Open-Angle GlaucomaPhase 4NCT00822055
Comparison of the Fixed Combinations of Brimonidine/Timolol and Dorzolamide/Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension
A Phase 4 study testing brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination, dorzolamide hcl 2%/timolol maleate 0.5% fixed combination and brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy in people with Open-Angle Glaucoma and Ocular Hypertension, run by Allergan at 1 site in Canada.
Trial summary
This study compares the efficacy and tolerability/comfort of brimonidine/timolol and dorzolamide/timolol in patients with open-angle glaucoma or ocular hypertension. In an investigator masked randomisation process, each subject is allocated to received either brimonidine/timolol or dorzolamide/timolol as… 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?
- brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination, dorzolamide hcl 2%/timolol maleate 0.5% fixed combination and brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- May 2005to Nov 2006
- 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
- Male or female over 18 years
- Female subjects of childbearing potential must have negative pregnancy test and practice contraception
- Subjects must have confirmed diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes
- Subjects who are or have been insufficiently responsive to IOP reducing monotherapy and use of either study medication is deemed appropriate
- Subjects able to complete questionnaires and provide informed consent
Who cannot join
- Female subjects who are pregnant, planning to become pregnant during study period, breast feeding or not practicing a reliable method of birth control
- Subjects wherein the study drugs are contraindicated
- Subjects who have had intraocular surgery with 6 months (3 months for laser)
- Subjects with known side effects/allergy or sensitivity to any component of study treatments
- Subjects with any uncontrolled systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
This study compares the efficacy and tolerability/comfort of brimonidine/timolol and dorzolamide/timolol in patients with open-angle glaucoma or ocular hypertension. In an investigator masked randomisation process, each subject is allocated to received either brimonidine/timolol or dorzolamide/timolol as fixed-combination monotherapy or as an adjunctive to a prostaglandin analogue for a period of 12 weeks. After screening, patient returns at baseline, Month 1 and Month 3 for ophthalmic evaluations.
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Being tested
- brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination, dorzolamide hcl 2%/timolol maleate 0.5% fixed combination, brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy, dorzolamide hcl 2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy
- 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.
brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combinationDrug
Also called Combigan®
1 drop BID in each eye
dorzolamide hcl 2%/timolol maleate 0.5% fixed combinationDrug
Also called Cosopt®
1 drop BID in each eye
brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapyDrug
Also called Combigan®
1 drop BID in each eye
dorzolamide hcl 2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapyDrug
Also called Cosopt®
1 drop BID in each eye
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | brimonidine/timolol Fixed-combination monotherapy Receives: Drug: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination |
| 2 | Active comparator | dorzolamide/timolol fixed-combination monotherapy Receives: Drug: dorzolamide hcl 2%/timolol maleate 0.5% fixed combination |
| 3 | Active comparator | prostaglandin analogue + brimonidine/timolol fixed combination Receives: Drug: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy |
| 4 | Active comparator | prostaglandin analogue + dorzolamide/timolol fixed combination Receives: Drug: dorzolamide hcl 2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean IOP
Measured: 12 weeks
Secondary outcomes (1)
Patient tolerability/comfort measured by Likert scale
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startMay 2005
- Primary completionNov 2006
- Study completionNov 2006
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.
- 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
- 140 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
- NCT00822055
- Sponsor's protocol ID
- COM0501
- Status last verified
- Jan 2009
- First submitted
- 13 Jan 2009
- Last updated
- 14 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Nixon DR, Yan DB, Chartrand JP, Piemontesi RL, Simonyi S, Hollander DA. Three-month, randomized, parallel-group comparison of brimonidine-timolol versus dorzolamide-timolol fixed-combination therapy. Curr Med Res Opin. 2009 Jul;25(7):1645-53. doi: 10.1185/03007990902994041.
PubMed 19476406
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Fixed Combinations of Brimonidine/Timolol and Dorzolamide/Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00822055
- Acronym / sponsor ID
- COM0501
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 14 Jan 2009 (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 compares the efficacy and tolerability/comfort of brimonidine/timolol and dorzolamide/timolol in patients with open-angle glaucoma or ocular hypertension. In an investigator masked randomisation process, each subject is allocated to received either brimonidine/timolol or dorzolamide/timolol as fixed-combination monotherapy or as an adjunctive to a prostaglandin analogue for a period of 12 weeks. After screening, patient returns at baseline, Month 1 and Month 3 for ophthalmic evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combinationbrimonidine/timolol Fixed-combination monotherapy |
| 2 | Active comparator | Drug: dorzolamide hcl 2%/timolol maleate 0.5% fixed combinationdorzolamide/timolol fixed-combination monotherapy |
| 3 | Active comparator | Drug: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapyprostaglandin analogue + brimonidine/timolol fixed combination |
| 4 | Active comparator | Drug: dorzolamide hcl 2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapyprostaglandin analogue + dorzolamide/timolol fixed combination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female over 18 years
- Female subjects of childbearing potential must have negative pregnancy test and practice contraception
- Subjects must have confirmed diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes
- Subjects who are or have been insufficiently responsive to IOP reducing monotherapy and use of either study medication is deemed appropriate
- Subjects able to complete questionnaires and provide informed consent
Key exclusion criteria (5 listed)
- Female subjects who are pregnant, planning to become pregnant during study period, breast feeding or not practicing a reliable method of birth control
- Subjects wherein the study drugs are contraindicated
- Subjects who have had intraocular surgery with 6 months (3 months for laser)
- Subjects with known side effects/allergy or sensitivity to any component of study treatments
- Subjects with any uncontrolled systemic disease
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 tartrate 0.2%/timolol maleate 0.5% fixed combinationAlso: Combigan®1 drop BID in each eye | Drug | 1 |
| dorzolamide hcl 2%/timolol maleate 0.5% fixed combinationAlso: Cosopt®1 drop BID in each eye | Drug | 2 |
| brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapyAlso: Combigan®1 drop BID in each eye | Drug | 3 |
| dorzolamide hcl 2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapyAlso: Cosopt®1 drop BID in each eye | Drug | 4 |
Primary outcome
Change from baseline in mean IOP
Time frame: 12 weeks
1 secondary outcome
Patient tolerability/comfort measured by Likert scale
Time frame: Month 1
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 14 Jan 2009.
- Derived from this study: PubMed 19476406Nixon DR, Yan DB, Chartrand JP, Piemontesi RL, Simonyi S, Hollander DA. Three-month, randomized, parallel-group comparison of brimonidine-timolol versus dorzolamide-timolol fixed-combination therapy. Curr Med Res Opin. 2009 Jul;25(7):1645-53. doi: 10.1185/03007990902994041.
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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 4 study testing brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination, dorzolamide hcl 2%/timolol maleate 0.5% fixed combination and brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy in people with Open-Angle Glaucoma and Ocular Hypertension, run by Allergan at 1 site in Canada.
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 5 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 14 Jan 2009. 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 Canada. 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?
Change from baseline in mean IOP (time frame: 12 weeks). 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 NCT00822055, 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 14 Jan 2009.