NCT00061542

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of BETOPTIC S and Timolol Gel-forming solution in pediatric patients. Patients will dose with study drug at 8 am and 8 pm daily for twelve weeks. Patients will have vision tested, slit lamp exam, blood pressure and pulse checks at each visit. Patients will have a dilated fundus exam and corneal measurements taken at first and last visit.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2003

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2003

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

November 18, 2016

Status Verified

August 1, 2008

Enrollment Period

3.8 years

First QC Date

May 28, 2003

Last Update Submit

November 16, 2016

Conditions

GlaucomaOcular Hypertension

Keywords

GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Mean change from baseline in IOP

    Up to Week 12

Study Arms (3)

Betaxolol

EXPERIMENTAL

Two doses daily for 12 weeks

Drug: BETOPTIC S (betaxolol HCl)

TGFS 0.25%

EXPERIMENTAL

Two doses daily for 12 weeks

Drug: Timolol Gel-forming Solution (TGFS)

TGFS 0.5%

EXPERIMENTAL

Two doses daily for 12 weeks

Drug: Timolol Gel-forming Solution (TGFS)

Interventions

BETOPTIC S (betaxolol HCl)DRUG

betaxolol HC)

Betaxolol
Timolol Gel-forming Solution (TGFS)DRUG

timolol maleate 0.25% and 0.5%

TGFS 0.25%TGFS 0.5%

Eligibility Criteria

Age1 Week - 5 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children 5 years old and younger
  • require treatment for glaucoma or ocular hypertension
  • whose vision is 20/80 or better
  • have a cup-to-disc ratio of 0.8 or less

You may not qualify if:

  • do not have abnormal fixation
  • IOP greater than 36 mm Hg
  • significant retinal disease
  • penetrating keratoplasty
  • severe ocular pathology
  • optic atrophy
  • eye surgery in the past 30 days
  • cardiovascular abnormalities
  • hypersensitivity to beta blockers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alcon Call Center

Fort Worth, Texas, United States

Location

Related Publications (1)

  • Plager DA, Whitson JT, Netland PA, Vijaya L, Sathyan P, Sood D, Krishnadas SR, Robin AL, Gross RD, Scheib SA, Scott H, Dickerson JE; BETOPTIC S Pediatric Study Group. Betaxolol hydrochloride ophthalmic suspension 0.25% and timolol gel-forming solution 0.25% and 0.5% in pediatric glaucoma: a randomized clinical trial. J AAPOS. 2009 Aug;13(4):384-90. doi: 10.1016/j.jaapos.2009.04.017.

    PMID: 19683191RESULT

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Interventions

Betaxolol

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2003

First Posted

May 30, 2003

Study Start

January 1, 2003

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

November 18, 2016

Record last verified: 2008-08

Locations

US(1)