Retinopathy of PrematurityPhase 4ROPNCT00634972
Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity
A Phase 4 study testing ACULAR and REFRESH TEARS in people with Retinopathy of Prematurity and Retinal Detachment, run by University of South Alabama at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 to 15 daysHealthy volunteers can take part
- Conditions the study is for
- Retinopathy of Prematurity, Retinal Detachment, Blindness
- What is being tested?
- ACULAR and REFRESH TEARS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Aug 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Division of Neonatology, Children's & Women's Hospital, University of South Alabama
Mobile, Alabama, 36604-3391
About this study
Official title: Topical Application of ACULAR a Randomized, Vehicle Controlled Clinical Trial: Efficiency in Inhibiting Proliferative Retinopathy of Prematurity
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%.
Read the 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.
- Conditions
- Retinopathy of Prematurity, Retinal Detachment, Blindness
- Being tested
- ACULAR, REFRESH TEARS, placebo
- Keywords
- Retinopathy of Prematurity, Premature Infants, ACULAR, Refresh Tears
- Medical subject headings
- Retinopathy of Prematurity, Retinal Detachment, Blindness, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACULARDrug
Also called 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.
REFRESH TEARSDrug
Also called REFRESH TEARS 0.1 fl oz, - 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.
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: ACULAR; Drug: REFRESH TEARS |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of ACULAR Compared to Placebo in Inhibiting the Development of Retinopahty of Prematurity in a High Risk Very Immature Preterm Group of Infants
Measured: 3-4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startNov 2005
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: The study could not be completed as the company producing this product interrupted their supply of this medication
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Alabama
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabien G Eyal, M.D., Principal investigator, University Of South Alabama, Children's & Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634972
- Sponsor's protocol ID
- 05-156
- Other IDs
- 05-156
- Acronym
- ROP
- Status last verified
- Dec 2020
- First submitted
- 5 Mar 2008
- Last updated
- 8 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Application of ACULAR a Randomized, Vehicle Controlled Clinical Trial: Efficiency in Inhibiting Proliferative Retinopathy of Prematurity
- ClinicalTrials.gov ID
- NCT00634972
- Acronym / sponsor ID
- ROP / 05-156
- Conditions
- Retinopathy of Prematurity, Retinal Detachment, Blindness
- Keywords
- Retinopathy of Prematurity, Premature Infants, ACULAR, Refresh Tears
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study could not be completed as the company producing this product interrupted their supply of this medication
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of South AlabamaUniversity, hospital or other
- Study start
- Nov 2005 (actual)
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 13 Mar 2008 (estimated)
- Results
- Posted 8 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ACULAR, Drug: REFRESH TEARS |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 10 to 15 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACULARAlso: Acular LS 0.4% 5 mL, - from Allerganinfants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours. | Drug | 1 |
| REFRESH TEARSAlso: REFRESH TEARS 0.1 fl oz, - from Allerganinfants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours. | Drug | 1 |
| placebo | Drug | 2 |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Retinopathy of Prematurity
RecruitingObservational study
An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)
Retinopathy of Prematurity, Preterm Infants
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
RecruitingObservational study
Imaging Retinal Vasculature in Infant Eyes
Retinopathy of Prematurity
RecruitingPhase 1
Safety, PK and PD of FLQ-101 in Premature Neonates
Retinopathy of Prematurity (ROP)
Recruiting
Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care
Retinopathy of Prematurity (ROP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabien G Eyal, M.D. principal investigator
University Of South Alabama, Children's & Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ACULAR and REFRESH TEARS in people with Retinopathy of Prematurity and Retinal Detachment, run by University of South Alabama at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.