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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005227
Enrollment
Unknown
Registered
2021-08-25
Start date
2021-09-13
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual fatigue

Interventions

Sponsors

Nanjing Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Changes in visual fatigue scale scores from baseline;Changes in corneal fluorescein staining score from baseline;

Secondary

MeasureTime frame
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);

Countries

China

Contacts

Public ContactFan Yi

Suzhou Industrial Park Tianlong Pharmacy Co., Ltd.

cyc256@163.com+86 512 65937791

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026