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)

• ClinicalTrials.gov Identifier: NCT00847483
• Recruitment Status: Completed
• First Posted: February 19, 2009
• Last Update Posted: February 2, 2021
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Information provided by (Responsible Party): Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Description

Brief Summary:

Compare the IOP lowering properties of latanoprost, travoprost and bimatoprost

Condition or disease	Intervention/treatment	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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 375 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (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).
• Study Start Date: January 2002
• Actual Primary Completion Date: August 2002
• Actual Study Completion Date: August 2002

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. To compare the IOP reducing effect of latanoprost (Xalatan) versus travoprost (Travatan) versus bimatoprost (Lumigan) over a twelve-week period. [ Time Frame: 12 weeks ]
2. The mean change since baseline of Week 12 IOP measured at the time of peak (8:00AM) drug effect. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :

1. To study the safety variables within and between all treatment groups over 12 weeks [ Time Frame: 12 weeks ]
2. 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 ]
3. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, California

Pfizer Investigational Site

Bellflower, California, United States, 90706

Pfizer Investigational Site

Inglewood, California, United States, 90301

Pfizer Investigational Site

San Diego, California, United States, 92103

Pfizer Investigational Site

San Diego, California, United States, 92116

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, 40207

Pfizer Investigational Site

Louisville, Kentucky, United States, 40217

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, 64111

Pfizer Investigational Site

Kansas City, Missouri, United States, 64114

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, 29414

Pfizer Investigational Site

Charleston, South Carolina, United States, 29425

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's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00847483
• Other Study ID Numbers: XALA-0091-157; A6111081
• First Posted: February 19, 2009
• Last Update Posted: February 2, 2021
• Last Verified: February 2009

Keywords provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):

glaucoma; ocular hypertension; latanoprost; travoprost; bimatoprost

Additional relevant MeSH terms:

Glaucoma; Ocular Hypertension; Hypertension; Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Bimatoprost; Travoprost; Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions; Antihypertensive Agents