Topical Betaxolol for the Prevention of Retinopathy of Prematurity

Smith-Kettlewell Eye Research Institute

Status and phase: Completed; Phase 1

Conditions: Development of Side Effects From Betaxolol

Treatments: Drug: topical betaxolol; Drug: Betaxolol

Study type: Interventional

Funder types: Other

Identifiers

NCT01660620

108298

Details and patient eligibility

About

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

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 32 to 32 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• <1251 grms birth weight

Exclusion criteria

• ocular defect

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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23 participants in 2 patient groups, including a placebo group

betaxolol

Experimental group

Description:

betaxolol 0.25% 2 per day for 3 weeks

Treatment:

Drug: Betaxolol

placebo

Placebo Comparator group

Description:

masked labeling also 2 per day administration

Treatment:

Drug: topical betaxolol