A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Evening Dosing With Xalacom In Subjects With Glaucoma

NCT00159653 | Completed Phase 3

• 1 other identifier: A6641027
• Study Type: interventional
• Target: 500
• Locations: 2 countries
• Sites: 55

Brief Summary

To demonstrate statistical superiority of the combination of latanoprost and timolol to the individual therapy of latanoprost and timolol based on intraocular pressure measurements at 8 AM, 10 AM, 4 PM at weeks 2, 6 and 12.

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• The mean IOP measurements obtained in the study eye at each time point

Interventions

Xalacom DRUG

Xalatan DRUG

Timolol DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening

You may not qualify if:

• Closed/ barely open anterior chamber angle or history of acute angle closure glaucoma.
• History of ALT (Argon Laser Trabeculoplasty) or SLT(selective Laser) within 3 months prior to screening

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (55)

Pfizer Investigational Site

Phoenix, Arizona, 85032, United States

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Poway, California, 92064, United States

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Redding, California, 96002-2122, United States

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Redding, California, 96002, United States

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Danbury, Connecticut, 06810-4004, United States

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Cape Coral, Florida, 33904, United States

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Lakeland, Florida, 33805-2440, United States

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Ormond Beach, Florida, 32174, United States

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Tampa, Florida, 33603, United States

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Atlanta, Georgia, 30322, United States

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Atlanta, Georgia, 30342, United States

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Atlanta, Georgia, 30349, United States

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Morrow, Georgia, 30260, United States

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Homewood, Illinois, 60430, United States

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Overland Park, Kansas, 66213, United States

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Louisville, Kentucky, 40207, United States

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Shreveport, Louisiana, 71104, United States

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North Dartmouth, Massachusetts, 02747, United States

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Saint Joseph, Michigan, 49085, United States

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Lincoln, Nebraska, 68506, United States

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Omaha, Nebraska, 68198-5540, United States

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Newark, New Jersey, 07103-2499, United States

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Bethpage, New York, 11714-5701, United States

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New York, New York, 10029-6574, United States

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Charlotte, North Carolina, 28210, United States

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Charlotte, North Carolina, 28262, United States

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High Point, North Carolina, 27262, United States

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Matthews, North Carolina, 28105, United States

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Wilmington, North Carolina, 28403, United States

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Tulsa, Oklahoma, 74104, United States

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Cranberry Township, Pennsylvania, 16066, United States

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Pittsburgh, Pennsylvania, 15238-3103, United States

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Mt. Pleasant, South Carolina, 29464-3060, United States

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Mt. Pleasant, South Carolina, 29464, United States

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North Charleston, South Carolina, 29406, United States

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Memphis, Tennessee, 38119, United States

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Amarillo, Texas, 79106, United States

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Houston, Texas, 77030, United States

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Calgary, Alberta, T2T 5R6, Canada

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Nanaimo, British Columbia, V9R 5B6, Canada

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Moncton, New Brunswick, E1C 2N7, Canada

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Saint John, New Brunswick, E2L 1G3, Canada

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Saint John, New Brunswick, E2L 4W3, Canada

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Bridgewater, Nova Scotia, B4V 3N2, Canada

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Barrie, Ontario, L4M 4S5, Canada

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Markham, Ontario, L6B 1A1, Canada

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Mississauga, Ontario, L5A 4E4, Canada

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Oakville, Ontario, L6H 3P1, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Toronto, Ontario, M5B 1W8, Canada

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Toronto, Ontario, M6H 2H1, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Montreal, Quebec, H1V 1G5, Canada

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Saskatoon, Saskatchewan, S7K 0M7, Canada

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Saskatoon, Saskatchewan, S7K 3H3, Canada

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Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Xalacom; Latanoprost; Timolol

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: July 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: February 21, 2021

Record last verified: 2012-10

Locations

US (38); CA (17)