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Comparison of Latanoprost With Travoprost and Bimatoprost in Patients With Elevated IOP. A 12-Weeks, Masked Evaluator, Phase IV Multi-Center Study in the US (XLT)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00847483
First received: February 16, 2009
Last updated: February 17, 2009
Last verified: February 2009
  Purpose

Compare the IOP lowering properties of latanoprost, travoprost and bimatoprost


Condition Intervention Phase
Glaucoma
Ocular Hypertension
Drug: latanoprost 0.005% ophthalmic solution
Drug: Travoprost 004% sterile ophthalmic solution
Drug: Bimatoprost .03% sterile ophthalmic solution
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Comparison of Latanoprost (Xalatan) With Travoprost (Travatan) and Bimatoprost (Lumigan) in Patients With Elevated Intraocular Pressure. A Twelve-Week, Masked Evaluator, Phase IV, Multicenter Study in the United States. (Xalatan vs Travatan vs Lumigan).

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To compare the IOP reducing effect of latanoprost (Xalatan) versus travoprost (Travatan) versus bimatoprost (Lumigan) over a twelve-week period. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The mean change since baseline of Week 12 IOP measured at the time of peak (8:00AM) drug effect. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To study the safety variables within and between all treatment groups over 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The mean change since baseline of Week 12 IOP measured at the time of trough (8:00PM) drug effect. The mean percentage change since baseline of diurnal IOP at Week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The mean change since baseline of Week 12 IOP measured at the times of peak (8:00AM) and trough (8:00PM) drug effects evaluated by race. The percentage of patient withdrawals from the study [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 375
Study Start Date: January 2002
Study Completion Date: August 2002
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Latanoprost Drug: latanoprost 0.005% ophthalmic solution
One drop in the evening in the affected eye(s) at 8:00pm
Other Name: Xalatan
Active Comparator: Travoprost Drug: Travoprost 004% sterile ophthalmic solution
One drop in the evening in the affected eye(s) at 8:00pm
Other Name: Travatan
Active Comparator: Bimatoprost Drug: Bimatoprost .03% sterile ophthalmic solution
One drop in the evening in the affected eye(s) at 8:00pm
Other Name: Lumigan

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unilateral or bilateral primary open angle glaucoma (POAG), exfoliative glaucoma, pigmentary glaucoma or ocular hypertension (glaucoma is defined as either visual fields defect or glaucomatous changes of the optic nerve head in association with elevated intraocular pressure. Ocular hypertension is defined as IOP ≥ 21 mmHg at diagnosis).
  • Is currently receiving (at the screen visit) or has received topical monotherapy or dual therapy (within the past 6 months) for POAG or ocular hypertension.
  • Required washout periods are 4 weeks for -adrenergic antagonists, prostaglandin analogues (including latanoprost, unoprostone, travoprost and bimatoprost) and 2 weeks for adrenergic agonists, and 5 days for cholinergic agonists and carbonic anhydrase inhibitors, prior to the baseline visit.
  • Mean 8 AM IOP ≥ 23 mmHg at the baseline visit for all patients. Patients should be assigned treatment only after the 8 PM IOP is obtained.
  • Visual acuity (best corrected) equal to or better than 20/200 (Snellen). ETDRS charts may be used and converted to Snellen units.
  • Informed Consent: Signed Informed Consent is obtained at the screen visit.
  • Able to adhere to treatment/visit planUnilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
  • Open angle glaucoma appearing more than 6 months after cataract surgery is recognized as primary open angle glaucoma. (individuals requiring treatment bilaterally must fulfill eligibility criteria for both eyes.)
  • IOP of 22mmHg or higher obtained during the pre-study period.

Exclusion Criteria:

Ocular conditions

  • Closed/barely open anterior chamber angle or history of acute angle closure. (Patients who are diagnosed with POAG after a successful peripheral iridotomy may be enrolled).
  • History of ALT (Argon Laser Trabeculoplasty) within 3 months prior to the screen visit (the unlasered eye may be enrolled as the study eye).
  • History of any ocular filtering surgical intervention (the unfiltered eye may be enrolled as the study eye).
  • Ocular surgery (on the globe of the eye only), or inflammation/infection within 3 months prior to screen visit. (Applies to both fellow and study eyes.)
  • Hypersensitivity to benzalkonium chloride or to any other component in latanoprost (Xalatan), travoprost (Travatan) or bimatoprost (Lumigan).
  • Other abnormal ocular conditions or symptoms preventing the patient from entering the study, in the investigator's clinical judgement.

Other conditions

  • Use of systemic medication known to affect IOP (i.e., alpha-adrenergic agonists, beta-adrenergic antagonists, calcium channel blockers, ACE inhibitors and/or angiotensin II receptor blockers, or corticosteroids), unless the patient and the medication dosage have been stable for three months prior to the screen visit and the dosage is not expected to change during the study.

Women

  • Women of childbearing potential (WOCBP) who are not using contraceptive methods. Women of childbearing potential are defined as women who are not surgically sterile or not postmenopausal (at least 12 months without a menstrual period). Contraception is defined as abstinence, having a vasectomized partner, or the ongoing use of approved oral, injectable or implanted contraceptives, a barrier method, or an IUD.
  • Pregnancy. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at the screen visit and baseline visit.
  • Nursing mothers General
  • Use of any investigational medication within 30 days prior to screen visit.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00847483

  Hide Study Locations
Locations
United States, California
Pfizer Investigational Site
Belleflower, California, United States, 90706
Pfizer Investigational Site
Inglewood, California, United States, 90301
Pfizer Investigational Site
San Diego, California, United States, 92116
Pfizer Investigational Site
San Diego, California, United States, 92103
Pfizer Investigational Site
San Francisco, California, United States, 94115
United States, Florida
Pfizer Investigational Site
Gainesville, Florida, United States, 32610
Pfizer Investigational Site
Lakeland, Florida, United States, 33805
Pfizer Investigational Site
Ormond Beach, Florida, United States, 32174
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30339
United States, Illinois
Pfizer Investigational Site
Bloomingdale, Illinois, United States, 60108
United States, Indiana
Pfizer Investigational Site
Evansville, Indiana, United States, 47710
United States, Kentucky
Pfizer Investigational Site
Louisville, Kentucky, United States, 40217
Pfizer Investigational Site
Louisville, Kentucky, United States, 40207
United States, Louisiana
Pfizer Investigational Site
Shreveport, Louisiana, United States, 771104
United States, Maine
Pfizer Investigational Site
Bangor, Maine, United States, 04401
United States, Missouri
Pfizer Investigational Site
Kansas City, Missouri, United States, 64114
Pfizer Investigational Site
Kansas City, Missouri, United States, 64111
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68198-5540
United States, Nevada
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89104
United States, New Jersey
Pfizer Investigational Site
Bloomfield, New Jersey, United States, 07003
Pfizer Investigational Site
Willingboro, New Jersey, United States, 08046
United States, North Carolina
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28210
Pfizer Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Pfizer Investigational Site
Streetsboro, Ohio, United States, 44241
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73104
Pfizer Investigational Site
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
Pfizer Investigational Site
Charleston, South Carolina, United States, 29412
Pfizer Investigational Site
Charleston, South Carolina, United States, 29425
Pfizer Investigational Site
Charleston, South Carolina, United States, 29414
United States, Tennessee
Pfizer Investigational Site
Maryville, Tennessee, United States, 37803
Pfizer Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75231
Pfizer Investigational Site
El Paso, Texas, United States, 79902
Pfizer Investigational Site
Houston, Texas, United States, 77025
United States, Utah
Pfizer Investigational Site
Layton, Utah, United States, 84041
United States, Virginia
Pfizer Investigational Site
Norfolk, Virginia, United States, 23505
Pfizer Investigational Site
Norfolk, Virginia, United States, 23507
Pfizer Investigational Site
Virginia Beach, Virginia, United States, 23456
United States, Washington
Pfizer Investigational Site
Wenatchee, Washington, United States, 98801
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00847483     History of Changes
Other Study ID Numbers: XALA-0091-157, A6111081
Study First Received: February 16, 2009
Last Updated: February 17, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
glaucoma
ocular hypertension
latanoprost
travoprost
bimatoprost

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Bimatoprost
Cloprostenol
Latanoprost
Ophthalmic Solutions
Pharmaceutical Solutions
Travoprost
Antihypertensive Agents
Cardiovascular Agents
Contraceptive Agents
Contraceptive Agents, Female
Luteolytic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014