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A Randomised Control Trial of Eyedrops of Liposome Encapsulated Indomethacine

A Randomised Phase II Trial of evaluation the efficacy and safety of Eyedrops of Liposome encapsulated Indomethacin for antiinflammation following Phacoemulsification cataract surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-09000435
Enrollment
Unknown
Registered
2009-06-07
Start date
2007-01-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Inflammatory reaction following cataract phacoemulsification surgery

Interventions

Group A:Loposome Encapsulate Indomethacin Eyedrops after phacoemulsification cataract surgery
Group B:Indomethacin Eyedrops after phacoemulsification cataract surgery

Sponsors

LiBo Pharmaceuticals Science & Technology Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Both male and female subjects with cataract at the age from 18(18 included) to 70; 2. It is clinical definite cataract and indication of phacoemulsification; 3. Subjects have read the subject notice, consented to the treatment and signed a written informed consent form; 4. Subjects would and were able to visit timely in accordance with the requirements.

Exclusion criteria

Exclusion criteria: 1. Systemic inflammation or ocular infection; 2. Combining with glaucoma, uveitis, and traumatic cataract; 3.Pseudo-exfoliation syndrome; 4.Women during pregnancy or lactation; 5. Corneal endothelial cell decompensation; 6. Progressive ocular changes of severe diabetic; 7. Serious heart, lung, liver, kidney dysfunction; 8. Patients suffering from neurological, mental illness, serious endocrine disease or tumor; 9.Patients of systemic autoimmune disease or requiring long-term use of corticosteroids and immunosuppressant; 10. Subjects had accepted local corticosteroids medication two weeks before selected; 11. Subjects had participated in other drug clinical trials four weeks before selected; 12. Subjects that did not fill out the informed consent form and be not able to describes the state of an illness; 13. Subjects with severe complications during phacoemulsification.

Design outcomes

Primary

MeasureTime frame
change of flare;Improvement;cells of Anterior Chambe;

Secondary

MeasureTime frame
scores of symptoms and signs before and after applying eyedrops;

Contacts

Public ContactMingxing Wu
wumingx@mail.sysu.edu.cn+86 020 87330294

Outcome results

None listed

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