drugset / Trial / NCT00634972

Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity

NCT00634972

Phase 4 Terminated 83 enrolled University of South Alabama
RandomizedParallel-groupTriple-blindPrevention

Summary

The purpose of this study is to test whether ACULAR, a nonsteroidal anti-inflammatory eye drop medication, can prevent the development of retinopathy of prematurity (ROP) and/ or decrease its severity.In this study ACULAR will be compared to a placebo (artificial tear). The hypothesis would be that ACULAR treatment will decrease the incidence of moderate to severe ROP (grade II and above)by 50%.

Timeline

Start
2005-11
Primary completion
2008-08
Completion
2008-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketorolac Tromethamine Small molecule Topical
Background Refresh Tears Unknown Topical