Open-Angle GlaucomaPhase 2NCT01426867
A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2%
A Phase 2 study testing Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, Brinzolamide ophthalmic suspension, 1% and Brimonidine tartrate ophthalmic solution, 0.2% in people with Open-Angle Glaucoma and Ocular Hypertension, run by Alcon Research.
Trial summary
The purpose of this study was to describe the ocular discomfort immediately upon instillation of Brinzolamide 1%/Brimonidine 0.2% Tartrate Ophthalmic Suspension, Brinzolamide 1% Ophthalmic Suspension, and Brimonidine Tartrate 0.2% Ophthalmic Solution in subjects with open-angle glaucoma and/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 1%/brimonidine tartrate 0.2% ophthalmic suspension, Brinzolamide ophthalmic suspension, 1% and Brimonidine tartrate ophthalmic solution, 0.2%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Nov 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Sign Informed Consent document.
- Diagnosis of open-angle glaucoma or ocular hypertension
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
- Severe central vision loss in either eye.
- Any chronic or recurrent inflammatory eye disease.
- Ocular trauma within the preceding 6 months.
- Ocular infection or ocular inflammation within the preceding 3 months.
- Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.
Show all 10Show fewer
- Any intraocular surgery within the preceding 6 months.
- Any ocular laser surgery within the preceding 3 months.
- History or current evidence of severe illness or any other conditions which would make the subject, in the opinion of the Investigator, unsuitable for the study.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: A Descriptive Comfort Study of Brinzolamide 1% / Brimonidine Tartrate 0.2% Fixed Combination Ophthalmic Suspension, Brinzolamide 1% Ophthalmic Suspension and Brimonidine Tartrate 0.2% Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
The purpose of this study was to describe the ocular discomfort immediately upon instillation of Brinzolamide 1%/Brimonidine 0.2% Tartrate Ophthalmic Suspension, Brinzolamide 1% Ophthalmic Suspension, and Brimonidine Tartrate 0.2% Ophthalmic Solution in subjects with open-angle glaucoma and/or ocular hypertension.
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Being tested
- Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, Brinzolamide ophthalmic suspension, 1%, Brimonidine tartrate ophthalmic solution, 0.2%
- Keywords
- Open-Angle Glaucoma, Ocular Hypertension, Intraocular Pressure, Brinzolamide, Brimonidine
- 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 1%/brimonidine tartrate 0.2% ophthalmic suspensionDrug
Brinzolamide ophthalmic suspension, 1%Drug
Brimonidine tartrate ophthalmic solution, 0.2%Drug
| Study group | Role | What they receive |
|---|---|---|
| Brinz/Brim | Experimental | Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days Receives: Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension |
| Brinzolamide | Active comparator | Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days Receives: Drug: Brinzolamide ophthalmic suspension, 1% |
| Brimonidine | Active comparator | Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days Receives: Drug: Brimonidine tartrate ophthalmic solution, 0.2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Ocular Discomfort Score
Ocular discomfort was assessed by the subject immediately following the 8 AM instillation of study drug and rated on a 5-point scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe).
Measured: Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ravaughn Williams, OD, MS, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426867
- Sponsor's protocol ID
- C-11-002
- Status last verified
- May 2013
- First submitted
- 24 Aug 2011
- Last updated
- 8 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Descriptive Comfort Study of Brinzolamide 1% / Brimonidine Tartrate 0.2% Fixed Combination Ophthalmic Suspension, Brinzolamide 1% Ophthalmic Suspension and Brimonidine Tartrate 0.2% Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT01426867
- Acronym / sponsor ID
- C-11-002
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Keywords
- Open-Angle Glaucoma, Ocular Hypertension, Intraocular Pressure, Brinzolamide, Brimonidine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 1 Sep 2011 (estimated)
- Results
- Posted 8 Jul 2013
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 was to describe the ocular discomfort immediately upon instillation of Brinzolamide 1%/Brimonidine 0.2% Tartrate Ophthalmic Suspension, Brinzolamide 1% Ophthalmic Suspension, and Brimonidine Tartrate 0.2% Ophthalmic Solution in subjects with open-angle glaucoma and/or ocular hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brinz/Brim | Experimental | Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspensionBrinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days |
| Brinzolamide | Active comparator | Drug: Brinzolamide ophthalmic suspension, 1%Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days |
| Brimonidine | Active comparator | Drug: Brimonidine tartrate ophthalmic solution, 0.2%Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sign Informed Consent document.
- Diagnosis of open-angle glaucoma or ocular hypertension
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (10 listed)
- Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
- Severe central vision loss in either eye.
- Any chronic or recurrent inflammatory eye disease.
- Ocular trauma within the preceding 6 months.
- Ocular infection or ocular inflammation within the preceding 3 months.
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 1%/brimonidine tartrate 0.2% ophthalmic suspension | Drug | Brinz/Brim |
| Brinzolamide ophthalmic suspension, 1% | Drug | Brinzolamide |
| Brimonidine tartrate ophthalmic solution, 0.2% | Drug | Brimonidine |
Primary outcome
Mean Ocular Discomfort Score
Time frame: Week 1
Ocular discomfort was assessed by the subject immediately following the 8 AM instillation of study drug and rated on a 5-point scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ravaughn Williams, OD, MS study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, Brinzolamide ophthalmic suspension, 1% and Brimonidine tartrate ophthalmic solution, 0.2% 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 10 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 8 Jul 2013. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Ocular Discomfort Score (time frame: Week 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2013.