A Comparison of Azopt Versus Placebo Added to Xalatan in Patients With Elevated IOP on a Prostaglandin

This study is currently recruiting participants.

Verified by Alcon Research, September 2008

First Received: September 24, 2008 No Changes Posted

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00759941

Purpose

Assess safety and efficacy of transitioning uncontrolled glaucoma patients currently on Xalatan to adding either Azopt or Placebo TID.

Condition	Intervention	Phase
Glaucoma	Drug: AZOPT Solution Drug: Placebo Eye Drops	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Tetrahydrozoline Azopt Tetrahydrozoline hydrochloride

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Intraocular Pressure [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Estimated Enrollment:	90
Study Start Date:	October 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Placebo Comparator Placebo	Drug: Placebo Eye Drops Placebo Eye Drop Solution
1: Active Comparator AZOPT Solution	Drug: AZOPT Solution Eye Drops

Eligibility

Criteria

Inclusion Criteria:

Unilateral or bilateral primary open angle glaucoma, ocular hypertension or pseudoexfoliation syndrome
IOP > 18mm Hg (mean diurnal) and less than 32 mm Hg

Exclusion:

Previous intraocular surgery, Except uncomplicated clear cornea phacoemulsification or argon laser trabeculoplasty
Argon laser trabeculoplasty or phacoemulsification within the last 3 months
Central corneal thickness outside the 500 - 600 (inclusive) micron range as measured by ultrasonic pachymetry
Ocular or periocular inflammation within 3 months prior to study (except blepharitis related or seasonal allergic conjunctivitis)
History of uveitis or previous intraocular inflammation (other than post-operatively)
Hypersensitivity to sulfa, or benzalkonium chloride
History of use of any steroids for over 1 week within 3 months of screening or likely need for any corticosteroids during the study (except inhaled, nasal or topical non-ocular)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00759941

Contacts

Contact: Alcon Call Center

1-888-451-3937

Locations

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

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Responsible Party:	Study Director ( Mark Jasek )
Study ID Numbers:	SMA-07-08
Study First Received:	September 24, 2008
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00759941 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alcon Research:

Glaucoma

Study placed in the following topic categories:

Brinzolamide
Glaucoma
Eye Diseases
Tetrahydrozoline

Latanoprost
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Glaucoma
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on September 11, 2009