Ocular Discomfort Induced by Frequent Cosmetic Application or Contact Lens Wear
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Characteristics of eye secretions;Ocular Surface Disease Index;Eye wash liquid properties;Slit-lamp examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tear pH value;Schirmer I Test;Opening status of meibomian gland;Corneal fluorescein staining;Safety/Tolerance; | — |
Countries
China
Contacts
The First People's Hospital of Hefei