NCT00634972

Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity

Topical Application of ACULAR a Randomized, Vehicle Controlled Clinical Trial: Efficiency in Inhibiting Proliferative Retinopathy of Prematurity

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: University of South Alabama · Academic / Other
• Sex: All
• Age: 10 Days – 15 Days
• Healthy volunteers: Accepted

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%.

Detailed description

Each year ROP affects an estimated 14,000-16,000 premature, low birth weight infants in the United States and thousands more worldwide, making it a leading cause of vision loss in children. Of these cases, approximately 1500 infants will develop severe ROP that requires surgical treatment. Despite those treatment, about 400-600 infants with severe ROP still become legally blind each year. ACULAR® (Ketorolac eye drop) is a member of nonsteroidal anti-inflammatory drugs (NSAIDs) available for toipcal ocular use. ACULAR acts as prostaglandin inhibitor and as such decrease prostaglandin E2 production. An increase in prostaglandin production has been associated with various inflammatory eye disease.For instance ACULAR has been shown to be effective in preventing the post cataract surgery inflammation that result in macular edema in adults. Activation of the prostaglandin cascade has been demonstrated in animal models of ROP. A previous non randomized study using ACULAR for ROP prevention has shown a possible beneficial effect and no observed adverse effect. To clearly demonstrated and confirm this finding a randomized study is thus necessary before one can advocate its use for prevention of ROP.The medication is FDA approved in pediatrics for allergic conjunctivitis and post surgical ocular inflammation.

Conditions

• Retinopathy of Prematurity
• Retinal Detachment
• Blindness

Interventions

Type	Name	Description
DRUG	ACULAR	infants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours.
DRUG	REFRESH TEARS	infants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours.
DRUG	placebo

Timeline

• Start date: 2005-11-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2008-03-13
• Last updated: 2020-12-08
• Results posted: 2020-12-08

Locations

1 site across 1 country: United States