Open-angle GlaucomaPhase 3NCT00314158
A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
A Phase 3 study testing Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension, Brinzolamide 10 mg/ml (AZOPT) eye drops, suspension and Timolol 5 mg/ml eye drops, solution in people with Open-angle Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-angle Glaucoma, Ocular Hypertension
- What is being tested?
- Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension, Brinzolamide 10 mg/ml (AZOPT) eye drops, suspension and Timolol 5 mg/ml eye drops, solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 523 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Jan 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Diagnosis of open-angle glaucoma
- Other protocol-defined inclusion criteria may apply
Who cannot join
- Under 18
- Pregnant
- Other protocol-defined exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
United States Investigative Sites
Fort Worth, Texas, 76134
About this study
The purpose of this study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension.
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Being tested
- Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension, Brinzolamide 10 mg/ml (AZOPT) eye drops, suspension, Timolol 5 mg/ml eye drops, solution
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspensionDrug
One drop twice daily in each study eye for six months
Brinzolamide 10 mg/ml (AZOPT) eye drops, suspensionDrug
Also called AZOPT
One drop twice daily in each study eye for six months
Timolol 5 mg/ml eye drops, solutionDrug
One drop twice daily in each study eye for six months
| Study group | Role | What they receive |
|---|---|---|
| Brinzolamide +Timolol | Experimental | Not described Receives: Drug: Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension |
| Brinzolamide | Active comparator | Not described Receives: Drug: Brinzolamide 10 mg/ml (AZOPT) eye drops, suspension |
| Timolol | Active comparator | Not described Receives: Drug: Timolol 5 mg/ml eye drops, solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean intra-ocular pressure (IOP)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2006 (estimated)
- Study startNov 2005
- Primary completionJan 2007
- Study completionJan 2007
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 Open-angle 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
- Who is masked
- Participant, Investigator
- Enrolment
- 523 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
- NCT00314158
- Sponsor's protocol ID
- C-05-24
- Status last verified
- Mar 2012
- First submitted
- 10 Apr 2006
- Last updated
- 18 Nov 2016
- Results posted
- No
Publications
Kaback M, Scoper SV, Arzeno G, James JE, Hua SY, Salem C, Dickerson JE, Landry TA, Bergamini MV; Brinzolamide 1%/Timolol 0.5% Study Group. Intraocular pressure-lowering efficacy of brinzolamide 1%/timolol 0.5% fixed combination compared with brinzolamide 1% and timolol 0.5%. Ophthalmology. 2008 Oct;115(10):1728-34, 1734.e1-2. doi: 10.1016/j.ophtha.2008.04.011. Epub 2008 Jun 5.
PubMed 18538406
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
- A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00314158
- Acronym / sponsor ID
- C-05-24
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 523 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 13 Apr 2006 (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 determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brinzolamide +Timolol | Experimental | Drug: Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension |
| Brinzolamide | Active comparator | Drug: Brinzolamide 10 mg/ml (AZOPT) eye drops, suspension |
| Timolol | Active comparator | Drug: Timolol 5 mg/ml eye drops, solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Diagnosis of open-angle glaucoma
- Other protocol-defined inclusion criteria may apply
Key exclusion criteria (3 listed)
- Under 18
- Pregnant
- Other protocol-defined exclusion criteria may apply
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 |
|---|---|---|
| Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspensionOne drop twice daily in each study eye for six months | Drug | Brinzolamide +Timolol |
| Brinzolamide 10 mg/ml (AZOPT) eye drops, suspensionAlso: AZOPTOne drop twice daily in each study eye for six months | Drug | Brinzolamide |
| Timolol 5 mg/ml eye drops, solutionOne drop twice daily in each study eye for six months | Drug | Timolol |
Primary outcome
Mean intra-ocular pressure (IOP)
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 18538406Kaback M, Scoper SV, Arzeno G, James JE, Hua SY, Salem C, Dickerson JE, Landry TA, Bergamini MV; Brinzolamide 1%/Timolol 0.5% Study Group. Intraocular pressure-lowering efficacy of brinzolamide 1%/timolol 0.5% fixed combination compared with brinzolamide 1% and timolol 0.5%. Ophthalmology. 2008 Oct;115(10):1728-34, 1734.e1-2. doi: 10.1016/j.ophtha.2008.04.011. Epub 2008 Jun 5.
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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 Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension, Brinzolamide 10 mg/ml (AZOPT) eye drops, suspension and Timolol 5 mg/ml eye drops, solution in people with Open-angle 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 3 inclusion and 3 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 intra-ocular pressure (IOP). 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 NCT00314158, 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.