Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity

Retinopathy of Prematurity Clinical Trial

— ROP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00634972
• Other study ID #: 05-156
• Secondary ID: 05-156
• Status: Terminated
• Phase: Phase 4
• Start date: November 2005
• Est. completion date: August 2008

Study information

• Verified date: December 2020
• Source: University of South Alabama
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 83
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 15 Days

Eligibility

Inclusion Criteria:

• All preterm infants of gestational age less or equal to 28 weeks completed gestational age and 10 to 15 days of postnatal age admitted to our regional NICU

Related Conditions & MeSH terms

• Blindness
• Premature Birth
• Retinal Detachment
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

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.
• 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.
• placebo

Locations

Country	Name	City	State
United States	Division of Neonatology, Children's & Women's Hospital, University of South Alabama	Mobile	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of South Alabama

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of ACULAR Compared to Placebo in Inhibiting the Development of Retinopahty of Prematurity in a High Risk Very Immature Preterm Group of Infants		3-4 years