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NCT Number: NCT06605495

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.

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.

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Key information

Conditions

Dry Eye Disease (DED) Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fumigation with Chinese medicine

Combination Product

Eye fumigation with the Eyesight Eye Therapy,10 minutes once daily for 6 weeks.

Oral herbal medicine

Drug

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.

Modern Western Medicine

Drug

Referring to the Chinese Expert Consensus on Dry Eye: Treatment (2020), this course of treatment totaled 6 weeks.

Primary outcomes

  1. Chinese Medical Evidence Scale

    Time frame: From enrollment to end of 6-week treatment

    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.

  2. Ocular Surface Disease Index

    Time frame: From enrollment to end of 6-week treatment

    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.

  3. Fluorescein Breakup Time

    Time frame: From enrollment to end of 6-week treatment

    Efficacy was evaluated by the values tested before and after the intervention

Secondary outcomes

  1. Schirmer Ⅰ test

    Time frame: From enrollment to end of 6-week treatment

    Efficacy was evaluated by the values tested before and after the intervention

  2. Height of the River of Tears

    Time frame: From enrollment to end of 6-week treatment

    Efficacy was evaluated by the values tested before and after the intervention

  3. fluorescent staining of the cornea

    Time frame: From enrollment to end of 6-week treatment

    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.

  4. Classification of blepharoplasty deficiency

    Time frame: From enrollment to end of 6-week treatment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lu

CONTACT

[email protected]

18908178510

Sponsors and collaborators

Lead sponsor

Xuejing Lu

Other

Registry information

Official study title

Demonstration Clinical Study of Dry Eye Disease Advantage

Acronym: DED OSDI FBUT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 20, 2024
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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