GlaucomaPhase 3NCT00651612
Study to Evaluate Safety of Brimonidine/Timolol Fixed Combination in Glaucoma or Ocular Hypertension Patients
A Phase 3 study testing Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution and Concurrent brimonidine 0.2% and 0.5% timolol in people with Glaucoma and Ocular Hypertension, run by Allergan at 1 site in United States.
Trial summary
This study evaluates the safety of brimonidine/timolol fixed combination in glaucoma or ocular hypertension patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution and Concurrent brimonidine 0.2% and 0.5% timolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 604 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
- Diagnosis of ocular hypertension or glaucoma
- Patient requires IOP-lowering therapy in both eyes
Who cannot join
- Uncontrolled medical conditions
- Contraindication to β-adrenoceptor antagonist therapy or brimonidine therapy
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the safety of brimonidine/timolol fixed combination in glaucoma or ocular hypertension patients
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution, Concurrent brimonidine 0.2% and 0.5% timolol
- 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.
Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic SolutionDrug
Also called COMBIGAN™
Brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution 1 drop instilled in each eye two times daily (morning and evening)
Concurrent brimonidine 0.2% and 0.5% timololDrug
Brimonidine 0.2%, 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and timolol 0.5% timolol, 1 drop instilled in each eye twice daily (morning and evening) and vehicle of brimonidine combination ophthalmic solution 1 drop instilled in each eye (morning, afternoon and/or evening)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution Receives: Drug: Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution |
| 2 | Active comparator | Concurrent Brimonidine 0.2% and 0.5% Timolol Receives: Drug: Concurrent brimonidine 0.2% and 0.5% timolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (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.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- 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
- 604 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00651612
- Sponsor's protocol ID
- 190342-024T
- Status last verified
- Apr 2008
- First submitted
- 1 Apr 2008
- Last updated
- 3 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate Safety of Brimonidine/Timolol Fixed Combination in Glaucoma or Ocular Hypertension Patients
- ClinicalTrials.gov ID
- NCT00651612
- Acronym / sponsor ID
- 190342-024T
- Conditions
- Glaucoma, Ocular Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 604 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 3 Apr 2008 (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.
This study evaluates the safety of brimonidine/timolol fixed combination in glaucoma or ocular hypertension patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic SolutionBrimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution |
| 2 | Active comparator | Drug: Concurrent brimonidine 0.2% and 0.5% timololConcurrent Brimonidine 0.2% and 0.5% Timolol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of ocular hypertension or glaucoma
- Patient requires IOP-lowering therapy in both eyes
Key exclusion criteria (2 listed)
- Uncontrolled medical conditions
- Contraindication to β-adrenoceptor antagonist therapy or brimonidine therapy
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 |
|---|---|---|
| Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic SolutionAlso: COMBIGAN™Brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution 1 drop instilled in each eye two times daily (morning and evening) | Drug | 1 |
| Concurrent brimonidine 0.2% and 0.5% timololBrimonidine 0.2%, 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and timolol 0.5% timolol, 1 drop instilled in each eye twice daily (morning and evening) and vehicle of brimonidine combination ophthalmic solution 1 drop instilled in each eye (morning, afternoon and/or evening) | Drug | 2 |
Primary outcome
Adverse Events
Time frame: Day 10
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 3 Apr 2008.
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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.
Medical Director study director
Allergan
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 Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution and Concurrent brimonidine 0.2% and 0.5% timolol in people with Glaucoma and Ocular Hypertension, run by Allergan 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 2 inclusion and 2 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 3 Apr 2008. 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?
Adverse Events (time frame: Day 10). 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 3 Apr 2008.