Ocular inflammation and pain following ophthalmic surgery
Conditions
Interventions
Test group:Dexamethasone Ophthalmic Insert
Sponsors
Boao Super Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Aged = 18 years old at screening; 2) With a cataract and is expected to undergo phacoemulsification cataract surgery with clear corneal incision and implantation of a posterior chamber intraocular lens;
Exclusion criteria
Exclusion criteria: 1) Currently have suspected or known malignancy or currently receiving anti-tumor therapies; 2) Pregnant or lactating women; women who plan to become pregnant during the study; or women of child-bearing potential (i.e., non-menopausal or not surgically sterilized women) who will not use adequate contraception methods; 3) Subjects with glaucoma or receiving anti-glaucoma medication; 4) With active or history of chronic or recurrent inflammatory eye diseases (e.g., iritis, scleritis, uveitis, iridocyclitis, rubeosis iritis) in the study eye; 5) With evidence of acute external ocular infections (bacterial, viral and/or fungal infections such as smallpox, varicella, and other viral diseases of the cornea and conjunctiva); tuberculosis of the eye; corneal dystrophies; active corneal ulcers, intraocular infections, dysthyroid ophthalmopathy, active chalazion, or uncontrolled blepharitis in the study eye; 6) Subjects with unexplained diseases (e.g., systemic or other ocular disorders or abnormalities) whose enrollment may compromise the subject’s health or the validity of the study results are ineligible, as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence of cells (i.e., score of '0') in the anterior chamber of the study eye at Day 14; | — |
Secondary
| Measure | Time frame |
|---|---|
| Absence of pain (i.e., score of '0') in the study eye at Day 8;Absence of cells in the anterior chamber of the study eye at Days 2, 8 and 30;Absence of pain in the study eye at Days 2,14, and 30; | — |
Countries
China
Contacts
Public ContactWei Chen
Boao Super Hospital
Outcome results
None listed