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Bromday vs Nevanac for Ocular Inflammation in Cataract Surgery
NCT01310127Phase 4
Key facts
- Status
- Completed
- Start
- Nov 2010
- Primary completion
- Apr 2011
- Sponsor
- Toyos Clinic
- Modality
- Small Molecules
- Drugs
- bromfenac sodium
- Conditions
- ocular inflammation
01
Overview
Phase 4, randomised, single-blind trial of bromfenac sodium in ocular inflammation (2 arms), sponsored by Toyos Clinic. Primary endpoints: Early Treatment Diabetic Retinopathy Study Visual Acuities at Week 6, Summed Ocular Inflammation Score at Week 6 and 2 more. Started Nov 2010; status: completed.
02
Design
2 arms- Study design
- RandomizedSingle-blind
Bromday Arm
Bromfenac 0.09% QD
Nevanac Arm
Nepafenac 0.1% TID
03
Who it enrols
Adult patients scheduled for unilateral cataract surgery with posterior chamber IOL implantation, BCVA 20/200 or better, and IOP 5-22 mmHg. Excludes patients with hypersensitivity to NSAIDs, active ocular inflammation, corneal pathology, or recent use of ocular/systemic NSAIDs, steroids, or prostaglandins.
04
Endpoints
Primary
Early Treatment Diabetic Retinopathy Study Visual Acuities
Summed Ocular Inflammation Score
OCT Retinal Thickness
Macular Volume
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