Brief Summary

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Official Title: "Topical Betaxolol for the Prevention of Retinopathy of Prematurity"

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

• 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
• Study Primary Completion Date: November 2011

Detailed Clinical Trial 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 Used in this Clinical Trial

• Drug: Betaxolol
• Drug: topical betaxolol
  • given topically

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: betaxolol
  • betaxolol 0.25% 2 per day for 3 weeks
• Placebo Comparator: placebo
  • masked labeling also 2 per day administration

Outcome Measures for this Clinical Trial

Primary Measures

• development of apnea and or bradycardia
  • Time Frame: 3 weeks
    Safety Issue?: Yes

Secondary Measures

• development of ROP requiring treatment
  • Time Frame: 7 weeks
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

• <1251 grms birth weight

Exclusion Criteria

• ocular defect

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 32 Weeks

Maximum Age for this Clinical Trial: 32 Weeks

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • Smith-Kettlewell Eye Research Institute
• Collaborator
  • Ohio State University
• Provider of Information About this Clinical Study
  • Principal Investigator: William V Good, MD, Administrator - Smith-Kettlewell Eye Research Institute