Topical Betaxolol for the Prevention of Retinopathy of Prematurity

This study has been completed.
Sponsor:
Collaborators:
Ohio State University
University of Minnesota - Clinical and Translational Science Institute
University of Oklahoma
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
William V Good, MD, Smith-Kettlewell Eye Research Institute
ClinicalTrials.gov Identifier:
NCT01660620
First received: August 6, 2012
Last updated: January 2, 2013
Last verified: August 2012
  Purpose

We hypothesize that topical betaxolol will reduce the development of severe retinopathy of prematurity.


Condition Intervention Phase
Development of Side Effects From Betaxolol
Drug: Betaxolol
Drug: topical betaxolol
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Topical Betaxolol for the Prevention of Retinopathy of Prematurity

Resource links provided by NLM:


Further study details as provided by Smith-Kettlewell Eye Research Institute:

Primary Outcome Measures:
  • development of apnea and or bradycardia [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
    babies were monitored and HR/RR monitored and recorded by masked observers, periodically


Secondary Outcome Measures:
  • development of ROP requiring treatment [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    Type I ROP was used as a secondary outcome measure


Enrollment: 23
Study Start Date: April 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   32 Weeks to 32 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • <1251 grms birth weight

Exclusion Criteria:

  • ocular defect
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: William V Good, MD, Administrator, Smith-Kettlewell Eye Research Institute
ClinicalTrials.gov Identifier: NCT01660620     History of Changes
Other Study ID Numbers: 108298
Study First Received: August 6, 2012
Last Updated: January 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Smith-Kettlewell Eye Research Institute:
betaxolol/ retinopathy of prematurity

Additional relevant MeSH terms:
Retinal Diseases
Retinopathy of Prematurity
Eye Diseases
Infant, Newborn, Diseases
Infant, Premature, Diseases
Betaxolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Antihypertensive Agents
Autonomic Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympatholytics
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014