Postsurgical inflammation after cataract intraocular lens implantation
Conditions
Interventions
Control:Diclofenac sodium ophthalmic solution 0.1% (qid),
Test:Bromfenac sodium ophthalmic solution 0.1% (bid), 1
Sponsors
Senju Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
Male
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with post-surgical inflammation after cataract intraocular lens implantation; 2. Score of aqueous flare or aqueous cells >=0.5 and the total symptom score >=2.
Exclusion criteria
Exclusion criteria: 1. Patients with diabetic or traumatic cataract. 2. Patients who are hypersensitive to non-steroid anti-inflammatory drugs. 3. Pregnant or lactating women. 4. Patients with complication of other ocular surface infectious diseases. 5. Patients with serious heart, lung, liver or kidney dysfunction. 6. Disease of the eyelid, lacrimal apparatus and conjunctiva glaucoma and corneal limbal stem cell abnormality; such as incomplete eyelid closure, dry eyes, trichiasis, serious cornea-conjunctiva chemical burning that cannot be recovered concurrently. 7. Patients who are taking other drugs as systemic or topical treatments which can affect the clinical evaluation of test drug, such as glucocorticoid. 8. Patients who cannot guarantee to take drug administration following protocols or receive follow-up visits as requirement. 9. Patients without civil action capability or who can not describe their feelings after taking the drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients exhibiting clinical efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clearing of anterior chamber flare and cell; | — |
Countries
China
Contacts
Public ContactNoritsugu Inui
Outcome results
None listed