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Safety and efficacy of Haoshili middle aged eye patch in dry eye caused by meibomian gland dysfunction: a randomized, double-blind, parallel-controlled trial

Safety and efficacy of Haoshili middle aged eye patch in dry eye caused by meibomian gland dysfunction: a randomized, double-blind, parallel-controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800019984
Enrollment
Unknown
Registered
2018-12-11
Start date
2018-12-12
Completion date
Unknown
Last updated
2018-12-18

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:No eye patch
Group 2:Eye patch

Sponsors

Eye Institute of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Voluntary participation in this clinical study, and signed informed consent; 2. Male and female aged 40 ~ 80 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 < Schirmer I test (without surface anesthesia) <=10mm/5min. At the same time with conjunctival andcorneal fluorescein staining; 4. Clinical signs andsymptoms of dry eye, clinical examination in accordance with the 'Meibomian gland dysfunction expert consensus' diagnostic criteria (as follows): (1) Abnormal openings of meibomian glands; (2) Abnormal blepharose secretion; (3) Dry eye symptoms); (4) Absence of meibomian gland; (5) Abnormal lipid thickness.5. the choice of study eyes: If patients were treated with both eyes, the eye of the patient with high symptom score was studied.

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
conjunctival congestion;Corneal staining scores;conjunctival staining scores;naked vision;intraocular pressure;Schirmer Test;TBUT;subjective symptoms;lid margin;meibomian gland assessment;Infrared meibomian gland imaging;lipid layer thickness;

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