Comparison of the Efficacy of AZARGA® Versus COSOPT® in Patients With Open-Angled Glaucoma or Ocular Hypertension

Glaucoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01111890
• Other study ID #: SMA-09-17
• Status: Completed
• Phase: Phase 4
• First received: April 26, 2010
• Last updated: July 27, 2015
• Start date: April 2010
• Est. completion date: July 2011

Study information

• Verified date: January 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Subjects are dosed twice daily at 9AM and 9PM for 12 weeks. The primary efficacy variable is the mean change in Intraocular Pressure (IOP) from baseline to 12 weeks. Secondary efficacy variable: % IOP ≤ 18 millimeters mercury (mmHg). Exploratory endpoint: Ocular discomfort scale after first dose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Must be at least 18 years of age.

2. Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in at least one eye (study eye).

3. Must have 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.

4. Must be willing to discontinue the use of all other ocular hypotensive agents prior to receiving the assigned study drug at Visit 1, throughout the study period.

5. Must have an IOP of between 19 to 35 mmHg in at least one eye (which would be the study eye).

6. For the eyes not included in the study, the intraocular pressure should be able to be controlled on no pharmacologic therapy or on the study medicine alone.

Exclusion Criteria:

1. Known medical history of allergy, hypersensitivity or poor tolerance to any components of the preparations to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator.

2. Presence of other primary or secondary glaucoma not listed in inclusion criterion #2.

3. Any abnormality preventing reliable applanation tonometry in study eye(s).

4. Risk of visual field or visual acuity worsening due to participation in the study, in the investigator's best judgment.

5. Progressive retinal or optic nerve disease from any cause.

6. 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 Day 1 Visit or an anticipated change in the dosage during the course of the study.

7. 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.

8. Participation in any other investigational study within 30 days prior to Visit 1.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• Azarga (brinzolamide 1% / timolol 0.5%)
Dosed twice daily at 9:00 AM and 9:00 PM for 12 weeks
• Cosopt (dorzolamide 2% / timolol 0.5%)
Dosed twice daily at 9:00 AM and 9:00 PM for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in Intraocular Pressure (IOP) following 12 weeks of twice daily dosing		12 weeks	Yes
Secondary	Percentage of subjects with IOP = 18 millimeters mercury (mmHg)		12 weeks	Yes