Mainz, 55101, Germany
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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Conditions
Age range
21 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
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)
Drug1 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
-
The mean decrease in intraocular pressure (IOP) at 12 weeks from baseline
Time frame: 12 weeks
Secondary outcomes
-
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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