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A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2%

Information source: Alcon Research
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Open-angle Glaucoma; Ocular Hypertension

Intervention: Brinzolamide / Brimonidine Fixed Combination (Drug); Brinzolamide (Drug); Brimonidine (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Alcon Research

Overall contact:
Alcon Call Center, Phone: 1-888-451-3937, Email: medical.information@alconlabs.com

Summary

This is a parallel group, randomized, multicenter study evaluating the comfort of Brinzolamide 1% / Brimonidine 0. 2% Fixed Combination, Brinzolamide 1% and Brimonidine 0. 2%

Clinical Details

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Mean ocular discomfort of each treatment

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with a diagnosis of either open angle glaucoma (OAG) or ocular hypertension

(OHT) who are currently controlled, in the opinion of the Investigator2) Non-contact lens wearers

Exclusion Criteria:

- Schaffer angle Grade < 2 as measured by gonioscopy within 1 year of screening visit

(extreme narrow angle with complete or partial closure)

- Patients who are unable to discontinue use of other topical ocular medications,

including OTC medications for the duration of the study

- Any corneal conditions that may be causing significant hyperalgesia or hypoalgesia

- Acute or chronic ocular allergies (i. e., seasonal allergic conjunctivitis (SAC) and

perennial allergic conjunctivitis (PAC))

- Chronic or recurrent inflammatory ocular disease (i. e., scleritis, uveitis, herpes

keratitis)

- Ocular trauma within the past 6 months

- Ocular infection or inflammation within the past 3 months

- Intra-ocular surgery within the past 6 months

- Ocular laser surgery within the past 3 months

- Cup/disc ratio > 0. 8 (horizontal or vertical measurement)

- Severe central visual field loss as determined by visual field testing within 6

months of the Screening Visit

- Hypersensitivity to α-adrenergic agonist drugs, topical or oral carbonic anhydrase

inhibitors (CAIs), sulfonamide derivatives, or any component of the study medications in the opinion of the Investigator

- Patients who were on another investigational agent within 30 days prior to Visit 1

- History of active, severe, unstable or uncontrolled cardiovascular (e. g. coronary

insufficiency, hypertension, Raynaud's phenomenon, orthostatic hypotension, thromboangiitis obliterans), cerebrovascular (e. g. cerebral insufficiency), hepatic, or renal disease that would preclude the safe administration of a topical α-adrenergic agonist or CAI in the opinion of the investigator

- History of or current evidence of severe illness or any other conditions which would

make the patient, in the opinion of the investigator, unsuitable for the study

- Patients with recent (within 4 weeks of the Screening Visit) use of high-dose (>1 g

daily) salicylate therapy

- Concurrent use of monoamine oxidase inhibitors (MAOI)

Locations and Contacts

Alcon Call Center, Phone: 1-888-451-3937, Email: medical.information@alconlabs.com

Contact Alcon Call Center for Trial Locations, Fort Worth, Texas 76134, United States; Recruiting
Additional Information

Starting date: September 2011
Last updated: October 19, 2011

Page last updated: December 08, 2011

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