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GlaucomaPhase 4NCT01263444

Safety and Efficacy of Adding AZARGA® Adjunctive to Prostaglandin Therapy

A Phase 4 study testing Brinzolamide 1% / timolol 0.5% Fixed Combination and Habitual prostaglandin monotherapy in people with 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 evaluate the safety and efficacy of adding AZARGA® as a single agent to prostaglandin monotherapy in patients with either ocular hypertension or primary open-angle glaucoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glaucoma, Ocular Hypertension
What is being tested?
Brinzolamide 1% / timolol 0.5% Fixed Combination and Habitual prostaglandin monotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
No sites listed yet
Study dates
Mar 2011to Apr 2013
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, primary open angle (including pigment dispersion) glaucoma in both eyes.
  • IOP considered to be safe, in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
  • Treated with, and in the Investigator's judgment demonstrated an inadequate response to, prostaglandin monotherapy for a minimum of 4 weeks at Visit 1. Last dose of prostaglandin instilled correctly to put patient within the dosing cycle at Visit 1.
  • At Visit 1, have an IOP of ≥ 20 mmHg in at least one eye and ≤ 35 mmHg in both eyes treated with prostaglandin monotherapy.
  • Best corrected visual acuity of 1.0 LogMAR or better in each eye.
  • In any eye not qualifying as a study eye, IOP should be able to be controlled on no pharmacologic therapy or on prostaglandin monotherapy alone.
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  • Willing to sign an informed consent form.
  • Able to follow instructions and willing and able to attend required study visits.
  • Other protocol-defined inclusion criteria may apply.

Who cannot join

  • Known medical history of allergy, hypersensitivity or poor tolerance to any component of AZARGA® that is deemed clinically significant in the opinion of the investigator.
  • A history of, or at risk for uveitis or cystoid macular edema (CME).
  • History of ocular herpes simplex.
  • Corneal dystrophies in either eye.
  • Concurrent infectious/non infectious conjunctivitis, keratitis or uveitis in either eye (excluding Blepharitis or non-clinically significant conjunctival hyperemia).
  • Intraocular conventional surgery or laser surgery in study eye(s) less than 3 months prior to Visit 1.
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  • 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 apart from glaucoma.
  • Use of systemic medications known to affect IOP (e.g. oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for 7 days prior to Visit 1 or an anticipated change in the dosage during the course of the study.
  • Use of corticosteroids (oral, topical ocular or nasal) within 30 days of Visit 1 and during the course of the study.
  • Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
  • History of severe allergic rhinitis.
  • A condition, which in the opinion of the principal investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject.
  • Use of any systemic carbonic anhydrase inhibitors (CAI) (e.g. methazolamide [Neptazane], acetazolamide [Diamox]).
  • Severely impared renal function.
  • History of an allergy to sulphonamides.
  • Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, severe allergic rhinitis or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
  • Pregnant, lactating, or of childbearing potential and not using a reliable method of birth control.
  • Any clinically significant, serious, or severe medical condition.
  • 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: Efficacy and Safety of Adding the Brinzolamide/Timolol Maleate Fixed Combination (AZARGA®) to Ocular Hypertensive or Glaucoma Patients Uncontrolled on Prostaglandin Monotherapy

The purpose of this study was to evaluate the safety and efficacy of adding AZARGA® as a single agent to prostaglandin monotherapy in patients with either ocular hypertension or primary open-angle glaucoma.

Read the detailed description

This study consisted of 3 study visits (Screening/Baseline, Week 4, and Week 12). Eligible patients self-administered the study medication (AZARGA® Eye Drops), adjunct to their current prostaglandin monotherapy for 3 months.

Being tested
Brinzolamide 1% / timolol 0.5% Fixed Combination, Habitual prostaglandin monotherapy
Keywords
AZARGA®, Open angle glaucoma, Prostaglandin Therapy
Medical subject headings
Glaucoma, Ocular Hypertension, Glaucoma, Open-Angle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brinzolamide 1% / timolol 0.5% Fixed CombinationDrug

    Also called AZARGA®

  • Habitual prostaglandin monotherapyDrug

    Also called Latanoprost, Travoprost, Bimatoprost, Tafluprost

    Topical ocular therapy used daily as prescribed

Study groups in NCT01263444
Study groupRoleWhat they receive
AzargaExperimentalBrinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
Receives: Drug: Brinzolamide 1% / timolol 0.5% Fixed Combination; Drug: Habitual prostaglandin monotherapy

What is being measured

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

  1. Mean Change From Baseline in Intraocular Pressure (IOP) at Week 12

    IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. Only one eye (study eye) contributed to the mean.

    Measured: Baseline, Week 12

Secondary outcomes (3)

  1. Mean Change From Baseline in IOP Per Prostaglandin Group at Week 12

    IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. Only prostaglandin subgroups with ≥ 15 patients were analyzed. Only one eye (study eye) contributed to the mean.

    Measured: Baseline, Week 12

  2. Mean Change From Baseline in IOP at Week 4

    IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. Only one eye (study eye) contributed to the mean.

    Measured: Baseline, Week 4

  3. Percentage of Patients Reaching the Target IOP (≤ 18 mmHg)

    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye (study eye) was assessed.

    Measured: Week 12

Timeline

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

  1. First posted20 Dec 2010 (estimated)
  2. Study startMar 2011
  3. Primary completionApr 2013
  4. Study completionApr 2013

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01263444
Sponsor's protocol ID
RDG-10-246
Other IDs
2010-022948-21
Status last verified
May 2014
First submitted
17 Dec 2010
Last updated
20 May 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Brinzolamide 1% / timolol 0.5% Fixed Combination and Habitual prostaglandin monotherapy in people with Glaucoma and Ocular Hypertension, run by Alcon Research.

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 9 inclusion and 21 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 20 May 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 19 May 2014). 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?

Mean Change From Baseline in Intraocular Pressure (IOP) at Week 12 (time frame: Baseline, Week 12). 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 NCT01263444.

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 20 May 2014.

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