Open-angle GlaucomaPhase 3NCT00314171
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 and Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (COSOPT) in people with Open-angle Glaucoma and Ocular Hypertension, run by Alcon Research.
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 and Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (COSOPT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 437 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Aug 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 or older
- Diagnosis of open-angle glaucoma or ocular hypertension
- Other protocol-defined inclusion criteria may apply
Who cannot join
- Under 18
- Pregnant
- Other protocol-defined exclusion criteria may apply
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, Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (COSOPT)
- Keywords
- open-angle glaucoma, ocular hypertension
- 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 in the study eye(s) twice daily for 12 months
Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (COSOPT)Drug
Also called COSOPT
One drop in the study eye(s) twice daily for 12 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 |
| Dorzolamide + Timolol | Active comparator | Not described Receives: Drug: Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (COSOPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean IOP
Secondary outcomes (1)
Percent patients with IOP < 18 mmHg
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 startOct 2005
- Primary completionAug 2007
- Study completionAug 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
- 437 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
- NCT00314171
- Sponsor's protocol ID
- C-05-10
- Status last verified
- Mar 2012
- First submitted
- 10 Apr 2006
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Manni G, Denis P, Chew P, Sharpe ED, Orengo-Nania S, Coote MA, Laganovska G, Volksone L, Zeyen T, Filatori I, James J, Aung T. The safety and efficacy of brinzolamide 1%/timolol 0.5% fixed combination versus dorzolamide 2%/timolol 0.5% in patients with open-angle glaucoma or ocular hypertension. J Glaucoma. 2009 Apr-May;18(4):293-300. doi: 10.1097/IJG.0b013e31818fb434.
PubMed 19365194
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
- NCT00314171
- Acronym / sponsor ID
- C-05-10
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Keywords
- open-angle glaucoma, ocular hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 437 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Brinzolamide + Timolol | Experimental | Drug: Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension |
| Dorzolamide + Timolol | Active comparator | Drug: Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (COSOPT) |
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 or older
- Diagnosis of open-angle glaucoma or ocular hypertension
- 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 in the study eye(s) twice daily for 12 months | Drug | Brinzolamide + Timolol |
| Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (COSOPT)Also: COSOPTOne drop in the study eye(s) twice daily for 12 months | Drug | Dorzolamide + Timolol |
Primary outcome
Mean IOP
1 secondary outcome
Percent patients with IOP < 18 mmHg
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 19365194Manni G, Denis P, Chew P, Sharpe ED, Orengo-Nania S, Coote MA, Laganovska G, Volksone L, Zeyen T, Filatori I, James J, Aung T. The safety and efficacy of brinzolamide 1%/timolol 0.5% fixed combination versus dorzolamide 2%/timolol 0.5% in patients with open-angle glaucoma or ocular hypertension. J Glaucoma. 2009 Apr-May;18(4):293-300. doi: 10.1097/IJG.0b013e31818fb434.
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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 Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension and Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (COSOPT) in people with Open-angle 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 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.
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 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 NCT00314171, 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.