Patient Preference Comparison of AZARGA Versus COSOPT

Ocular Hypertension Clinical Trial

Official title:

Patient Preference Comparison of AZARGA Versus COSOPT in Patients With Open-Angle Glaucoma or Ocular Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340014
• Other study ID #: RDG-10-251
• Secondary ID: 2010-024244-15
• Status: Completed
• Phase: Phase 4
• First received: April 20, 2011
• Last updated: January 13, 2014
• Start date: September 2011
• Est. completion date: October 2012

Study information

• Verified date: January 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeGermany: Ethics CommissionItaly: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to assess patient preference regarding ocular comfort of AZARGA® compared to COSOPT® after one week instillation of each study medication.

Description:

At the Screening Visit, each intervention was instilled in one eye in a contralateral fashion to establish baseline ocular comfort prior to randomization. A 48-hour washout period separated the two treatment periods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of ocular hypertension, open-angle with or without pseudoexfoliation or pigment dispersion glaucoma in both eyes.

• On a stable regimen of intraocular pressure-lowering (IOP) medication within 30 days of Screening Visit.

• IOP considered safe (in the opinion of the Investigator) in both eyes in such a way that assures clinical stability of vision and the optic nerve throughout the study period.

• IOP between 19 and 35 millimeters mercury (mmHg) in at least one eye (study eye).

• Willing to discontinue the use of all other ocular drugs (prescribed and over-the-counter) prior to receiving the screening dose during the Screening Visit and for the entire course of the study.

• Able to follow instructions and willing and able to attend all study visits.

• Read, sign, and date an Ethics Committee reviewed and approved Informed Consent Form.

• 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 clinically significant in the opinion of the Principal Investigator.

• Best corrected visual acuity worse than 20/80 Snellen in either eye.

• Any abnormality preventing reliable applanation tonometry in either eye.

• Intraocular conventional surgery or laser surgery in either eye less than 3 months prior to the Screening Visit.

• Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the Investigator's best judgment.

• Progressive retinal or optic nerve disease from any cause.

• History of ocular herpes simplex.

• Severe allergic rhinitis or bronchial hypersensitivity that would preclude the safe administration of a topical beta-blocker.

• Bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.

• Women who are pregnant, lactating, or of childbearing potential and not using a reliable means of birth control.

• 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
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-Angle Glaucoma

Intervention

Drug:
• Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspension

• Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preferred Treatment	The participant completed a questionnaire on the Day 15 visit (ie, after administration of both study medications) consisting of a single preference question: "Thinking about the comfort of the two medications (1st and 2nd) that you took during this study, which medication do you prefer?" Preferred treatment is presented as a percentage.	At the end of both periods, Day 15	No
Secondary	Ocular Discomfort	Ocular discomfort was assessed by the participant 1 minute after instillation of the study medication. Ocular discomfort was rated on a 10-point scale (0=no discomfort, 9=substantial discomfort).	Day 7 of each period	No