GlaucomaPhase 4NCT01471158
Patient Preference Comparison of AZARGA Versus COSOPT in Patients With Glaucoma
A Phase 4 study testing Brinzolamide/Timolol Maleate Fixed Combination (AZARGA) and Dorzolamide/timolol Maleate Fixed Combination (COSOPT) in people with Glaucoma, run by Alcon Research at 1 site in Argentina.
Trial summary
The purpose of this study is to assess patient preference of AZARGA® compared to COSOPT® after a single drop of each medication is administered to both eyes, in patients with open-angled glaucoma or ocular hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Brinzolamide/Timolol Maleate Fixed Combination (AZARGA) and Dorzolamide/timolol Maleate Fixed Combination (COSOPT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteArgentina
- Study dates
- Sep 2010to May 2011
- 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
- Clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
- On a stable regimen intraocular pressure (IOP) lowering medication within 30 days of screening visit.
- IOP considered to be safe (in the opinion of the investigator) in both eyes in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
- Willing to discontinue use of all other ocular drugs (prescribed and over-the-counter) prior to receiving the screening dose during Screening Visit and for the course of the study.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in this study that is deemed clinical significant in the opinion of the Principal Investigator.
- Corneal dystrophies in either eye.
- Risk of visual field or visual acuity worsening as a consequence of participating in this study, in the investigator's best judgment.
- Bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
- History of severe allergic rhinitis.
- Participation in any other investigational study within 30 days prior to the Screening/Baseline Visit.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Preference Comparison of AZARGA Versus COSOPT After Single Doses in Patients With Open-Angled Glaucoma or Ocular Hypertension
The purpose of this study is to assess patient preference of AZARGA® compared to COSOPT® after a single drop of each medication is administered to both eyes, in patients with open-angled glaucoma or ocular hypertension.
- Conditions
- Glaucoma
- Being tested
- Brinzolamide/Timolol Maleate Fixed Combination (AZARGA), Dorzolamide/timolol Maleate Fixed Combination (COSOPT)
- Keywords
- Primary open-angle glaucoma, ocular hypertension, pigment dispersion glaucoma
- Medical subject headings
- Glaucoma, 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/Timolol Maleate Fixed Combination (AZARGA)Drug
Also called AZARGA®
Brinzolamide/timolol maleate fixed combination, one drop instilled in one eye at baseline, followed by one drop instilled in each eye once in either first intervention period or second intervention period.
Dorzolamide/timolol Maleate Fixed Combination (COSOPT)Drug
Also called COSOPT®
Dorzolamide/timolol maleate fixed combination, one drop instilled in one eye at baseline, followed by one drop instilled in each eye once in either first intervention period or second intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Azarga/Cosopt | Active comparator | Following administration of the baseline dose (each intervention instilled in one eye in a contralateral fashion to establish baseline ocular comfort for each medication), Azarga will be instilled one drop in each eye on Day One, after which Cosopt will be administered one drop in each eye on Day Two. Receives: Drug: Brinzolamide/Timolol Maleate Fixed Combination (AZARGA); Drug: Dorzolamide/timolol Maleate Fixed Combination (COSOPT) |
| Cosopt/Azarga | Active comparator | Following administration of the baseline dose (each intervention instilled in one eye in a contralateral fashion to establish baseline ocular comfort for each medication), Cosopt will be administered one drop in each eye on Day One, after which Azarga will be administered one drop in each eye on Day Two. Receives: Drug: Brinzolamide/Timolol Maleate Fixed Combination (AZARGA); Drug: Dorzolamide/timolol Maleate Fixed Combination (COSOPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discomfort
One drop of medication will be instilled in each eye. At one minute after instillation, subject will be given an Ocular Discomfort Scale and will record ocular discomfort on a questionnaire using a 10-point scale, with 0 being no discomfort and 09 being substantial discomfort.
Measured: One minute after instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2011 (estimated)
- Study startSep 2010
- Primary completionMay 2011
- Study completionMay 2011
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abayomi Ogundele, PharmD, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471158
- Sponsor's protocol ID
- SMA-09-18
- Status last verified
- Nov 2011
- First submitted
- 10 Nov 2011
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
https://www.dovepress.com/preference-for-a-fixed-combination-of-brinzolamidetimolol-versus-dorzo-peer-reviewed-article-OPTH
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Preference Comparison of AZARGA Versus COSOPT After Single Doses in Patients With Open-Angled Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT01471158
- Acronym / sponsor ID
- SMA-09-18
- Conditions
- Glaucoma
- Keywords
- Primary open-angle glaucoma, ocular hypertension, pigment dispersion glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 15 Nov 2011 (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 assess patient preference of AZARGA® compared to COSOPT® after a single drop of each medication is administered to both eyes, in patients with open-angled glaucoma or ocular hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azarga/Cosopt | Active comparator | Drug: Brinzolamide/Timolol Maleate Fixed Combination (AZARGA), Drug: Dorzolamide/timolol Maleate Fixed Combination (COSOPT)Following administration of the baseline dose (each intervention instilled in one eye in a contralateral fashion to establish baseline ocular comfort for each medication), Azarga will be instilled one drop in each eye on Day One, after which Cosopt will be administered one drop in each eye on Day Two. |
| Cosopt/Azarga | Active comparator | Drug: Brinzolamide/Timolol Maleate Fixed Combination (AZARGA), Drug: Dorzolamide/timolol Maleate Fixed Combination (COSOPT)Following administration of the baseline dose (each intervention instilled in one eye in a contralateral fashion to establish baseline ocular comfort for each medication), Cosopt will be administered one drop in each eye on Day One, after which Azarga will be administered one drop in each eye on Day Two. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
- On a stable regimen intraocular pressure (IOP) lowering medication within 30 days of screening visit.
- IOP considered to be safe (in the opinion of the investigator) in both eyes in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
- Willing to discontinue use of all other ocular drugs (prescribed and over-the-counter) prior to receiving the screening dose during Screening Visit and for the course of the study.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (7 listed)
- Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in this study that is deemed clinical significant in the opinion of the Principal Investigator.
- Corneal dystrophies in either eye.
- Risk of visual field or visual acuity worsening as a consequence of participating in this study, in the investigator's best judgment.
- Bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
- History of severe allergic rhinitis.
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/Timolol Maleate Fixed Combination (AZARGA)Also: AZARGA®Brinzolamide/timolol maleate fixed combination, one drop instilled in one eye at baseline, followed by one drop instilled in each eye once in either first intervention period or second intervention period. | Drug | Azarga/Cosopt, Cosopt/Azarga |
| Dorzolamide/timolol Maleate Fixed Combination (COSOPT)Also: COSOPT®Dorzolamide/timolol maleate fixed combination, one drop instilled in one eye at baseline, followed by one drop instilled in each eye once in either first intervention period or second intervention period. | Drug | Azarga/Cosopt, Cosopt/Azarga |
Primary outcome
Discomfort
Time frame: One minute after instillation
One drop of medication will be instilled in each eye. At one minute after instillation, subject will be given an Ocular Discomfort Scale and will record ocular discomfort on a questionnaire using a 10-point scale, with 0 being no discomfort and 09 being substantial discomfort.
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 21 Nov 2016.
- Results publicationhttps://www.dovepress.com/preference-for-a-fixed-combination-of-brinzolamidetimolol-versus-dorzo-peer-reviewed-article-OPTH
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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.
Abayomi Ogundele, PharmD study director
Alcon Research
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 Brinzolamide/Timolol Maleate Fixed Combination (AZARGA) and Dorzolamide/timolol Maleate Fixed Combination (COSOPT) in people with Glaucoma, run by Alcon Research at 1 site in Argentina.
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 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 21 Nov 2016. 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 Argentina. 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?
Discomfort (time frame: One minute after instillation). 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 NCT01471158, 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 21 Nov 2016; AzTrials last refreshed its copy on 7 Nov 2026.