Safety and Efficacy of Adding Azarga Adjunctive to Prostaglandin Therapy
This study has been completed.
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01263444
First received: December 17, 2010
Last updated: May 2, 2013
Last verified: May 2013
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Purpose
The purpose of this study is 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Glaucoma |
Drug: Brinzolamide/Timolol Maleate Fixed Combination (Azarga) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Mean Intraocular Pressure (IOP) change from baseline at Month 3. [ Time Frame: 3 months ] [ Designated as safety issue: No ]All IOP measurements will be performed with a Goldmann applanation tonometer.
| Enrollment: | 47 |
| Study Start Date: | March 2011 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Azarga
Azarga added to current prostaglandin therapy (historical control)
|
Drug: Brinzolamide/Timolol Maleate Fixed Combination (Azarga)
Brinzolamide/Timolol Maleate Fixed Combination administered as 1 drop in treated eye(s) twice daily for 3 months in addition to current prostaglandin therapy.
Other Name: Azarga
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Must be 18 years of age or older.
- Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
- At Screening/baseline visit, must have an IOP of ≥ 20 millimeters mercury (mm Hg) in at least one eye and ≤ 35 mm Hg in both eyes treated with prostaglandin monotherapy.
- In any eye not qualifying as a study eye, the intraocular pressure should be able to be controlled on no pharmacologic therapy or on prostaglandin monotherapy alone.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- 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.
- Corneal dystrophies in either eye
- Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
- 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.
- Participation in any other investigational study within 30 days prior to the screening/baseline visit.
- Other protocol-defined exclusion criteria may apply.
Contacts and Locations
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More Information
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| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT01263444 History of Changes |
| Other Study ID Numbers: | RDG-10-246, 2010-022948-21 |
| Study First Received: | December 17, 2010 |
| Last Updated: | May 2, 2013 |
| Health Authority: | France: Committee for the Protection of Personnes Austria: Ethikkommission Spain: Comité Ético de Investigación Clínica |
Additional relevant MeSH terms:
|
Glaucoma Ocular Hypertension Eye Diseases Timolol Maleic acid Brinzolamide Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Antihypertensive Agents Enzyme Inhibitors Carbonic Anhydrase Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013