ROP: Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity
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
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:
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:
|
Placebo Comparator: 2
|
Drug: placebo
|
Outcome Measures
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 [3-4 years]
Eligibility Criteria
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
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.- 05-156
- 05-156
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
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
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 |
feyal@health.southalabama.edu |
- 05-156
- 05-156