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Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity

NCT00634972 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2020-12-08

Study results available
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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%.

Conditions

  • Retinopathy of Prematurity
  • Retinal Detachment
  • Blindness

Interventions

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

Sponsors & Collaborators

  • University of South Alabama

    lead OTHER

Principal Investigators

  • Fabien G Eyal, M.D. · University Of South Alabama, Children's & Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
10 Days
Max Age
15 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00634972 on ClinicalTrials.gov