Efficacy and safety of Pearl Mingmu eye drops (colloidal solution) in the treatment of patients with visual fatigue

Phase 4

• Conditions: Visual fatigue

• Registration Number: ITMCTR2100005227
• Lead Sponsor: anjing Hospital of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1 Patients aged 18 and over, male or female;
2.According to the consensus of experts on diagnosis and treatment of visual fatigue (2014), it is diagnosed as mild visual fatigue, that is, the following eye symptoms often occur after eye use:
(1)Visual impairment: short distance work or reading is not lasting, and temporary visual blur or ghosting occurs;
(2)Eye discomfort: eye swelling, eye pain, dry eyes, burning eyes, tears, itching eyes, foreign body in eyes and eye irritation, and orbital pain;
3.BUT<=10s or Schirmer I test (without surface anesthesia) <=10mm/5min;
4.0 < corneal fluorescein staining (CFS) <= 5 points;
5.Patients who are fully informed and willing to sign informed consent and complete the visit.

Exclusion Criteria

1.Patients whose eyes are legally blind;
2.Patients who used pearl eye drops (colloidal solution) or other drugs to relieve visual fatigue and treat dry eye within 1 month before enrollment;
3.Patients diagnosed with severe visual fatigue: there are systemic symptoms, such as fatigue, headache, dizziness, memory loss, even nausea and vomiting, anxiety, irritability and other neurological symptoms;
4.Visual fatigue caused by diseases or factors other than eyes (such as mental and psychological state, female menstruation and menopause);
5.Patients with a history of allergy to the drugs, excipients or any components of the test (such as pearl liquid, borneol, sodium hyaluronate, ethyl hydroxybenzene and fluorescein) scheduled for use in the study;
6.Patients who need to be treated with ocular or systemic non steroidal anti-inflammatory drugs, glucocorticoids, immunosuppressants, physical therapy or eye surgery that has an impact on the efficacy evaluation within 2 weeks before enrollment or during the trial;
7.Patients who need to wear contact lenses within 2 weeks before enrollment or during the trial;
8.Patients who have received lacrimal dot embolization, lacrimal dot closure and other lacrimal dot closure treatment;
9.Patients with active ocular inflammation requiring treatment;
10.Female patients with planned pregnancy, pregnancy or lactation;
11.Patients who have participated or are participating in other clinical trials within 1 month;
12.Patients with uncontrolled systemic diseases or other reasons that the investigator judges are not suitable for entering this study.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in visual fatigue scale scores from baseline;Changes in corneal fluorescein staining score from baseline;

Secondary Outcome Measures

Name	Time	Method
Patient medication comfort score;Changes in ocular symptoms and daily life questionnaire scores from baseline;Change in tear film rupture time compared to baseline;Changes in Schirmer I test (no surface anesthesia) results from baseline;Incidence of adverse reactions (ocular and systemic);