Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity

NCT00634972 | Terminated Phase 4 Results

• 1 other identifier: 05-156
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Retinopathy of Prematurity; Premature Infants; ACULAR; Refresh Tears

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

Drug: ACULAR; Drug: REFRESH TEARS

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

ACULAR 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.

Also known as: Acular LS 0.4% 5 mL, - from Allergan

1

REFRESH TEARS 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.

Also known as: REFRESH TEARS 0.1 fl oz, - from Allergan

1

placebo DRUG

2

Eligibility Criteria

• Age: 10 Days - 15 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• University of South Alabama: lead

Study Sites (1)

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

Mobile, Alabama, 36604-3391, United States

Location

MeSH Terms

Conditions

Retinopathy of Prematurity; Retinal Detachment; Blindness; Premature Birth

Interventions

Ketorolac Tromethamine; Ketorolac

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Fabien Eyal, MD
• Organization: University of South Alabama

feyal@health.southalabama.edu

251-415-1055

Study Officials

• Fabien G Eyal, M.D.

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2008
• First Posted: March 13, 2008
• Study Start: November 1, 2005
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: December 8, 2020
• Results First Posted: December 8, 2020

Record last verified: 2020-12

Locations

US (1)