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Open-Angle GlaucomaPhase 3NCT01357616

Fixed Combination Brinzolamide 1%/Timolol 0.5% Versus Brinzolamide 1% + Timolol 0.5% in Open-Angle Glaucoma or Ocular Hypertension

A Phase 3 study testing Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, Brinzolamide 1% ophthalmic suspension and 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 compare the intraocular pressure (IOP)-lowering efficacy and safety of AZARGA™ (Brinzolamide 1%/Timolol 0.5% Ophthalmic Suspension), dosed twice daily versus AZOPT® (Brinzolamide 1% Ophthalmic Suspension) and Timolol 0.5% Ophthalmic Solution, each dosed twice daily, in Chinese patients… 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% / Timolol 0.5% fixed combination ophthalmic suspension, Brinzolamide 1% ophthalmic suspension and Timolol 0.5% ophthalmic solution
Could I receive a placebo?
No, everyone receives an active treatment
How many people
328 participants
Where
No sites listed yet
Study dates
Nov 2010to Jan 2013
Phase
Phase 3
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

  • Diagnosed with open angle glaucoma and/or ocular hypertension and not sufficiently responsive to monotherapy.
  • Meet qualifying IOP criteria in at least 1 eye, including 21-35 mmHg at the Eligibility visit.
  • Willing to sign an Informed Consent form.
  • Contact lens wearer who is willing to remove lenses before instillation of study medication and wait a minimum of 15 minutes following drug instillation before re-inserting the lenses.
  • Able to discontinue use of current IOP-lowering medications per the minimum washout period.
  • Other protocol-specific inclusion criteria may apply.

Who cannot join

  • Women of childbearing potential if pregnant, test positive for pregnancy at Screening/Enrollment visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
  • Diagnosed with any form of glaucoma other than open-angle glaucoma and/or ocular hypertension.
  • Diagnosed with severe central visual field loss in either eye.
  • History of chronic, recurrent, or severe ocular infection, inflammatory eye disease in either eye.
  • History of ocular trauma within the past 6 months in either eye.
  • Current ocular infection or ocular inflammation within the past 3 months in either eye.
Show all 22Show fewer
  • Ocular laser surgery within the past 3 months.
  • Intraocular surgery within the past 3 months.
  • Best-corrected visual acuity score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen, 0.60 logMAR or 0.25 decimal).
  • History of, or current clinically relevant or progressive retinal disease in either eye.
  • History of, or current other severe ocular pathology (including severe dry eye) in either eye, that would preclude the administration of a topical carbonic anhydrase inhibitor (CAI) or beta-blocker.
  • Any abnormality preventing reliable applanation tonometry.
  • History of, or current condition or disease that would preclude the safe administration of a topical beta blocker or topical beta-adrenergic blocking agent.
  • History of spontaneous or current hypoglycemia or uncontrolled diabetes.
  • History of severe or serious hypersensitivity to CAIs, beta-blockers, or to any components of the study medication.
  • Less than 30 days stable dosing regimen before the Screening Visit of any medications or substances administered by any route and used on a chronic basis that may have affected IOP.
  • Recent use of high-dose salicylate therapy.
  • Anticipated use of any additional topical or systemic ocular hypotensive medication during the study.
  • Not safely able to discontinue all glucocorticoid medications administered by any route.
  • Currently on therapy or have been on therapy with another investigational agent within 30 days prior to the Screening Visit.
  • History of, or current evidence of severe illness or any other conditions which would, in the opinion of the Investigator, make the subject unsuitable for the study.
  • Other protocol-specific exclusion criteria may apply.

About this study

Official title: Comparison of Efficacy and Safety of Brinzolamide/Timolol Fixed Combination (AZARGA™) vs Brinzolamide (AZOPT®) and Timolol in Chinese Subjects With Open-Angle Glaucoma or Ocular Hypertension

The purpose of this study was to compare the intraocular pressure (IOP)-lowering efficacy and safety of AZARGA™ (Brinzolamide 1%/Timolol 0.5% Ophthalmic Suspension), dosed twice daily versus AZOPT® (Brinzolamide 1% Ophthalmic Suspension) and Timolol 0.5% Ophthalmic Solution, each dosed twice daily, in Chinese patients with open-angle glaucoma or ocular hypertension who were insufficiently responsive to monotherapy.

Read the detailed description

The study consisted of 2 sequential phases. Phase I was the Screening/Eligibility Phase, with a Screening Visit followed by an Eligibility Visit. Phase II was the treatment phase and included Week 1, Week 2, Week 4, and Week 8 visits. Eligible subjects were randomized in a 1:1 ratio to receive Brinzolamide 1%/Timolol 0.5% or Brinzolamide 1% plus Timolol 0.5% two times a day for 8 weeks.

Being tested
Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, Brinzolamide 1% ophthalmic suspension, Timolol 0.5% ophthalmic solution
Keywords
Glaucoma, Open-angle glaucoma, Ocular hypertension, OAG, OH
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% / Timolol 0.5% fixed combination ophthalmic suspensionDrug

    Also called AZARGA™

  • Brinzolamide 1% ophthalmic suspensionDrug

    Also called AZOPT®

  • Timolol 0.5% ophthalmic solutionDrug

    Also called TIMOLOL

Study groups in NCT01357616
Study groupRoleWhat they receive
AZARGAExperimentalBrinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
Receives: Drug: Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension
AZOPT + TimololActive comparatorBrinzolamide 1% ophthalmic suspension, 1 drop instilled in the affected eye(s), followed by Timolol 0.5% ophthalmic solution, 1 drop instilled in the affected eye(s). Approximately 10 minutes separated the 2 instillations. The study drugs were instilled twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
Receives: Drug: Brinzolamide 1% ophthalmic suspension; Drug: Timolol 0.5% ophthalmic solution

What is being measured

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

  1. Mean Diurnal IOP Change From Baseline at Week 8

    Mean diurnal IOP change from baseline at Week 8 (ie, the subject IOP change from baseline averaged over the 9 AM, 11AM and 5 PM time points at Week 8) was measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP (fluid pressure inside the eye) can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater improvement..

    Measured: Baseline, Week 8

Secondary outcomes (3)

  1. Mean IOP Change From Baseline at 9 AM

    Mean IOP change from baseline at 9 AM was measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP (fluid pressure inside the eye) can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater improvement.

    Measured: Baseline, Up to Week 8

  2. Mean IOP Change From Baseline at 11 AM

    Mean IOP change from baseline at 11 AM was measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP (fluid pressure inside the eye) can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater improvement.

    Measured: Baseline, Up to Week 8

  3. Mean IOP Change From Baseline (5 PM) at Week 8

    Mean IOP change from baseline (5 PM) at Week 8 was measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP (fluid pressure inside the eye) can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater improvement.

    Measured: Baseline, Week 8

Timeline

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

  1. First posted20 May 2011 (estimated)
  2. Study startNov 2010
  3. Primary completionJan 2013
  4. Study completionJan 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
328 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01357616
Sponsor's protocol ID
C-08-076
Status last verified
Mar 2014
First submitted
18 May 2011
Last updated
10 Apr 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, Brinzolamide 1% ophthalmic suspension and Timolol 0.5% ophthalmic solution in people with Open-Angle 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 6 inclusion and 22 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 Apr 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Mar 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 Diurnal IOP Change From Baseline at Week 8 (time frame: Baseline, Week 8). 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 NCT01357616.

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 Apr 2014; AzTrials last refreshed its copy on 6 Nov 2026.

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