Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01111890
First received: April 26, 2010
Last updated: July 9, 2014
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Glaucoma
Ocular Hypertension
Drug: Azarga (brinzolamide 1% / timolol 0.5%)
Drug: Cosopt (dorzolamide 2% / timolol 0.5%)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean change in Intraocular Pressure (IOP) following 12 weeks of twice daily dosing [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of subjects with IOP ≤ 18 millimeters mercury (mmHg) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: April 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azarga
Azarga (brinzolamide 1% / timolol 0.5%)
Drug: Azarga (brinzolamide 1% / timolol 0.5%)
Dosed twice daily at 9:00 AM and 9:00 PM for 12 weeks
Active Comparator: Cosopt
Cosopt (dorzolamide 2% / timolol 0.5%)
Drug: Cosopt (dorzolamide 2% / timolol 0.5%)
Dosed twice daily at 9:00 AM and 9:00 PM for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01111890

Locations
Canada, Ontario
Mississauga, Ontario, Canada, L5L 1W8
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01111890     History of Changes
Other Study ID Numbers: SMA-09-17
Study First Received: April 26, 2010
Last Updated: July 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Brinzolamide
Dorzolamide
Timolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014