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Topical Betaxolol for the Prevention of Retinopathy of Prematurity

Information source: Smith-Kettlewell Eye Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Development of Side Effects From Betaxolol

Intervention: Betaxolol (Drug); topical betaxolol (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Smith-Kettlewell Eye Research Institute


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

Clinical Details

Official title: Topical Betaxolol for the Prevention of Retinopathy of Prematurity

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

Primary outcome: development of apnea and or bradycardia

Secondary outcome: development of ROP requiring 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.


Minimum age: 32 Weeks. Maximum age: 32 Weeks. Gender(s): Both.


Inclusion Criteria:

- <1251 grms birth weight

Exclusion Criteria:

- ocular defect

Locations and Contacts

Additional Information

Starting date: April 2011
Last updated: January 2, 2013

Page last updated: August 23, 2015

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