ROP: Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity

Sponsor
University of South Alabama (Other)
Overall Status
Terminated
CT.gov ID
NCT00634972
Collaborator
(none)
83
1
2
33
2.5

Study Details

Study Description

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
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.

ACULARĀ® (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 Design

Study Type:
Interventional
Actual Enrollment :
83 participants
Allocation:
Randomized
Intervention Model:
Parallel 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
Actual Study Start Date :
Nov 1, 2005
Actual Primary Completion Date :
Aug 1, 2008
Actual Study Completion Date :
Aug 1, 2008

Arms and Interventions

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
  • 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

    Outcome Measures

    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 [3-4 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Days to 15 Days
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of South Alabama
    ClinicalTrials.gov Identifier:
    NCT00634972
    Other Study ID Numbers:
    • 05-156
    • 05-156
    First Posted:
    Mar 13, 2008
    Last Update Posted:
    Dec 8, 2020
    Last Verified:
    Dec 1, 2020

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title 1 Drop of the ROP Study Drug Placebo
    Arm/Group Description 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. 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. placebo
    Period Title: Overall Study
    STARTED 40 43
    COMPLETED 40 43
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title 1 Drop of the ROP Study Drug Placebo Total
    Arm/Group Description 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. 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. placebo Total of all reporting groups
    Overall Participants 40 43 83
    Age (Count of Participants)
    <=18 years
    40
    100%
    43
    100%
    83
    100%
    Between 18 and 65 years
    0
    0%
    0
    0%
    0
    0%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    22
    55%
    19
    44.2%
    41
    49.4%
    Male
    18
    45%
    24
    55.8%
    42
    50.6%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Efficacy of ACULAR Compared to Placebo in Inhibiting the Development of Retinopahty of Prematurity in a High Risk Very Immature Preterm Group of Infants
    Description
    Time Frame 3-4 years

    Outcome Measure Data

    Analysis Population Description
    The study was prematurely interrupted. As we could not achieve the recruitment of a sufficient number of patients that was required to reach the preplanned power for a statistically significant results, no data analysis was completed.
    Arm/Group Title 1 Drop of the ROP Study Drug Placebo
    Arm/Group Description 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. 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. placebo
    Measure Participants 0 0

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title 1 Drop of the ROP Study Drug Placebo
    Arm/Group Description 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. 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. placebo
    All Cause Mortality
    1 Drop of the ROP Study Drug Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    1 Drop of the ROP Study Drug Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/40 (0%) 0/43 (0%)
    Other (Not Including Serious) Adverse Events
    1 Drop of the ROP Study Drug Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/40 (0%) 0/43 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Fabien Eyal, MD
    Organization University of South Alabama
    Phone 251-415-1055
    Email feyal@health.southalabama.edu
    Responsible Party:
    University of South Alabama
    ClinicalTrials.gov Identifier:
    NCT00634972
    Other Study ID Numbers:
    • 05-156
    • 05-156
    First Posted:
    Mar 13, 2008
    Last Update Posted:
    Dec 8, 2020
    Last Verified:
    Dec 1, 2020