Topical Betaxolol for the Prevention of Retinopathy of Prematurity

Development of Side Effects From Betaxolol Clinical Trial

Official title:

Topical Betaxolol for the Prevention of Retinopathy of Prematurity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01660620
• Other study ID #: 108298
• Status: Completed
• Phase: Phase 1
• First received: August 6, 2012
• Last updated: January 2, 2013
• Start date: April 2011
• Est. completion date: November 2011

Study information

• Verified date: August 2012
• Source: Smith-Kettlewell Eye Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 32 Weeks to 32 Weeks

Eligibility

Inclusion Criteria:

• <1251 grms birth weight

Exclusion Criteria:

• ocular defect

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Development of Side Effects From Betaxolol
• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Drug:
• Betaxolol

• topical betaxolol
given topically

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Smith-Kettlewell Eye Research Institute	Ohio State University, The University of Texas Health Science Center, Houston, University of Minnesota - Clinical and Translational Science Institute, University of Oklahoma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	development of apnea and or bradycardia	babies were monitored and HR/RR monitored and recorded by masked observers, periodically	3 weeks	Yes
Secondary	development of ROP requiring treatment	Type I ROP was used as a secondary outcome measure	7 weeks	No