Safety and Efficacy of Adding AZARGA® Adjunctive to Prostaglandin Therapy

NCT01263444 | Completed Phase 4 Results

• 2 other identifiers: RDG-10-2462010-022948-21
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to evaluate the safety and efficacy of adding AZARGA® as a single agent to prostaglandin monotherapy in patients with either ocular hypertension or primary open-angle glaucoma.

Conditions

Glaucoma; Ocular Hypertension

Keywords

AZARGA®; Open angle glaucoma; Prostaglandin Therapy

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Intraocular Pressure (IOP) at Week 12

  IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. Only one eye (study eye) contributed to the mean.

  Baseline, Week 12

Secondary Outcomes (3)

• Mean Change From Baseline in IOP Per Prostaglandin Group at Week 12

  Baseline, Week 12

• Mean Change From Baseline in IOP at Week 4

  Baseline, Week 4

• Percentage of Patients Reaching the Target IOP (≤ 18 mmHg)

  Week 12

Study Arms (1)

Azarga

EXPERIMENTAL

Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.

Drug: Brinzolamide 1% / timolol 0.5% Fixed Combination; Drug: Habitual prostaglandin monotherapy

Interventions

Brinzolamide 1% / timolol 0.5% Fixed Combination DRUG

Also known as: AZARGA®

Azarga

Habitual prostaglandin monotherapy DRUG

Topical ocular therapy used daily as prescribed

Also known as: Latanoprost, Travoprost, Bimatoprost, Tafluprost

Azarga

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of ocular hypertension, primary open angle (including pigment dispersion) glaucoma in both eyes.
• 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 study period.
• Treated with, and in the Investigator's judgment demonstrated an inadequate response to, prostaglandin monotherapy for a minimum of 4 weeks at Visit 1. Last dose of prostaglandin instilled correctly to put patient within the dosing cycle at Visit 1.
• At Visit 1, have an IOP of ≥ 20 mmHg in at least one eye and ≤ 35 mmHg in both eyes treated with prostaglandin monotherapy.
• Best corrected visual acuity of 1.0 LogMAR or better in each eye.
• In any eye not qualifying as a study eye, IOP should be able to be controlled on no pharmacologic therapy or on prostaglandin monotherapy alone.
• Willing to sign an informed consent form.
• Able to follow instructions and willing and able to attend required study visits.

You may not qualify if:

• Known medical history of allergy, hypersensitivity or poor tolerance to any component of AZARGA® that is deemed clinically significant in the opinion of the investigator.
• A history of, or at risk for uveitis or cystoid macular edema (CME).
• History of ocular herpes simplex.
• Corneal dystrophies in either eye.
• Concurrent infectious/non infectious conjunctivitis, keratitis or uveitis in either eye (excluding Blepharitis or non-clinically significant conjunctival hyperemia).
• Intraocular conventional surgery or laser surgery in study eye(s) less than 3 months prior to Visit 1.
• Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
• Progressive retinal or optic nerve disease from any cause apart from glaucoma.
• Use of systemic medications known to affect IOP (e.g. oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for 7 days prior to Visit 1 or an anticipated change in the dosage during the course of the study.
• Use of corticosteroids (oral, topical ocular or nasal) within 30 days of Visit 1 and during the course of the study.
• Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
• History of severe allergic rhinitis.
• A condition, which in the opinion of the principal investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject.
• Use of any systemic carbonic anhydrase inhibitors (CAI) (e.g. methazolamide \[Neptazane\], acetazolamide \[Diamox\]).
• Severely impared renal function.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle

Interventions

brinzolamide; Timolol; Azarga; Latanoprost; Travoprost; Bimatoprost; tafluprost

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Cloprostenol; Amides

Limitations and Caveats

A single-arm, non-randomized study somewhat limits interpretation of efficacy results. A 3-month duration does not allow for long-term safety conclusions; however, data obtained at V2 and V3 did not vary much, indicating a steady state at Month 1.

Results Point of Contact

• Title: Doug Hubatsch, Global Brand Leader, Medical Affairs
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Severine Durier, Pharm. D

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: December 17, 2010
• First Posted: December 20, 2010
• Study Start: March 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 20, 2014
• Results First Posted: May 19, 2014

Record last verified: 2014-05