Back to resultsSafety 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
Primary Purpose
Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
BETOPTIC S (betaxolol HCl)
Timolol Gel-forming Solution (TGFS)
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, Ocular Hypertension
Eligibility Criteria
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
Sites / Locations
- Alcon Call Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Betaxolol
TGFS 0.25%
TGFS 0.5%
Arm Description
Two doses daily for 12 weeks
Two doses daily for 12 weeks
Two doses daily for 12 weeks
Outcomes
Primary Outcome Measures
Mean change from baseline in IOP
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00061542
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension
Keywords
Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Betaxolol
Arm Type
Experimental
Arm Description
Two doses daily for 12 weeks
Arm Title
TGFS 0.25%
Arm Type
Experimental
Arm Description
Two doses daily for 12 weeks
Arm Title
TGFS 0.5%
Arm Type
Experimental
Arm Description
Two doses daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
BETOPTIC S (betaxolol HCl)
Intervention Description
betaxolol HC)
Intervention Type
Drug
Intervention Name(s)
Timolol Gel-forming Solution (TGFS)
Intervention Description
timolol maleate 0.25% and 0.5%
Primary Outcome Measure Information:
Title
Mean change from baseline in IOP
Time Frame
Up to Week 12
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Alcon Call Center
City
Fort Worth
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19683191
Citation
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.
Results Reference
result
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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
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