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A randomized, open-label, parallel, self-controlled clinical trial of GeneIII® L-Ergothioneine Capsules eyewash for the improvement of ocular discomfort

A randomized, open-label, parallel, self-controlled clinical trial of GeneIII® L-Ergothioneine Capsules eyewash for the improvement of ocular discomfort

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090987
Enrollment
Unknown
Registered
2024-10-17
Start date
2024-11-04
Completion date
Unknown
Last updated
2026-08-24

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

Conditions

Dry eyes, itching, redness, foreign body sensation, burning sensation, photophobia, tearing in windy conditions, soreness, fatigue, long-term use of beauty contact lenses or contact lenses, and prolonged exposure to electronic devices

Interventions

Trial group 1:Employ GeneIII L-Ergothioneine Capsules sulfate eye wash - 1 (5 milliliters) for a duration of two weeks.
Trial group 2:Employ ergothioneine sulfate eye wash - 1 (0.5 milliliters) for a duration of two weeks.

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 an informed consent form before screening, fully understand the content and process of the trial and the possible adverse reactions, and be able to complete the study according to the trial protocol requirements; 2. Male and non-pregnant, non-lactating female subjects aged 18 to 70 years (including boundary values); 3. At the time of screening, the main complaint should be one of the following subjective symptoms: dry eyes, foreign body sensation, burning sensation, fatigue, discomfort, red eyes, or fluctuation of vision, with a Chinese Dry Eye Questionnaire score of >=7 points; 4. Subjects (including male subjects) are willing to have no fertility plans from the time of screening until one month after the last use of the study product, and voluntarily take two effective non-drug contraceptive measures (see appendix), and have no plans to donate sperm or eggs.

Exclusion criteria

Exclusion criteria: 1. Individuals with contraindications or allergies to trial products or diagnostic reagents; 2. At the screening period, any active infection, ocular inflammation, or allergy in either eye, including but not limited to active blepharitis, active ocular allergies, or meibomian gland dysfunction requiring treatment; 3. Individuals with a history of ocular herpes or those currently undergoing long-term oral antiviral medication for herpes-related diseases; 4. Absence of congenital lacrimal glands or meibomian glands in the eye; 5. Significant conjunctival scarring as judged by the investigator in the study eye; 6. Severe/serious ocular diseases, severe/serious systemic diseases, or uncontrolled medical conditions that may confound study assessments or limit compliance, as judged by the investigator; 7. Individuals who have undergone incisional ocular surface surgery within the last month, including but not limited to corneal refractive surgery, LASIK, pterygium surgery, etc.; 8. Subjects who have used other investigational drugs or devices in another clinical trial within the last 3 months; 9. Women who are pregnant, lactating, have a positive pregnancy test result, or are planning to become pregnant; 10. Subjects whom the investigator deems unsuitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
China Dry Eye Questionnaire (CDEQ) ;Ocular Surface Disease Index (OSDI); Asthenopia Survey Questionnaire for General Surveys (ASQ-11);Non-invasive Breakup Time (NIBUT) ;Corneal Fluorescein Staining;

Countries

China

Contacts

Public ContactJiang Jiang

The First People's Hospital of Hefei

76535325@qq.com+86 551 8213 8060

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 19, 2026