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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University of South Alabama
ClinicalTrials.gov Identifier:
NCT00634972
First received: March 5, 2008
Last updated: March 12, 2008
Last verified: March 2008
  Purpose

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 Intervention Phase
Retinopathy of Prematurity
Retinal Detachment
Blindness
Drug: ACULAR
Drug: REFRESH TEARS
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Topical Application of ACULAR a Randomized, Vehicle Controlled Clinical Trial: Efficiency in Inhibiting Proliferative Retinopathy of Prematurity

Resource links provided by NLM:


Further study details as provided by University of South Alabama:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: November 2005
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
Other Names:
  • REFRESH TEARS 0.1 fl oz
  • - from Allergan
Placebo Comparator: 2 Drug: placebo

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.

  Eligibility

Ages Eligible for Study:   up to 15 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634972

Locations
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
Investigators
Principal Investigator: Fabien G Eyal, M.D. University Of South Alabama, Children's & Women's Hospital
  More Information

No publications provided

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, 05-156
Study First Received: March 5, 2008
Last Updated: March 12, 2008
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 28, 2014