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CompletedNCT00966576Updated Nov 21, 2016

Efficacy and Safety of Adding Azarga to Prostaglandin Monotherapy

A Phase 4 interventional study of Brinzolamide/Timolol Maleate Fixed Combination (AZARGA) in Glaucoma, sponsored by Alcon Research. Completed at 1 site in Germany. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2016-11-21.

Sponsored by Alcon Research · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
47
Allocation
Non-randomized
Ages
21 Years and older
Sex
All
01

Study summary

The purpose of this study is to assess the safety and efficacy of adding AZARGA in glaucoma patients with uncontrolled intraocular pressure (IOP), currently on prostaglandin monotherapy.

02

Conditions studied

  • Glaucoma

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Keywords

  • Glaucoma
  • IOP
  • AZARGA
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 47 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.

Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Sign Informed Consent.
  • 21 years of age or older.
  • Able to follow instructions and willing to attend required study visits.
  • Clinical diagnosis of ocular hypertension, primary open-angle, or pigment dispersion glaucoma in at least one eye (qualifying eye).
  • Intra-ocular pressure (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 trial.
  • Must have best corrected visual acuity of 6/60 (6/60 Snellen, 1.0 LogMAR) or better in each eye.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Exclusion Criteria:

  • Presence of other primary or secondary glaucomas not listed in inclusion criterion.
  • Presence of corneal dystrophies.
  • Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
  • Intraocular conventional surgery or laser surgery in qualifying eye(s) less than three months prior to Visit 1.
  • Risk of visual field or visual acuity worsening as a consequence of participation in the trial, in the investigator's best judgment.
  • Women of childbearing potential not using reliable means of birth control.
  • Women who are pregnant or lactating.
  • Participation in any other investigational study within 30 days prior to Visit 1.
  • Current or anticipated use of systemic corticosteroids, by any route except inhaled, for greater than two weeks during the trial.
  • Severe allergic rhinitis
  • History of ocular herpes simplex.
  • Other protocol-defined exclusion criteria may apply.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
47 participants (actual)

Study arms

  • Experimental
    Brinzolamide/Timolol Maleate Fixed Combination

    Drug: Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)

Interventions

  • DrugBrinzolamide/Timolol Maleate Fixed Combination (AZARGA)

    1 drop of study medication into the study eye(s) beginning the evening of Visit 1 and continuing twice daily (morning and evening) for 12 weeks

    Also known as: AZARGA

06

What researchers measure

Primary outcomes

  1. The mean decrease in intraocular pressure (IOP) at 12 weeks from baseline

    Time frame: 12 weeks

Secondary outcomes

  1. Safety as determined by visual acuity, biomicroscopy, adverse events, solicited symptom survey and treatment success

    Time frame: Week 4 and Week 12

07

Study locations

1 site
  • Mainz, 55101, Germany
08

References and documents

Publications

  • Lorenz K, Rosbach K, Matt A, Pfeiffer N. Addition of a fixed combination of brinzolamide 1%/timolol 0.5% to prostaglandin monotherapy in patients with glaucoma or ocular hypertension. Clin Ophthalmol. 2011;5:1745-50. doi: 10.2147/OPTH.S25987. Epub 2011 Dec 9. PubMed 22205835 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00966576
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Aug 27, 2009
Start date
Jul 2009
Primary completion
Aug 2010
Completion
Aug 2010
Last update
Nov 21, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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