Open-Angle GlaucomaPhase 4NCT02325518
Comparison of Intraocular Pressure (IOP)-Lowering Efficacy and Safety of AZORGA® Ophthalmic Suspension and COSOPT® Ophthalmic Solution
A Phase 4 study testing Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution and Subject's habitual PGA monotherapy in people with Open-Angle Glaucoma and Ocular Hypertension, run by Alcon, a Novartis Company at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate AZORGA® Ophthalmic Suspension compared to COSOPT® Ophthalmic Solution for IOP-lowering efficacy in subjects with open-angle glaucoma or ocular hypertension. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Open-Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution and Subject's habitual PGA monotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2014to Dec 2015
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand the nature of the study and sign informed consent.
- Diagnosis of open angle glaucoma or ocular hypertension.
- Currently on PGA monotherapy or PGA + alpha-1/beta blocker or PGA + alpha-2 agonist at screening visit, and allowed to instill only PGA for 4 weeks until the baseline visit.
- Intraocular pressure (IOP) ≥ 15 mmHg (at least one same eye) at the baseline visit.
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- History of bronchial asthma, bronchospasm, or serious chronic obstruction pulmonary disease.
- Uncontrolled heart failure, sinus bradycardia, A-V block (II, III grade), cardiogenic shock, right heart failure due to pulmonary hypertension or congestive heart failure.
- History of hypersensitivity to any of the excipients of the study medications.
- Severe renal function disorders, diabetic ketoacidosis and metabolic acidosis, uncontrolled diabetes, or hepatic disorders.
- Corneal disorder or history of chronic, recurrent or current severe inflammatory eye disease in either eye.
- History of ocular trauma in either eye within 6 months prior to the screening examination.
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- Ocular infection or ocular inflammation in either eye.
- History of or current clinically significant or progressive retinal disease in either eye.
- Intraocular surgery in either eye within 6 months prior to the screening examination.
- Ocular laser surgery in either eye within 3 months prior to the screening examination.
- Any abnormality preventing reliable applanation tonometry of either eye.
- Best-corrected visual acuity (BCVA) worse than 0.2 score (decimal visual acuity) in either eye.
- Severe visual field loss in either eye.
- Use of prohibited medication, as specified in the protocol.
- Pregnant, lactating, or intending to become pregnant during the study period.
- Currently on therapy or have been on therapy with another investigational agent within 30 days prior to the screening examination.
- History of or current evidence of a severe illness or any other condition which would make the subject, in the opinion of the investigator, unsuitable for the study.
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of Brinzolamide 1%/Timolol 0.5% Fixed Combination Versus Dorzolamide 1%/Timolol 0.5% in Patients With Open-Angle Glaucoma and Ocular Hypertension
The purpose of this study is to evaluate AZORGA® Ophthalmic Suspension compared to COSOPT® Ophthalmic Solution for IOP-lowering efficacy in subjects with open-angle glaucoma or ocular hypertension.
Read the detailed description
After the screening examination, subjects were enrolled in the study and moved into the observation period. During the observation period, prostaglandin-analog (PGA) monotherapy was applied. After the observation period of 4 weeks or more, the baseline examination was performed. Subjects were then randomized and moved into the treatment period.
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Being tested
- Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, Subject's habitual PGA monotherapy
- Keywords
- Open-angle glaucoma (OAG), Ocular hypertension (OHT), AZORGA®, COSOPT®
- 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.
Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspensionDrug
Also called AZORGA®
Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solutionDrug
Also called COSOPT®
Subject's habitual PGA monotherapyDrug
| Study group | Role | What they receive |
|---|---|---|
| BRI/TIM | Experimental | Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks. Receives: Drug: Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension; Drug: Subject's habitual PGA monotherapy |
| DOR/TIM | Active comparator | Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks. Receives: Drug: Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution; Drug: Subject's habitual PGA monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Least Squares Mean Change From Baseline in Intraocular Pressure (IOP) at 11 AM
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data from 4 and 8 weeks at 11 AM were pooled, and a negative change indicates an improvement. One eye (target eye) was used for the analysis.
Measured: Baseline (Day 0), Week 4, Week 8 at 11 AM
Secondary outcomes (1)
Least Squares Mean Change From Baseline in IOP at 9 AM
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data from 4 and 8 weeks at 9 AM were pooled, and a negative change indicates an improvement. One eye (target eye) was used for the analysis.
Measured: Baseline (Day 0), Week 4, Week 8 at 9 AM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2015
- Study completionDec 2015
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.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon, a Novartis Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical and Regulatory Affairs, Study director, Alcon Japan, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325518
- Sponsor's protocol ID
- ALJ-P2014-1
- Other IDs
- UMIN000017569
- Status last verified
- Oct 2016
- First submitted
- 22 Dec 2014
- Last updated
- 8 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Brinzolamide 1%/Timolol 0.5% Fixed Combination Versus Dorzolamide 1%/Timolol 0.5% in Patients With Open-Angle Glaucoma and Ocular Hypertension
- ClinicalTrials.gov ID
- NCT02325518
- Acronym / sponsor ID
- ALJ-P2014-1
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Keywords
- Open-angle glaucoma (OAG), Ocular hypertension (OHT), AZORGA®, COSOPT®
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Alcon, a Novartis CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Dec 2014 (estimated)
- Results
- Posted 8 Dec 2016
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 evaluate AZORGA® Ophthalmic Suspension compared to COSOPT® Ophthalmic Solution for IOP-lowering efficacy in subjects with open-angle glaucoma or ocular hypertension.
Detailed description
After the screening examination, subjects were enrolled in the study and moved into the observation period. During the observation period, prostaglandin-analog (PGA) monotherapy was applied. After the observation period of 4 weeks or more, the baseline examination was performed. Subjects were then randomized and moved into the treatment period.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BRI/TIM | Experimental | Drug: Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, Drug: Subject's habitual PGA monotherapyBrinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks. |
| DOR/TIM | Active comparator | Drug: Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, Drug: Subject's habitual PGA monotherapyDorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Understand the nature of the study and sign informed consent.
- Diagnosis of open angle glaucoma or ocular hypertension.
- Currently on PGA monotherapy or PGA + alpha-1/beta blocker or PGA + alpha-2 agonist at screening visit, and allowed to instill only PGA for 4 weeks until the baseline visit.
- Intraocular pressure (IOP) ≥ 15 mmHg (at least one same eye) at the baseline visit.
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (18 listed)
- History of bronchial asthma, bronchospasm, or serious chronic obstruction pulmonary disease.
- Uncontrolled heart failure, sinus bradycardia, A-V block (II, III grade), cardiogenic shock, right heart failure due to pulmonary hypertension or congestive heart failure.
- History of hypersensitivity to any of the excipients of the study medications.
- Severe renal function disorders, diabetic ketoacidosis and metabolic acidosis, uncontrolled diabetes, or hepatic disorders.
- Corneal disorder or history of chronic, recurrent or current severe inflammatory eye disease in either eye.
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%/Timolol maleate 0.5% fixed combination ophthalmic suspensionAlso: AZORGA® | Drug | BRI/TIM |
| Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solutionAlso: COSOPT® | Drug | DOR/TIM |
| Subject's habitual PGA monotherapy | Drug | BRI/TIM, DOR/TIM |
Primary outcome
Least Squares Mean Change From Baseline in Intraocular Pressure (IOP) at 11 AM
Time frame: Baseline (Day 0), Week 4, Week 8 at 11 AM
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data from 4 and 8 weeks at 11 AM were pooled, and a negative change indicates an improvement. One eye (target eye) was used for the analysis.
1 secondary outcome
Least Squares Mean Change From Baseline in IOP at 9 AM
Time frame: Baseline (Day 0), Week 4, Week 8 at 9 AM
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clinical and Regulatory Affairs study director
Alcon Japan, Ltd.
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 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution and Subject's habitual PGA monotherapy in people with Open-Angle Glaucoma and Ocular Hypertension, run by Alcon, a Novartis Company at 1 site in Japan.
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 18 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 Dec 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 Japan. 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?
Yes. Results are posted in the registry (first posted 8 Dec 2016). 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?
Least Squares Mean Change From Baseline in Intraocular Pressure (IOP) at 11 AM (time frame: Baseline (Day 0), Week 4, Week 8 at 11 AM). 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 Dec 2016.