Efficacy and Safety of Adding Azarga to Prostaglandin Monotherapy

• Register: ClinicalTrials.gov
• Last refreshed on: 28 November 2016
• Main ID: NCT00966576
• Date of registration: 26/08/2009
• Prospective Registration: No
• Primary sponsor: Alcon Research
• Public title: Efficacy and Safety of Adding Azarga to Prostaglandin Monotherapy
• Scientific title: The Efficacy and Safety of Adding the Brinzolamide/Timolol Maleate Fixed Combination (Azarga®) to Prostaglandin Monotherapy
• Date of first enrolment: July 2009
• Target sample size: 47
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00966576
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Germany, United States

Key inclusion & exclusion 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.



Age minimum: 21 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Glaucoma

Intervention(s)

Drug: Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)

Primary Outcome(s)

The mean decrease in intraocular pressure (IOP) at 12 weeks from baseline [Time Frame: 12 weeks]

Secondary Outcome(s)

Safety as determined by visual acuity, biomicroscopy, adverse events, solicited symptom survey and treatment success [Time Frame: Week 4 and Week 12]

Secondary ID(s)

SMA-08-22a

Source(s) of Monetary Support

Please refer to primary and secondary sponsors