GlaucomaPhase 4NCT00440141
Brimonidine 0.1% Versus Brinzolamide 1% as Adjunctive Therapy to Latanoprost 0.005%
A Phase 4 study testing latanoprost 0.005% eye drops and brimonidine 0.1% eye drops and latanoprost 0.005% eye drops and brinzolamide 1.0% eye drops in people with Glaucoma and Ocular Hypertension, run by Allergan at 1 site in United States.
Trial summary
Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering will be randomized to receive either brimonidine 0.1% or brinzolamide 1% three-times daily as adjunctive therapy to latanoprost 0.005% 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?
- latanoprost 0.005% eye drops and brimonidine 0.1% eye drops and latanoprost 0.005% eye drops and brinzolamide 1.0% eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Mar 2007
- Phase
- Phase 4
- 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
- Glaucoma or ocular hypertension in both eyes
- Currently being treated with latanoprost 0.005% QD
- IOP greater than or equal to 18mm Hg on latanoprost 0.005%
- Best-corrected VA of 20/200 or better in each eye
- Visual field within 6 months of study entry
Who cannot join
- Secondary glaucoma
- Active intraocular inflammation or macular edema
- Intraocular surgery or laser surgery within the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering will be randomized to receive either brimonidine 0.1% or brinzolamide 1% three-times daily as adjunctive therapy to latanoprost 0.005%
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- latanoprost 0.005% eye drops and brimonidine 0.1% eye drops, latanoprost 0.005% eye drops and brinzolamide 1.0% eye drops
- 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.
latanoprost 0.005% eye drops and brimonidine 0.1% eye dropsDrug
Also called Xalatan®, Alphagan® P
latanoprost 0.005%, 1 drop nightly for 3 months and brimonidine 0.1% three-times daily for 3 months
latanoprost 0.005% eye drops and brinzolamide 1.0% eye dropsDrug
Also called Xalatan®, Azopt®
latanoprost 0.005% 1 drop nightly for 3 months AND brinzolamide 1.0% 1% three-times daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: latanoprost 0.005% eye drops and brimonidine 0.1% eye drops |
| 2 | Active comparator | Not described Receives: Drug: latanoprost 0.005% eye drops and brinzolamide 1.0% eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP
Measured: Month 3
Secondary outcomes (1)
Tolerability
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2007 (estimated)
- Study startJul 2006
- Primary completionMar 2007
- Study completionMar 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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Affairs, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440141
- Sponsor's protocol ID
- MA-AP01
- Status last verified
- Dec 2007
- First submitted
- 22 Feb 2007
- Last updated
- 2 Jan 2008
- Results posted
- No
Publications
Day DG, Hollander DA. Brimonidine purite 0.1% versus brinzolamide 1% as adjunctive therapy to latanoprost in patients with glaucoma or ocular hypertension. Curr Med Res Opin. 2008 May;24(5):1435-42. doi: 10.1185/030079908x301848. Epub 2008 Apr 9.
PubMed 18402717
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brimonidine 0.1% Versus Brinzolamide 1% as Adjunctive Therapy to Latanoprost 0.005%
- ClinicalTrials.gov ID
- NCT00440141
- Acronym / sponsor ID
- MA-AP01
- Conditions
- Glaucoma, Ocular Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 26 Feb 2007 (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.
Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering will be randomized to receive either brimonidine 0.1% or brinzolamide 1% three-times daily as adjunctive therapy to latanoprost 0.005%
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: latanoprost 0.005% eye drops and brimonidine 0.1% eye drops |
| 2 | Active comparator | Drug: latanoprost 0.005% eye drops and brinzolamide 1.0% eye drops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Glaucoma or ocular hypertension in both eyes
- Currently being treated with latanoprost 0.005% QD
- IOP greater than or equal to 18mm Hg on latanoprost 0.005%
- Best-corrected VA of 20/200 or better in each eye
- Visual field within 6 months of study entry
Key exclusion criteria (3 listed)
- Secondary glaucoma
- Active intraocular inflammation or macular edema
- Intraocular surgery or laser surgery within the past 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 |
|---|---|---|
| latanoprost 0.005% eye drops and brimonidine 0.1% eye dropsAlso: Xalatan®, Alphagan® Platanoprost 0.005%, 1 drop nightly for 3 months and brimonidine 0.1% three-times daily for 3 months | Drug | 1 |
| latanoprost 0.005% eye drops and brinzolamide 1.0% eye dropsAlso: Xalatan®, Azopt®latanoprost 0.005% 1 drop nightly for 3 months AND brinzolamide 1.0% 1% three-times daily for 3 months | Drug | 2 |
Primary outcome
IOP
Time frame: Month 3
1 secondary outcome
Tolerability
Time frame: Month 3
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 2 Jan 2008.
- Derived from this study: PubMed 18402717Day DG, Hollander DA. Brimonidine purite 0.1% versus brinzolamide 1% as adjunctive therapy to latanoprost in patients with glaucoma or ocular hypertension. Curr Med Res Opin. 2008 May;24(5):1435-42. doi: 10.1185/030079908x301848. Epub 2008 Apr 9.
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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 Affairs 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 4 study testing latanoprost 0.005% eye drops and brimonidine 0.1% eye drops and latanoprost 0.005% eye drops and brinzolamide 1.0% eye drops 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 5 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 2 Jan 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
IOP (time frame: Month 3). 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 NCT00440141, 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 2 Jan 2008.