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Safety and efficacy of L002 in moderate to severe dry eye: a randomized, double-blind, parallel-controlled trial

Safety and efficacy of L002 in moderate to severe dry eye: a randomized, double-blind, parallel-controlled trial

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800018447
Enrollment
Unknown
Registered
2018-09-19
Start date
2018-10-01
Completion date
Unknown
Last updated
2018-09-24

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

Conditions

Dry Eye

Interventions

Group 1:Solvent Eye drop
Group 2:CsA Eye drop
Group 3:L002 Eye drop

Sponsors

Eye Institute of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Voluntary participation in this clinical study, and signed informed consent; 2. Male and female aged 18 ~ 70 years; 3. Clinical signs andsymptoms of dry eye,clinical examination in accordance with the "dry eye expert consensus" diagnostic criteria (as follows): (1) There is dryness, foreign body sensation, burning sensation, fatigue, discomfort, visual fluctuation of subjective symptoms andBUT of less than 5 seconds or Schirmer I test (without surface anesthesia) less than 5mm/5min; (2) There is dryness, foreign body sensation, burning sensation, fatigue, discomfort, visual fluctuation of subjective symptoms andBUT between 5 to 10s or 5 10s sec, Schirmer I test> 10mm / 5mm.

Exclusion criteria

Exclusion criteria: 1. limbal stem cell abnormalities or other causes of ocular surface diseases, such as chemical injuries, thermal burns; 2. Fungal,bacterial or viral keratoconjunctivitis; 3. Combine with other conjunctival, corneal and iris lesions; 4. Have eye surgery or eye injury within 6 months; 5. hormone replacement therapy; 6. Systemic diseases and other eye diseases that affect the evaluation of efficacy; 7. Severe dry eye or filamentary keratitis; 8. The recent use of eye drop treatment; 9. According to the judgment of the doctors that it is not suitable in the study.

Design outcomes

Primary

MeasureTime frame
Schirmer Test;TBUT;Corneal staining scores;Conjunctival staining scores;conjunctival congestion;Irritation score;naked vision;Tear collection;impression cytology;intraocular pressure;

Countries

China

Contacts

Public ContactZuguo Liu

Eye Institute of Xiamen University

zuguoliu@xmu.edu.cn+86 18959289999

Outcome results

None listed

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