Open-Angle GlaucomaPhase 4NCT01340014

Patient Preference Comparison of AZARGA Versus COSOPT

A Phase 4 study testing Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspension and Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution in people with Open-Angle Glaucoma and Ocular Hypertension, run by Alcon Research.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study was to assess patient preference regarding ocular comfort of AZARGA® compared to COSOPT® after one week instillation of each study medication. 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?: Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspension and Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 112 participants
Where: No sites listed yet
Study dates: Sep 2011to Oct 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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, open-angle with or without pseudoexfoliation or pigment dispersion glaucoma in both eyes.
On a stable regimen of intraocular pressure-lowering (IOP) medication within 30 days of Screening Visit.
IOP considered safe (in the opinion of the Investigator) in both eyes in such a way that assures clinical stability of vision and the optic nerve throughout the study period.
IOP between 19 and 35 millimeters mercury (mmHg) in at least one eye (study eye).
Willing to discontinue the use of all other ocular drugs (prescribed and over-the-counter) prior to receiving the screening dose during the Screening Visit and for the entire course of the study.
Able to follow instructions and willing and able to attend all study visits.
Read, sign, and date an Ethics Committee reviewed and approved Informed Consent Form.
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 clinically significant in the opinion of the Principal Investigator.
Best corrected visual acuity worse than 20/80 Snellen in either eye.
Any abnormality preventing reliable applanation tonometry in either eye.
Intraocular conventional surgery or laser surgery in either eye less than 3 months prior to the Screening Visit.
Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the Investigator's best judgment.
Progressive retinal or optic nerve disease from any cause.

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History of ocular herpes simplex.
Severe allergic rhinitis or bronchial hypersensitivity that would preclude the safe administration of a topical beta-blocker.
Bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
Women who are pregnant, lactating, or of childbearing potential and not using a reliable means of birth control.
Participation in any other investigational study within 30 days prior to the Screening/baseline Visit.
Other protocol-defined exclusion criteria may apply.

About this study

Official title: Patient Preference Comparison of AZARGA Versus COSOPT in Patients With Open-Angle Glaucoma or Ocular Hypertension

The purpose of this study was to assess patient preference regarding ocular comfort of AZARGA® compared to COSOPT® after one week instillation of each study medication.

Read the detailed description

At the Screening Visit, each intervention was instilled in one eye in a contralateral fashion to establish baseline ocular comfort prior to randomization. A 48-hour washout period separated the two treatment periods.

Conditions: Open-Angle Glaucoma, Ocular Hypertension
Being tested: Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspension, Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution
Keywords: Glaucoma, Intraocular pressure, Tonometry, ocular
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.

Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspensionDrug
Also called AZARGA®
Dorzolamide 2.0% + Timolol 0.5% ophthalmic solutionDrug
Also called COSOPT®

Study groups in NCT01340014
Study group	Role	What they receive
AZARGA/COSOPT	Other	1 drop AZARGA instilled in each eye twice a day for 7 days, followed by 1 drop COSOPT instilled in each eye twice a day for 7 days. A 48-hour washout period separated the two treatment periods. Receives: Drug: Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspension; Drug: Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution
COSOPT/AZARGA	Other	1 drop COSOPT instilled in each eye twice a day for 7 days, followed by 1 drop AZARGA instilled in each eye twice a day for 7 days. A 48-hour washout period separated the two treatment periods. Receives: Drug: Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspension; Drug: Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Preferred Treatment
The participant completed a questionnaire on the Day 15 visit (ie, after administration of both study medications) consisting of a single preference question: "Thinking about the comfort of the two medications (1st and 2nd) that you took during this study, which medication do you prefer?" Preferred treatment is presented as a percentage.
Measured: At the end of both periods, Day 15

Secondary outcomes (1)

Ocular Discomfort
Ocular discomfort was assessed by the participant 1 minute after instillation of the study medication. Ocular discomfort was rated on a 10-point scale (0=no discomfort, 9=substantial discomfort).
Measured: Day 7 of each period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2011Oct 2012

First posted21 Apr 2011 (estimated)
Study startSep 2011
Primary completionOct 2012
Study completionOct 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Open-Angle 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: 112 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01340014
Sponsor's protocol ID: RDG-10-251
Other IDs: 2010-024244-15
Status last verified: Jan 2014
First submitted: 20 Apr 2011
Last updated: 10 Feb 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
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All Open-Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Patient Preference Comparison of AZARGA Versus COSOPT in Patients With Open-Angle Glaucoma or Ocular Hypertension
ClinicalTrials.gov ID: NCT01340014
Acronym / sponsor ID: RDG-10-251
Conditions: Open-Angle Glaucoma, Ocular Hypertension
Keywords: Glaucoma, Intraocular pressure, Tonometry, ocular
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 112 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Sep 2011
Primary completion: Oct 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 21 Apr 2011 (estimated)
Results: Posted 13 Dec 2013

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 was to assess patient preference regarding ocular comfort of AZARGA® compared to COSOPT® after one week instillation of each study medication.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
AZARGA/COSOPT	Other	Drug: Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspension, Drug: Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution1 drop AZARGA instilled in each eye twice a day for 7 days, followed by 1 drop COSOPT instilled in each eye twice a day for 7 days. A 48-hour washout period separated the two treatment periods.
COSOPT/AZARGA	Other	Drug: Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspension, Drug: Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution1 drop COSOPT instilled in each eye twice a day for 7 days, followed by 1 drop AZARGA instilled in each eye twice a day for 7 days. A 48-hour washout period separated the two treatment periods.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Clinical diagnosis of ocular hypertension, open-angle with or without pseudoexfoliation or pigment dispersion glaucoma in both eyes.
On a stable regimen of intraocular pressure-lowering (IOP) medication within 30 days of Screening Visit.
IOP considered safe (in the opinion of the Investigator) in both eyes in such a way that assures clinical stability of vision and the optic nerve throughout the study period.
IOP between 19 and 35 millimeters mercury (mmHg) in at least one eye (study eye).
Willing to discontinue the use of all other ocular drugs (prescribed and over-the-counter) prior to receiving the screening dose during the Screening Visit and for the entire course of the study.

Key exclusion criteria (12 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 clinically significant in the opinion of the Principal Investigator.
Best corrected visual acuity worse than 20/80 Snellen in either eye.
Any abnormality preventing reliable applanation tonometry in either eye.
Intraocular conventional surgery or laser surgery in either eye less than 3 months prior to the Screening Visit.
Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the Investigator's best judgment.

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 1.0% + Timolol 0.5% ophthalmic suspensionAlso: AZARGA®	Drug	AZARGA/COSOPT, COSOPT/AZARGA
Dorzolamide 2.0% + Timolol 0.5% ophthalmic solutionAlso: COSOPT®	Drug	AZARGA/COSOPT, COSOPT/AZARGA

Primary outcome

Preferred Treatment
Time frame: At the end of both periods, Day 15
The participant completed a questionnaire on the Day 15 visit (ie, after administration of both study medications) consisting of a single preference question: "Thinking about the comfort of the two medications (1st and 2nd) that you took during this study, which medication do you prefer?" Preferred treatment is presented as a percentage.

1 secondary outcome

Ocular Discomfort
Time frame: Day 7 of each period

Results and safety

Results posted to the registry on 13 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZARGA/COSOPT	55	53
COSOPT/AZARGA	57	57

Primary outcome: Preferred Treatment

Time frame: At the end of both periods, Day 15. Number. Unit: Percentage of participants

Measure	AZARGA n = 108	COSOPT n = 108
Value	60.2	39.8

Population analysed: This reporting group includes all participants who completed both treatment periods and completed the preference questionnaire, as treated.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected for the duration of the study (September 2011 to October 2012). An adverse event was defined as any untoward medical condition in a subject administered a study treatment regardless of causal relationship.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZARGA	0 of 112 (0%)	0 of 112 (0%)	Not reported
COSOPT	0 of 112 (0%)	0 of 112 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Open-Angle Glaucoma

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
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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.

Severine Durier, Pharm.D study director

Alcon Global Medical Affairs, Europe

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 12 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 10 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 13 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Preferred Treatment (time frame: At the end of both periods, Day 15). 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 NCT01340014.

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 10 Feb 2014.