Health Condition 1: H590- Disorders of the eye following cataract surgery Health Condition 2: null- Pain and Inflammation in the Eye associated with Cataract Surgery
Conditions
Interventions
Intervention1: Nepafenac Ophthalmic Suspension 0.3 % w/v: One drop, once daily for 14 days
Control Intervention1: Bromfenac Ophthalmic Solution 0.09% w/v: One drop, once daily for 14 days
Sponsors
Ajanta Pharma Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and Female patients of age 18 - 70 years (Both inclusive). 2. Planned cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens. 3. Voluntary willingness to give written informed consent prior to participation in trial.
Exclusion criteria
Exclusion criteria: 1. Use of topical ocular, inhaled or systemic nonsteroidal anti-inflammatory drugs within 7 days of surgery, with the exception of the allowed low dose of aspirin (up to 100 mg) prior to surgery and through study exit. 2. Use of any form of steroids -topical, inhaled or systemic steroids within 14 days prior to surgery or local or oral NSAIDs within 7 days of surgery. 3. History of chronic or recurrent inflammatory eye disease (eg, iritis, scleritis, uveitis, iridocyclitis, rubeosis iridis) in the operative eye. 4. Pregnant and lactating women. 5. Known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), or to any component of the test article. 6. Subjects with bleeding tendency, dry eye, rheumatoid arthritis, ocular surface disease including epithelial problems. 7. Subject with any surgery which converted from phacoemulsification to extra capsular surgery. 8. Patients with history of ocular surgery, inflammatory eye disease, ocular infection, congenital ocular anomalies, ocular trauma or current signs and symptoms that were associated with these or other ocular conditions. 9. Lens pseudoexfoliation syndrome with glaucoma or zonular compromise or previous ocular trauma. 10. Patients were also excluded if their IOP could not be reliably measured or had planned multiple surgical procedures, lens pseudoexfoliation syndrome with glaucoma or zonular compromise in the operative eye, ocular or systemic inflammatory or diabetic disease, or previous ocular trauma to the operative eye. 11. Patient with Diabetic Retinopathy, Glaucoma and any other Neurological condition. 12. Any other condition(s) that may affect the procedure of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ocular inflammation as assessed by the investigator during slit lamp examinationTimepoint: Day 1,Day 7,Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Ocular pain will be assessed using a categorical scale. Percentage of patients Pain Free at each visit post cataract surgery.Timepoint: Day 1,7,14 | — |
Countries
India
Contacts
Public ContactDr Shailesh Singh
Ajanta Pharma Ltd
Outcome results
None listed