A Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Nepafenac Ophthalmic Suspension 0.3% w/v compared to Bromfenac Ophthalmic Solution 0.09% w/v in the treatment of Pain and Inflammation post Cataract Surgery.
- Conditions
- Disorders of the eye following cataract surgery, Pain and Inflammation in the Eye associated with Cataract Surgery,
- Registration Number
- CTRI/2017/04/008299
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
This study is A Multicentric, Double Blind, Randomized,Active Control, Parallel Group Comparative Study to Evaluate the Efficacy,Safety and Tolerability of Nepafenac Ophthalmic Suspension 0.3 % w/v Vs.Bromfenac Ophthalmic Solution 0.09% w/v in the treatment of Patients with Painand Inflammation in the Eye associated with Cataract Surgery.
Primary objective of this study is to assess Ocularinflammation. Secondary objective of the study is to assess the Ocular pain andnumber of patients pain free at each visit post cataract surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 278
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ocular inflammation as assessed by the investigator during slit lamp examination Day 1,Day 7,Day 14
- Secondary Outcome Measures
Name Time Method Ocular pain will be assessed using a categorical scale. Percentage of patients Pain Free at each visit post cataract surgery.
Trial Locations
- Locations (18)
Bhagwan mahaveer Jain Hospital
🇮🇳Bangalore, KARNATAKA, India
BJ Medical College & Civil Hospital
🇮🇳Ahmadabad, GUJARAT, India
BYL Nair Ch. Hospital and TN Medical College
🇮🇳Mumbai, MAHARASHTRA, India
Christian Medical College and Hospital
🇮🇳Ludhiana, PUNJAB, India
Dr. R.S.P.R. Government Regional Eye Hospital
🇮🇳Visakhapatnam, ANDHRA PRADESH, India
Gandhi Hospital
🇮🇳Hyderabad, ANDHRA PRADESH, India
GMERS Medical College and Civil Hospital
🇮🇳Ahmadabad, GUJARAT, India
IPGME&R, SSKM Hospital
🇮🇳Kolkata, WEST BENGAL, India
Kakatiya Medical College
🇮🇳Warangal, ANDHRA PRADESH, India
Kanoria Hospital & Research Center
🇮🇳Gandhinagar, GUJARAT, India
Scroll for more (8 remaining)Bhagwan mahaveer Jain Hospital🇮🇳Bangalore, KARNATAKA, IndiaDr Rajesh ParekhPrincipal investigator9945544744eyetrials@gmail.com