Efficacy and Safety of Adding Azarga to Prostaglandin Monotherapy

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Brinzolamide; Maleic acid; Timolol

Criteria

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.