Topical Betaxolol for the Prevention of Retinopathy of Prematurity

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01660620

Enrollment

Registered

2012-08-08

Start date

2011-04-30

Completion date

2011-11-30

Last updated

2013-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Development of Side Effects From Betaxolol

Keywords

betaxolol/ retinopathy of prematurity

Brief summary

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.

Interventions

DRUGBetaxolol

DRUGtopical betaxolol

given topically

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

32 Weeks to 32 Weeks

Healthy volunteers

Inclusion criteria

* \<1251 grms birth weight

Exclusion criteria

* ocular defect

Design outcomes

Primary

Measure	Time frame	Description
development of apnea and or bradycardia	3 weeks	babies were monitored and HR/RR monitored and recorded by masked observers, periodically

Secondary

Measure	Time frame	Description
development of ROP requiring treatment	7 weeks	Type I ROP was used as a secondary outcome measure

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026