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Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity

NCT ID: NCT00634972

Last Updated: 2020-12-08

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-08-31

Brief Summary

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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

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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

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Retinopathy of Prematurity Retinal Detachment Blindness

Keywords

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Retinopathy of Prematurity Premature Infants ACULAR Refresh Tears

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type EXPERIMENTAL

ACULAR

Intervention Type DRUG

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

Intervention Type DRUG

infants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours.

2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

placebo

Intervention Type DRUG

Other Intervention Names

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Acular LS 0.4% 5 mL - from Allergan REFRESH TEARS 0.1 fl oz - from Allergan

Eligibility Criteria

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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
Minimum Eligible Age

10 Days

Maximum Eligible Age

15 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of South Alabama

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabien G Eyal, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Of South Alabama, Children's & Women's Hospital

Locations

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Division of Neonatology, Children's & Women's Hospital, University of South Alabama

Mobile, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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05-156

Identifier Type: -

Identifier Source: secondary_id

05-156

Identifier Type: -

Identifier Source: org_study_id