Efficacy and Safety of Adding Azarga to Prostaglandin Monotherapy

NCT00966576 | Completed Phase 4

• 1 other identifier: SMA-08-22a
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glaucoma

Keywords

Glaucoma; IOP; AZARGA

Outcome Measures

Primary Outcomes (1)

• The mean decrease in intraocular pressure (IOP) at 12 weeks from baseline

  12 weeks

Secondary Outcomes (1)

• Safety as determined by visual acuity, biomicroscopy, adverse events, solicited symptom survey and treatment success

  Week 4 and Week 12

Study Arms (1)

Brinzolamide/Timolol Maleate Fixed Combination

EXPERIMENTAL

Drug: Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)

Interventions

Brinzolamide/Timolol Maleate Fixed Combination (AZARGA) DRUG

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

Also known as: AZARGA

Brinzolamide/Timolol Maleate Fixed Combination

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign Informed Consent.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Unknown Facility

Mainz, 55101, Germany

Location

Related 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. Epub 2011 Dec 9.

  PMID: 22205835 RESULT

MeSH Terms

Conditions

Glaucoma

Interventions

brinzolamide; Azarga

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2009
• First Posted: August 27, 2009
• Study Start: July 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: November 21, 2016

Record last verified: 2012-04

Locations

DE (1)