Safety and Efficacy of Adding Azarga Adjunctive to Prostaglandin Therapy
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/30/2013 |
Start Date: | March 2011 |
End Date: | April 2013 |
Contact: | Alcon Call Center |
Phone: | 1-888-451-3937 |
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.
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.
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