GlaucomaPhase 3NCT00061516
Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular Hypertension
A Phase 3 study testing BETAXON (levobetaxolol HCl) and AZOPT (brinzolamide) in people with Glaucoma and Ocular Hypertension, run by Alcon Research.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of both BETAXON and AZOPT 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. Read more about this study
- Who is it for?
- Ages 1 week to 5 years
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- BETAXON (levobetaxolol HCl) and AZOPT (brinzolamide)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Feb 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 5 years old and younger
- require treatment for glaucoma or ocular hypertension
- vision is 20/80 or better
- cup-to-disc ratio of 0.8 or less
Who cannot join
- do not have abnormal fixation
- IOP greater than 36 mm Hg
- significant retinal disease
- penetrating keratoplasty
- severe ocular pathology
- optic atrophy
Show all 9Show fewer
- eye surgery in the past 30 days
- cardiovascular abnormalities
- hypersensitivity to beta blockers, carbonic anhydrase inhibitors or sulfa drugs
About this study
The purpose of this study is to evaluate the safety and efficacy of both BETAXON and AZOPT 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.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- BETAXON (levobetaxolol HCl), AZOPT (brinzolamide)
- Keywords
- Glaucoma, Ocular Hypertension
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BETAXON (levobetaxolol HCl)Drug
levobetaxolol suspension, 0.5%
AZOPT (brinzolamide)Drug
brinzolamide suspension, 1%
| Study group | Role | What they receive |
|---|---|---|
| Brinzolamide suspension, 1% | Experimental | Dosed twice daily for 12 weeks Receives: Drug: AZOPT (brinzolamide) |
| Levobetaxolol suspension, 0.5% | Experimental | Dosed twice daily for 12 weeks Receives: Drug: BETAXON (levobetaxolol HCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change from Baseline IOP
Measured: Up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2003 (estimated)
- Study startJan 2003
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00061516
- Sponsor's protocol ID
- C-00-17
- Status last verified
- Aug 2008
- First submitted
- 28 May 2003
- Last updated
- 18 Nov 2016
- Results posted
- No
Publications
Whitson JT, Roarty JD, Vijaya L, Robin AL, Gross RD, Landry TA, Dickerson JE, Scheib SA, Scott H, Hua SY, Woodside AM, Bergamini MV; Brinzolamide Pediatric Study Group. Efficacy of brinzolamide and levobetaxolol in pediatric glaucomas: a randomized clinical trial. J AAPOS. 2008 Jun;12(3):239-246.e3. doi: 10.1016/j.jaapos.2007.11.004. Epub 2008 Mar 4.
PubMed 18289898
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00061516
- Acronym / sponsor ID
- C-00-17
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- Glaucoma, Ocular Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 30 May 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of both BETAXON and AZOPT 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brinzolamide suspension, 1% | Experimental | Drug: AZOPT (brinzolamide)Dosed twice daily for 12 weeks |
| Levobetaxolol suspension, 0.5% | Experimental | Drug: BETAXON (levobetaxolol HCl)Dosed twice daily for 12 weeks |
Who may qualify
- Ages
- 1 week to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children 5 years old and younger
- require treatment for glaucoma or ocular hypertension
- vision is 20/80 or better
- cup-to-disc ratio of 0.8 or less
Key exclusion criteria (9 listed)
- do not have abnormal fixation
- IOP greater than 36 mm Hg
- significant retinal disease
- penetrating keratoplasty
- severe ocular pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BETAXON (levobetaxolol HCl)levobetaxolol suspension, 0.5% | Drug | Levobetaxolol suspension, 0.5% |
| AZOPT (brinzolamide)brinzolamide suspension, 1% | Drug | Brinzolamide suspension, 1% |
Primary outcome
Mean Change from Baseline IOP
Time frame: Up to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2016.
- Results publication: PubMed 18289898Whitson JT, Roarty JD, Vijaya L, Robin AL, Gross RD, Landry TA, Dickerson JE, Scheib SA, Scott H, Hua SY, Woodside AM, Bergamini MV; Brinzolamide Pediatric Study Group. Efficacy of brinzolamide and levobetaxolol in pediatric glaucomas: a randomized clinical trial. J AAPOS. 2008 Jun;12(3):239-246.e3. doi: 10.1016/j.jaapos.2007.11.004. Epub 2008 Mar 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BETAXON (levobetaxolol HCl) and AZOPT (brinzolamide) in people with Glaucoma and Ocular Hypertension, run by Alcon Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change from Baseline IOP (time frame: Up to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00061516, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2016.