Topical Betaxolol for the Prevention of Retinopathy of Prematurity

NCT ID: NCT01660620

Last Updated: 2013-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Development of Side Effects From Betaxolol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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betaxolol

betaxolol 0.25% 2 per day for 3 weeks

Group Type EXPERIMENTAL

Betaxolol

Intervention Type DRUG

placebo

masked labeling also 2 per day administration

Group Type PLACEBO_COMPARATOR

topical betaxolol

Intervention Type DRUG

given topically

Interventions

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Betaxolol

Intervention Type DRUG

topical betaxolol

given topically

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* \<1251 grms birth weight

Exclusion Criteria

* ocular defect
Minimum Eligible Age

32 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University

OTHER

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role collaborator

University of Oklahoma

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role collaborator

Smith-Kettlewell Eye Research Institute

OTHER

Sponsor Role lead

Responsible Party

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William V Good, MD

Administrator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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108298

Identifier Type: -

Identifier Source: org_study_id

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