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

Use our guide to learn which trials are right for you!


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.
We found this trial at
1
site
Fort Worth, Texas 76134
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials