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OpenTrials
Completed

NCT Number: NCT00966576

Efficacy and Safety of Adding Azarga to Prostaglandin Monotherapy

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mainz, 55101, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)

Drug

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

Other names: AZARGA

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

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

The Efficacy and Safety of Adding the Brinzolamide/Timolol Maleate Fixed Combination (Azarga®) to Prostaglandin Monotherapy

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 27, 2009
Registry last updated
Nov 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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