Efficacy and Safety of Adding Azarga to Prostaglandin Monotherapy

Glaucoma Clinical Trial

Official title:

The Efficacy and Safety of Adding the Brinzolamide/Timolol Maleate Fixed Combination (Azarga®) to Prostaglandin Monotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00966576
• Other study ID #: SMA-08-22a
• Status: Completed
• Phase: Phase 4
• First received: August 26, 2009
• Last updated: November 18, 2016
• Start date: July 2009
• Est. completion date: August 2010

Study information

• Verified date: April 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)
1 drop of study medication into the study eye(s) beginning the evening of Visit 1 and continuing twice daily (morning and evening) for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Lorenz K, Rosbach K, Matt A, Pfeiffer N. Addition of a fixed combination of brinzolamide 1%/timolol 0.5% to prostaglandin monotherapy in patients with glaucoma or ocular hypertension. Clin Ophthalmol. 2011;5:1745-50. doi: 10.2147/OPTH.S25987. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean decrease in intraocular pressure (IOP) at 12 weeks from baseline		12 weeks	No
Secondary	Safety as determined by visual acuity, biomicroscopy, adverse events, solicited symptom survey and treatment success		Week 4 and Week 12	Yes