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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

Page last updated: August 23, 2015

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