Topical Betaxolol for the Prevention of Retinopathy of Prematurity

January 2, 2013 updated by: William V Good, MD, Smith-Kettlewell Eye Research Institute
We hypothesize that topical betaxolol will reduce the development of severe retinopathy of prematurity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • <1251 grms birth weight

Exclusion Criteria:

  • ocular defect

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
given topically

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smith-Kettlewell Eye Research Institute

Collaborators

The University of Texas Health Science Center, Houston
University of Oklahoma
Ohio State University
University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

August 6, 2012

First Submitted That Met QC Criteria

August 7, 2012

First Posted (Estimate)

August 8, 2012

Study Record Updates

Last Update Posted (Estimate)

January 3, 2013

Last Update Submitted That Met QC Criteria

January 2, 2013

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 108298

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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