GlaucomaPhase 3NCT00061542
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
A Phase 3 study testing BETOPTIC S (betaxolol HCl) and Timolol Gel-forming Solution (TGFS) in people with Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 week to 5 years, men only
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- BETOPTIC S (betaxolol HCl) and Timolol Gel-forming Solution (TGFS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Nov 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
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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
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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- BETOPTIC S (betaxolol HCl), Timolol Gel-forming Solution (TGFS)
- 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.
BETOPTIC S (betaxolol HCl)Drug
betaxolol HC)
Timolol Gel-forming Solution (TGFS)Drug
timolol maleate 0.25% and 0.5%
| Study group | Role | What they receive |
|---|---|---|
| Betaxolol | Experimental | Two doses daily for 12 weeks Receives: Drug: BETOPTIC S (betaxolol HCl) |
| TGFS 0.25% | Experimental | Two doses daily for 12 weeks Receives: Drug: Timolol Gel-forming Solution (TGFS) |
| TGFS 0.5% | Experimental | Two doses daily for 12 weeks Receives: Drug: Timolol Gel-forming Solution (TGFS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in 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 completionNov 2006
- Study completionNov 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
- 105 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
- NCT00061542
- Sponsor's protocol ID
- C-01-01
- Status last verified
- Aug 2008
- First submitted
- 28 May 2003
- Last updated
- 18 Nov 2016
- Results posted
- No
Publications
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.
PubMed 19683191
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 BETOPTIC S 0.25% and Timolol Gel-forming Solution 0.25% and 0.5% in Pediatric Patients With Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00061542
- Acronym / sponsor ID
- C-01-01
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- Glaucoma, Ocular Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Betaxolol | Experimental | Drug: BETOPTIC S (betaxolol HCl)Two doses daily for 12 weeks |
| TGFS 0.25% | Experimental | Drug: Timolol Gel-forming Solution (TGFS)Two doses daily for 12 weeks |
| TGFS 0.5% | Experimental | Drug: Timolol Gel-forming Solution (TGFS)Two doses daily for 12 weeks |
Who may qualify
- Ages
- 1 week to 5 years
- Sex
- Male only
- 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
- whose vision is 20/80 or better
- have a 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 |
|---|---|---|
| BETOPTIC S (betaxolol HCl)betaxolol HC) | Drug | Betaxolol |
| Timolol Gel-forming Solution (TGFS)timolol maleate 0.25% and 0.5% | Drug | TGFS 0.25%, TGFS 0.5% |
Primary outcome
Mean change from baseline in 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 19683191Plager 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BETOPTIC S (betaxolol HCl) and Timolol Gel-forming Solution (TGFS) in people with Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in United States.
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.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 in 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 NCT00061542, 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.