Patient Preference Comparison of Azarga versus Cosopt, in Patients with Open-Angled Glaucoma or Ocular Hypertension.

• Conditions: Open-Angle Glaucoma and Ocular Hypertension; MedDRA version: 13.1Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2010-024244-15-GB
• Lead Sponsor: ALCON Research Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-11
• Last Update Posted: 5 November 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

1.Must be at least 18 years of age.
2.Must have a clinical diagnosis of ocular hypertension, open-angle with or without pseudoexfoliation or pigment dispersion glaucoma in both eyes.
3.Must be on a stable regimen IOP lowering medication within 30 days of Screening Visit.
4.Must have 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.
5.Must have an IOP of between 19 to 35 mmHg in at least one eye (which would be the study eye).
6.Must be 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.
7.Must be able to follow instructions and be willing and able to attend all study visits.
8.An Ethics Committee reviewed and approved (for use in this study) informed consent form must be read, signed, and dated by the participating subject, as well as signed and dated by the individual (Principal Investigator or Sub-investigator) obtaining the informed consent, before conducting the Screening Visit and prior to initiation of study procedures.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 72
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1.Known history of hypersensitivity 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.Best corrected visual acuity that is worse than 20/80 Snellen in either eye.
3.Any abnormality preventing reliable applanation tonometry in either eye.
4.Corneal dystrophies.
5.Any opacity or subject uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber of either eye.
6.Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
7.Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit.
8.Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator’s best judgment.
9.Progressive retinal or optic nerve disease from any cause.
10.History of ocular herpes simplex.
11.History of hyperchloremic acidosis.
12.Severe allergic rhinitis or bronchial hypersensitivity that would preclude the safe use of a topical beta-blocker.
13.Severe renal impairment
14.Use of any topical carbonic anhydrase inhibitor (single or fixed combination) within a year of the Screening Visit.
15.Bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
16.Sinus bradycardia, second- or third-degree atrioventricular block, overt cardiac failure, or cardiogenic shock that would preclude the safe administration of a topical beta-blocker.
17.Any clinically significant, serious, or severe medical or psychiatric condition.
18.Women of childbearing potential not using reliable means of birth control. A reliable effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed.
19.Women who are pregnant or lactating
20.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.
21.Participation in any other investigational study within 30 days prior to the Screening Visit.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to assess patient preference of AZARGA® compared to COSOPT® after one week instillation of each study medication is administered to both eyes, in patients with open-angle glaucoma or ocular hypertension.;Secondary Objective: Secondary efficacy measure is to assess differences in the ocular discomfort of the study medications.;Primary end point(s): The primary efficacy parameter is the preferred treatment indicated on the Subject Preference Questionnaire after patients have been dosed with both study medication on Day 15.;Timepoint(s) of evaluation of this end point: Day 15

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary efficacy parameter is assessed by results from the Ocular Discomfort Scale after patients have been dosed with each study medication on Day 7 and 15.;Timepoint(s) of evaluation of this end point: Day 7 and Day 15