Development of Side Effects From BetaxololPhase 1NCT01660620
Topical Betaxolol for the Prevention of Retinopathy of Prematurity
A Phase 1 study testing Betaxolol and topical betaxolol in people with Development of Side Effects From Betaxolol, run by Smith-Kettlewell Eye Research Institute.
Trial summary
We hypothesize that topical betaxolol will reduce the development of severe retinopathy of prematurity. Read more about this study
- Who is it for?
- Ages 32 to 32 weeks
- Conditions the study is for
- Development of Side Effects From Betaxolol
- What is being tested?
- Betaxolol and topical betaxolol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Nov 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 32 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- <1251 grms birth weight
Who cannot join
- ocular defect
About this study
We hypothesize that topical betaxolol will reduce the development of severe retinopathy of prematurity.
Read the detailed description
The drug is administered twice a day between 32 and 35 weeks gestational age, at a t ime when ROP is most likely to arise.
- Being tested
- Betaxolol, topical betaxolol
- Keywords
- betaxolol/ retinopathy of prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetaxololDrug
topical betaxololDrug
given topically
| Study group | Role | What they receive |
|---|---|---|
| betaxolol | Experimental | betaxolol 0.25% 2 per day for 3 weeks Receives: Drug: Betaxolol |
| placebo | Placebo comparator | masked labeling also 2 per day administration Receives: Drug: topical betaxolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of apnea and or bradycardia
babies were monitored and HR/RR monitored and recorded by masked observers, periodically
Measured: 3 weeks
Secondary outcomes (1)
development of ROP requiring treatment
Type I ROP was used as a secondary outcome measure
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startApr 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Development of Side Effects From BetaxololStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith-Kettlewell Eye Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University, University of Minnesota, University of Oklahoma, The University of Texas Health Science Center, Houston
- Responsible party
- Principal investigator, William V Good, MD, Smith-Kettlewell Eye Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660620
- Sponsor's protocol ID
- 108298
- Status last verified
- Aug 2012
- First submitted
- 6 Aug 2012
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Betaxolol for the Prevention of Retinopathy of Prematurity
- ClinicalTrials.gov ID
- NCT01660620
- Acronym / sponsor ID
- 108298
- Keywords
- betaxolol/ retinopathy of prematurity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Smith-Kettlewell Eye Research InstituteUniversity, hospital or other
- Collaborators
- Ohio State University, University of Minnesota, University of Oklahoma, The University of Texas Health Science Center, Houston
- Study start
- Apr 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 8 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We hypothesize that topical betaxolol will reduce the development of severe retinopathy of prematurity.
Detailed description
The drug is administered twice a day between 32 and 35 weeks gestational age, at a t ime when ROP is most likely to arise.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| betaxolol | Experimental | Drug: Betaxololbetaxolol 0.25% 2 per day for 3 weeks |
| placebo | Placebo comparator | Drug: topical betaxololmasked labeling also 2 per day administration |
Who may qualify
- Ages
- 32 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- <1251 grms birth weight
Key exclusion criteria (1 listed)
- ocular defect
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 |
|---|---|---|
| Betaxolol | Drug | betaxolol |
| topical betaxololgiven topically | Drug | placebo |
Primary outcome
development of apnea and or bradycardia
Time frame: 3 weeks
babies were monitored and HR/RR monitored and recorded by masked observers, periodically
1 secondary outcome
development of ROP requiring treatment
Time frame: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Betaxolol and topical betaxolol in people with Development of Side Effects From Betaxolol, run by Smith-Kettlewell Eye Research Institute.
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 1 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: finished, as of the sponsor's last update on 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
development of apnea and or bradycardia (time frame: 3 weeks). 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 3 Jan 2013.