Safety and Efficacy Study of BETOPTIC S 0.25% and Timolol Gel-forming Solution 0.25% and 0.5% in Pediatric Patients With Glaucoma or Ocular Hypertension

November 16, 2016 updated by: Alcon Research
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States
        • Alcon Call Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

INCLUSION:

  • 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

EXCLUSION:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Betaxolol
Two doses daily for 12 weeks
Drug: BETOPTIC S (betaxolol HCl)
betaxolol HC)
Experimental: TGFS 0.25%
Two doses daily for 12 weeks
Drug: Timolol Gel-forming Solution (TGFS)
timolol maleate 0.25% and 0.5%
Experimental: TGFS 0.5%
Two doses daily for 12 weeks
Drug: Timolol Gel-forming Solution (TGFS)
timolol maleate 0.25% and 0.5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change from baseline in IOP
Time Frame: Up to Week 12
Up to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

May 28, 2003

First Submitted That Met QC Criteria

May 29, 2003

First Posted (Estimate)

May 30, 2003

Study Record Updates

Last Update Posted (Estimate)

November 18, 2016

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-01-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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