CClinicalTrials.gg
CompletedNCT01660620Updated Jan 3, 2013

Topical Betaxolol for the Prevention of Retinopathy of Prematurity

A Phase 1 interventional study of Betaxolol and topical betaxolol in Development of Side Effects From Betaxolol, sponsored by Smith-Kettlewell Eye Research Institute. Completed. Open to participants aged 32 Weeks to 32 Weeks. Per ClinicalTrials.gov, last updated 2013-01-03.

Sponsored by Smith-Kettlewell Eye Research Institute · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
32 Weeks to 32 Weeks
Sex
All
01

Study summary

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.

02

Conditions studied

  • Development of Side Effects From Betaxolol

Keywords

  • betaxolol/ retinopathy of prematurity
03

In context

Retinal Diseases

815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.

This study's enrollment of 23 is below the median of 60 across 500 interventional studies indexed under Retinal Diseases.

Browse Retinal Diseases studies →

Lead sponsor

Smith-Kettlewell Eye Research Institute is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
32 Weeks to 32 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • \<1251 grms birth weight

Exclusion criteria

Exclusion Criteria:

  • ocular defect
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    betaxolol

    betaxolol 0.25% 2 per day for 3 weeks

    Drug: Betaxolol

  • Placebo comparator
    placebo

    masked labeling also 2 per day administration

    Drug: topical betaxolol

Interventions

  • DrugBetaxolol
  • Drugtopical betaxolol

    given topically

06

What researchers measure

Primary outcomes

  1. development of apnea and or bradycardia

    babies were monitored and HR/RR monitored and recorded by masked observers, periodically

    Time frame: 3 weeks

Secondary outcomes

  1. development of ROP requiring treatment

    Type I ROP was used as a secondary outcome measure

    Time frame: 7 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01660620
Lead sponsor
Smith-Kettlewell Eye Research Institute
Collaborators
Ohio State University, University of Minnesota, University of Oklahoma, The University of Texas Health Science Center, Houston
Responsible party
William V Good, MD (Administrator, Smith-Kettlewell Eye Research Institute) — Principal investigator
First posted
Aug 8, 2012
Start date
Apr 2011
Primary completion
Nov 2011
Completion
Nov 2011
Last update
Jan 3, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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