Patient Preference Comparison of AZARGA Versus COSOPT in Patients With Glaucoma

Glaucoma Clinical Trial

Official title:

Patient Preference Comparison of AZARGA Versus COSOPT After Single Doses in Patients With Open-Angled Glaucoma or Ocular Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01471158
• Other study ID #: SMA-09-18
• Status: Completed
• Phase: Phase 4
• First received: November 10, 2011
• Last updated: November 18, 2016
• Start date: September 2010
• Est. completion date: May 2011

Study information

• Verified date: November 2011
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Human Research Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Ocular Hypertension

Intervention

Drug:
• Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)
Brinzolamide/timolol maleate fixed combination, one drop instilled in one eye at baseline, followed by one drop instilled in each eye once in either first intervention period or second intervention period.
• Dorzolamide/timolol Maleate Fixed Combination (COSOPT)
Dorzolamide/timolol maleate fixed combination, one drop instilled in one eye at baseline, followed by one drop instilled in each eye once in either first intervention period or second intervention period.

Locations

Country	Name	City	State
Argentina	Centro Oftalmológico	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Argentina, 

References & Publications (1)

https://www.dovepress.com/preference-for-a-fixed-combination-of-brinzolamidetimolol-versus-dorzo-peer-reviewed-article-OPTH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discomfort	One drop of medication will be instilled in each eye. At one minute after instillation, subject will be given an Ocular Discomfort Scale and will record ocular discomfort on a questionnaire using a 10-point scale, with 0 being no discomfort and 09 being substantial discomfort.	One minute after instillation	No