Primary Open Angle GlaucomaPhase 4NCT00675207
Comparison of Brimonidine Purite, Dorzolamide, and Brinzolamide as Adjunctive Therapy to Prostaglandin Analogs
A Phase 4 study testing Brimonidine purite 0.15%, Dorzolamide 2% and Brinzolamide 1% in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Northwestern Ophthalmic Institute S.C. at 1 site in United States.
Trial summary
The purpose of this study is to compare the efficacy of brimonidine Purite, dorzolamide, and brinzolamide in reducing intraocular pressure when added to prostaglandin analog therapy (bimatoprost, latanoprost, or travoprost) in patients with glaucoma or ocular hypertension. Read more about this study
- Who is it for?
- Ages 41 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Brimonidine purite 0.15%, Dorzolamide 2% and Brinzolamide 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jul 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 41 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of primary open-angle glaucoma or ocular hypertension.
- Must be over 40 years of age.
- Intraocular pressure must be 18 mm Hg or higher after 6 weeks of treatment (run-in) with a prostaglandin analog (bimatoprost, latanoprost, or travoprost).
Who cannot join
- History of angle closure or narrow angle.
- Previous intraocular surgery.
- Laser trabeculoplasty within 3 months prior to screening.
- History of uveitis or intraocular inflammation.
- Use of medications other than the study medications that are known to affect IOP (e.g., beta-blockers, steroids, or angiotensin II blockers) within 3 months of study entry or during the study.
- Intolerance of or hypersensitivity to prostaglandin analogs, sulfonamides, alpha-agonists, or the preservative benzalkonium chloride.
- Women of childbearing age who are pregnant or not using contraception.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Ophthalmic Institute S.C.
Glenview, Illinois, 60026
About this study
Official title: Comparison of Brimonidine 0.15% Purite, Dorzolamide 2%, and Brinzolamide 1% as Adjunctive Therapy to Prostaglandin Analogs
The purpose of this study is to compare the efficacy of brimonidine Purite, dorzolamide, and brinzolamide in reducing intraocular pressure when added to prostaglandin analog therapy (bimatoprost, latanoprost, or travoprost) in patients with glaucoma or ocular hypertension.
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Being tested
- Brimonidine purite 0.15%, Dorzolamide 2%, Brinzolamide 1%
- Keywords
- glaucoma, ocular hypertension, adjunctive treatment, prostaglandin, prostaglandin analog, brimonidine, dorzolamide, brinzolamide, alpha agonist, carbonic anhydrase inhibitor, intraocular pressure
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brimonidine purite 0.15%Drug
Also called Alphagan P 0.15%
A single drop of brimonidine purite 0.15% ophthalmic solution administered topically in the eye 3 times daily.
Dorzolamide 2%Drug
Also called Trusopt
A single drop of dorzolamide 2% ophthalmic solution administered topically in the eye 3 times daily.
Brinzolamide 1%Drug
Also called Azopt
A single drop of brinzolamide 1% ophthalmic solution administered topically in the eye 3 times daily.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Brimonidine purite 0.15% Receives: Drug: Brimonidine purite 0.15% |
| 2 | Active comparator | Dorzolamide 2% Receives: Drug: Dorzolamide 2% |
| 3 | Active comparator | Brinzolamide 1% Receives: Drug: Brinzolamide 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
Measured: Measurements at peak and trough effect (10 am and 4 pm) at baseline, month 1, and month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2008 (estimated)
- Study startJan 2006
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern Ophthalmic Institute S.C.
- Sponsor type
- University, hospital or other
- Collaborators
- Research to Prevent Blindness
- Investigators
- Thomas E. Bournias, MD, Principal investigator, Northwestern Ophthalmic Institute S.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675207
- Sponsor's protocol ID
- NWOIADJ 2006
- Status last verified
- May 2008
- First submitted
- 6 May 2008
- Last updated
- 8 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Brimonidine 0.15% Purite, Dorzolamide 2%, and Brinzolamide 1% as Adjunctive Therapy to Prostaglandin Analogs
- ClinicalTrials.gov ID
- NCT00675207
- Acronym / sponsor ID
- NWOIADJ 2006
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Keywords
- glaucoma, ocular hypertension, adjunctive treatment, prostaglandin, prostaglandin analog, brimonidine, dorzolamide, brinzolamide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Northwestern Ophthalmic Institute S.C.University, hospital or other
- Collaborators
- Research to Prevent Blindness
- Study start
- Jan 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 8 May 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.
The purpose of this study is to compare the efficacy of brimonidine Purite, dorzolamide, and brinzolamide in reducing intraocular pressure when added to prostaglandin analog therapy (bimatoprost, latanoprost, or travoprost) in patients with glaucoma or ocular hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Brimonidine purite 0.15%Brimonidine purite 0.15% |
| 2 | Active comparator | Drug: Dorzolamide 2%Dorzolamide 2% |
| 3 | Active comparator | Drug: Brinzolamide 1%Brinzolamide 1% |
Who may qualify
- Ages
- 41 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of primary open-angle glaucoma or ocular hypertension.
- Must be over 40 years of age.
- Intraocular pressure must be 18 mm Hg or higher after 6 weeks of treatment (run-in) with a prostaglandin analog (bimatoprost, latanoprost, or travoprost).
Key exclusion criteria (7 listed)
- History of angle closure or narrow angle.
- Previous intraocular surgery.
- Laser trabeculoplasty within 3 months prior to screening.
- History of uveitis or intraocular inflammation.
- Use of medications other than the study medications that are known to affect IOP (e.g., beta-blockers, steroids, or angiotensin II blockers) within 3 months of study entry or during the study.
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 purite 0.15%Also: Alphagan P 0.15%A single drop of brimonidine purite 0.15% ophthalmic solution administered topically in the eye 3 times daily. | Drug | 1 |
| Dorzolamide 2%Also: TrusoptA single drop of dorzolamide 2% ophthalmic solution administered topically in the eye 3 times daily. | Drug | 2 |
| Brinzolamide 1%Also: AzoptA single drop of brinzolamide 1% ophthalmic solution administered topically in the eye 3 times daily. | Drug | 3 |
Primary outcome
Intraocular pressure
Time frame: Measurements at peak and trough effect (10 am and 4 pm) at baseline, month 1, and month 4
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 8 May 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.
Thomas E. Bournias, MD principal investigator
Northwestern Ophthalmic Institute S.C.
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 Brimonidine purite 0.15%, Dorzolamide 2% and Brinzolamide 1% in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Northwestern Ophthalmic Institute S.C. 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 7 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 May 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?
Intraocular pressure (time frame: Measurements at peak and trough effect (10 am and 4 pm) at baseline, month 1, and month 4). 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 May 2008.