Efficacy and Safety of Adding Azarga to Prostaglandin Monotherapy

Alcon

Status and phase

Completed

Phase 4

Conditions

Glaucoma

Treatments

Drug: Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00966576

SMA-08-22a

Details and patient eligibility

About

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.

Enrollment

47 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.