigus, alkali burn, trachoma or radiation).

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes; Inflammation

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Yuqing Deng, MD

CONTACT

18120557291; 15927646647@163.com

Jin Yuan, PHD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The recruitment of subjects must meet the diagnosis criteria of DEWS.

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 23, 2021
• Study Start: December 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: May 1, 2024
• Last Updated: February 11, 2022

Record last verified: 2022-02

Locations

CN (1)