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Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity (ROP)

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ClinicalTrials.gov Identifier: NCT00634972
Recruitment Status : Unknown
Verified March 2008 by University of South Alabama.
Recruitment status was:  Enrolling by invitation
First Posted : March 13, 2008
Last Update Posted : March 13, 2008
Information provided by:
University of South Alabama

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%.

Condition or disease Intervention/treatment Phase
Retinopathy of Prematurity Retinal Detachment Blindness Drug: ACULAR Drug: REFRESH TEARS Drug: placebo Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Topical Application of ACULAR a Randomized, Vehicle Controlled Clinical Trial: Efficiency in Inhibiting Proliferative Retinopathy of Prematurity
Study Start Date : November 2005
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : December 2009

Arm Intervention/treatment
Experimental: 1 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.
Other Names:
  • Acular LS 0.4% 5 mL
  • - from Allergan
infants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours.
Other Names:
  • REFRESH TEARS 0.1 fl oz
  • - from Allergan
Placebo Comparator: 2 Drug: placebo

Primary Outcome Measures :
  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 [ Time Frame: 3-4 years ]

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Ages Eligible for Study:   up to 15 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00634972

United States, Alabama
Division of Neonatology, Children's & Women's Hospital, University of South Alabama
Mobile, Alabama, United States, 36604-3391
Sponsors and Collaborators
University of South Alabama
Principal Investigator: Fabien G Eyal, M.D. University Of South Alabama, Children's & Women's Hospital

Responsible Party: Fabien G. Eyal, M.D., University of South Alabama, Children's and Women' s Hospital
ClinicalTrials.gov Identifier: NCT00634972     History of Changes
Other Study ID Numbers: 05-156
First Posted: March 13, 2008    Key Record Dates
Last Update Posted: March 13, 2008
Last Verified: March 2008

Keywords provided by University of South Alabama:
Retinopathy of Prematurity
Premature Infants
Refresh Tears

Additional relevant MeSH terms:
Retinal Diseases
Premature Birth
Retinal Detachment
Retinopathy of Prematurity
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action