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Exploration of ocular surface microbiota detection for classification diagnosis and monitoring of different drug efficacy in dry eye patients

Exploration of ocular surface microbiota detection for classification diagnosis and monitoring of different drug efficacy in dry eye patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500100341
Enrollment
Unknown
Registered
2025-04-08
Start date
2025-04-30
Completion date
Unknown
Last updated
2025-04-14

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

Conditions

Dry eye disease

Interventions

Diquafosol sodium ophthalmic solution group:None
Cyclosporine eye drop group:None
Control group:None

Sponsors

Eye & ENT Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria for non dry eye participants: Participants must meet both of the following criteria simultaneously: 1. No history of dry eye disease, no subjective symptoms such as dryness, foreign body sensation, burning sensation, fatigue, discomfort, or visual fluctuations; 2. Simultaneously meet TBUT>10 seconds, Schirmer i test>10 mm/5 minutes, and corneal fluorescein staining negative. Inclusion criteria for dry eye patients: a history of DED, at least one subjective symptom such as dryness, foreign body sensation, burning sensation, fatigue, discomfort, or visual fluctuations, and at least one of the following: 1. Tear film rupture time (TBUT) is less than 5 seconds; 2.The Schirmer I test result is less than 5 mm/5 minutes; 3. TBUT is positive for corneal fluorescein staining (CFS) between 5 and 10 seconds; 4. The Schirmer I test result is positive for CFS between 5 mm/5 minutes and 10 mm/5 minutes.

Exclusion criteria

Exclusion criteria: 1. Allergic to sodium fluorescein; 2. History of eye surgery or trauma in the past 3 months; 3.Less than one month after lacrimal punctum occlusion; 4. Active eye infections in the past month; 5. History of intraocular inflammation or uveitis; 6. History of viral keratitis; 7. Oral antibiotics or topical antibiotic eye drops taken within the past month; 8. Within the past month, oral or topical use of glucocorticoids, nonsteroidal anti-inflammatory drugs, cyclosporine, or immunosuppressants on the ocular surface; 9.Use artificial tears within 24 hours prior to the study; 10. Have used Diquat Sodium Eye Drops or Cyclosporine Eye Drops within one month prior to the stud; 11. Other conditions deemed inappropriate by investigators.

Design outcomes

Primary

MeasureTime frame
tear break-up time;schirmer-I test;ocular surface disease index;Ligamine green staining of conjunctiva;Determination of ocular surface microbiota;Corneal fluorescein sodium staining;

Countries

China

Contacts

Public ContactGong Lan

Eye & ENT Hospital of Fudan University

613542953@qq.com+86 135 0179 8683

Outcome results

None listed

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