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Efficacy and Safety of Zhen Shi Ming Eye Cleansing Solution for Ocular Surface Hygiene in Frequent Makeup Users or Contact Lens Wearers: An Open-Label Clinical Study

Efficacy and Safety of Zhen Shi Ming Eye Cleansing Solution for Ocular Surface Hygiene in Frequent Makeup Users or Contact Lens Wearers: An Open-Label Clinical Study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099458
Enrollment
Unknown
Registered
2025-03-24
Start date
2025-03-26
Completion date
Unknown
Last updated
2025-03-31

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

Conditions

Ocular Discomfort Induced by Frequent Cosmetic Application or Contact Lens Wear

Interventions

test group:After cleansing the eyes in the morning and evening, use Zhen Shi Ming eye wash for 21 days

Sponsors

The First People's Hospital of Hefei
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Sign the informed consent form before screening, fully understand the content, process and possible adverse reactions of the test, and be able to complete the study in accordance with the requirements of the test protocol; 2. Male and non-pregnant non-lactating female subjects aged >=18 years old and <=70 years old (including boundary values); 3. People with cosmetic eye disease related symptoms or long-term wear of contact lenses (contact lenses, contact lenses). Specific symptoms include, but are not limited to, eye dryness, foreign body sensation, burning sensation, fatigue, malaise, eye redness, and vision fluctuations; Meibomian gland secretions: cloudy fluid discharge (grade 1, mild abnormality), etc.; 4. Subjects (including male subjects) are willing to have no fertility plan and no sperm donation and egg donation plan within 1 month from screening to the last use of the investigational product; 5. The subject has no planned surgery in the past 2 months.

Exclusion criteria

Exclusion criteria: 1. Those who have contraindications or allergies to test supplies or diagnostic reagents; 2. During the screening period, there is active infection, ocular inflammation or allergy in either eye, including but not limited to active blepharitis, active ocular allergies, meibomian gland dysfunction requiring treatment; 3. Those who have a history of ocular herpes, or are receiving long-term oral antiviral drugs for herpetic diseases; 4. There is a congenital lacrimal gland or complete loss of meibomian gland in the eye; 5. Significant conjunctival scarring in the study eye as judged by the investigator; 6. Severe/severe ocular disease, severe/severe systemic disease, or uncontrolled medical condition that, in the judgment of the investigator, may confound the study assessment or limit compliance; 7. Received ocular surface surgery with incision within 1 month before screening, including but not limited to corneal refractive surgery, LASIK, pterygium surgery, etc.; 8. Subjects who have used other clinical trial drugs or devices within 3 months before screening; 9. Pregnant or lactating females, or subjects with positive pregnancy test results, or planned pregnancy; 10. Subjects who are considered unsuitable by the investigator to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Characteristics of eye secretions;Ocular Surface Disease Index;Eye wash liquid properties;Slit-lamp examination;

Secondary

MeasureTime frame
Tear pH value;Schirmer I Test;Opening status of meibomian gland;Corneal fluorescein staining;Safety/Tolerance;

Countries

China

Contacts

Public ContactJiang Jiang

The First People's Hospital of Hefei

76535325@qq.com+86 138 6671 7249

Outcome results

None listed

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