Using Dry Eye As a Disease Model, Investigators Demonstrated the Optimal Selection of Individualized Clinical Interventions and the Superiority of Dynamic Treatment Discrimination in Chinese Medicine. (DED OSDI FBUT)

Demonstration Clinical Study of Dry Eye Disease Advantage

In this study, dry eye disease (leukoaraiosis) is used as a model disease, and the methodological system for evaluating the clinical efficacy of Chinese medicine for dry eye disease is constructed with the core of "subgrouping dynamic and static parallel group design", so as to carry out a real-world demonstration study of dry eye disease as a dominant disease in Chinese medicine treatment. The purpose of this study is to demonstrate the selection of individualized clinical interventions and the superiority of dynamic diagnosis and treatment using dry eye as a disease model. The study provides a clinical example of a subgroup-based dynamic and static parallel group design for TCM clinical research on "disease-based integrated treatment". Based on the conclusions of the efficacy evaluation study, investigators will provide real-world clinical data of dry eye syndrome for the artificial intelligence prediction of the integrated platform of individualized clinical evaluation and evidence support of Chinese medicine with multi-source data integration.

Study Overview

• Status: Not yet recruiting
• Conditions: Dry Eye Disease (DED)
• Intervention / Treatment: Combination product: fumigation with Chinese medicine; Drug: Oral herbal medicine; Drug: Modern Western Medicine

• Study Type: Interventional
• Enrollment (Estimated): 4000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lu; Phone Number: 18908178510; Email: luxuejing@cdutcm.edu.cn

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Be 18-75 years of age and of any gender
• Meets Western diagnostic criteria for dry eye
• Formed consent and signed the Informed Consent Form

Exclusion Criteria:

• Those who are unable to perform a dry eye examination due to various factors
• Patients with severe diseases of the liver or renal system, or infectious eye diseases
• Those who are allergic to the medications used in this study
• Women who are pregnant or breastfeeding Mental illness or intellectual disability; Participants in clinical trials of other drugs within the last 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Chinese Medicine External Treatment Group	Combination product: fumigation with Chinese medicine; Eye fumigation with the Eyesight Eye Therapy,10 minutes once daily for 6 weeks.
Experimental: Chinese Medicine Internal Treatment Group (Oral Herbal Medicine)	Drug: Oral herbal medicine; Patients were identified into the appropriate group according to the individual evidence profile, and the herbal formula under the corresponding evidence profile was taken orally as one dose of 150 ml of water twice a day for 6 weeks.
Active Comparator: Western medicine treatment group	Drug: Modern Western Medicine; Referring to the Chinese Expert Consensus on Dry Eye: Treatment (2020), this course of treatment totaled 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chinese Medical Evidence Scale	The TCM evidence scale converts symptoms and signs into TCM evidence, and assigns 1, 2, and 3 points according to three levels of severity, with reference to the "Guiding Principles for Clinical Research on New Drugs of Traditional Chinese Medicine" and the "International TCM Clinical Practice Guidelines for Stemmed Eyes (2021-12-14)". If the points of TCM evidence are higher or unchanged after the intervention, it means that the intervention measures are ineffective or inefficient, and that patients' clinical symptoms do not improve significantly or their conditions worsen after the treatment. If the TCM syndrome score increases or remains unchanged after the intervention compared with that before treatment, it means that the intervention is ineffective or inefficient, and the patient's clinical symptoms do not improve or worsen after treatment.	From enrollment to end of 6-week treatment
Ocular Surface Disease Index	By evaluating the points before and after the intervention treatment, if the points are lower than before the treatment, it suggests that the intervention treatment is effective, on the contrary, it indicates that the intervention is ineffective or ineffective, and the clinical symptoms of the patients do not improve significantly or worsen after the treatment.	From enrollment to end of 6-week treatment
Fluorescein Breakup Time	Efficacy was evaluated by the values tested before and after the intervention	From enrollment to end of 6-week treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Schirmer Ⅰ test	Efficacy was evaluated by the values tested before and after the intervention	From enrollment to end of 6-week treatment
Height of the River of Tears	Efficacy was evaluated by the values tested before and after the intervention	From enrollment to end of 6-week treatment
fluorescent staining of the cornea	See the Chinese Expert Consensus on Dry Eye: Expert Consensus on Definition and Classification (2020): the cornea was divided into 4 quadrants on average, and each quadrant was scored from 0 to 3 according to the staining of sodium fluorescein, with a score of 0: no staining; 1: 1-30 punctate staining; 2: >30 punctate staining but staining not fused; and 3: fusion of the corneal punctate staining with the appearance of filaments and ulcers, etc. The final tally scores for each quadrant were summed. The efficacy was evaluated by tallying the scores detected before and after the intervention.	From enrollment to end of 6-week treatment
Classification of blepharoplasty deficiency	The efficacy was evaluated by scoring the blepharoplasty area values detected before and after the intervention. According to the Chinese Expert Consensus on Meibomian Gland Dysfunction (2023), investigators graded the results as follows: score 0: no meibomian gland deficiency; score 1: meibomian gland deficiency ratio <1/3; score 2: meibomian gland deficiency ratio 1/3-2/3; and score 3: meibomian gland deficiency ratio >2/3.	From enrollment to end of 6-week treatment

Collaborators and Investigators

• Sponsor: Xuejing Lu

Study record dates

Study Major Dates

• Study Start (Estimated): September 25, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 20, 2024

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: September 21, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: 2024YH008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No