Patient Preference Comparison of AZARGA Versus COSOPT in Patients With Glaucoma
Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma
Intervention: Brinzolamide/Timolol Maleate Fixed Combination (AZARGA) (Drug); Dorzolamide/timolol Maleate Fixed Combination (COSOPT) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Alcon Research Official(s) and/or principal investigator(s): Abayomi Ogundele, PharmD, Study Director, Affiliation: Alcon Research
Summary
The purpose of this study is to assess patient preference of AZARGA® compared to COSOPT®
after a single drop of each medication is administered to both eyes, in patients with
open-angled glaucoma or ocular hypertension.
Clinical Details
Official title: Patient Preference Comparison of AZARGA Versus COSOPT After Single Doses in Patients With Open-Angled Glaucoma or Ocular Hypertension
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Discomfort
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion
glaucoma in both eyes.
- On a stable regimen intraocular pressure (IOP) lowering medication within 30 days of
screening visit.
- IOP considered to be safe (in the opinion of the investigator) in both eyes in such a
way that should assure clinical stability of vision and the optic nerve throughout
the study period.
- Willing to discontinue use of all other ocular drugs (prescribed and
over-the-counter) prior to receiving the screening dose during Screening Visit and
for the course of the study.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Known medical history of allergy, hypersensitivity, or poor tolerance to any
component of the preparations to be used in this study that is deemed clinical
significant in the opinion of the Principal Investigator.
- Corneal dystrophies in either eye.
- Risk of visual field or visual acuity worsening as a consequence of participating in
this study, in the investigator's best judgment.
- Bronchial asthma or a history of bronchial asthma, or severe chronic obstructive
pulmonary disease that would preclude the safe administration of a topical
beta-blocker.
- History of severe allergic rhinitis.
- Participation in any other investigational study within 30 days prior to the
Screening/Baseline Visit.
- Other protocol-defined exclusion criteria may apply.
Locations and Contacts
Centro Oftalmológico, Buenos Aires 1425, Argentina
Additional Information
Starting date: September 2010
Last updated: July 9, 2014
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