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)

February 1, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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).

Compare the IOP lowering properties of latanoprost, travoprost and bimatoprost

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

375

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • 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
        • Pfizer Investigational Site
    • Florida
      • Gainesville, Florida, United States, 32610
        • Pfizer Investigational Site
      • Lakeland, Florida, United States, 33805
        • Pfizer Investigational Site
      • Ormond Beach, Florida, United States, 32174
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30339
        • Pfizer Investigational Site
    • Illinois
      • Bloomingdale, Illinois, United States, 60108
        • Pfizer Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47710
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40207
        • Pfizer Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States, 771104
        • Pfizer Investigational Site
    • Maine
      • Bangor, Maine, United States, 04401
        • Pfizer Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Pfizer Investigational Site
      • Kansas City, Missouri, United States, 64114
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68198-5540
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89104
        • Pfizer Investigational Site
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Pfizer Investigational Site
      • Willingboro, New Jersey, United States, 08046
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Pfizer Investigational Site
    • Ohio
      • Streetsboro, Ohio, United States, 44241
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, United States, 74104
        • Pfizer Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Pfizer Investigational Site
      • Charleston, South Carolina, United States, 29412
        • Pfizer Investigational Site
      • Charleston, South Carolina, United States, 29414
        • Pfizer Investigational Site
    • Tennessee
      • Maryville, Tennessee, United States, 37803
        • Pfizer Investigational Site
      • Memphis, Tennessee, United States, 38119
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Pfizer Investigational Site
      • El Paso, Texas, United States, 79902
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77025
        • Pfizer Investigational Site
    • Utah
      • Layton, Utah, United States, 84041
        • Pfizer Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Pfizer Investigational Site
      • Norfolk, Virginia, United States, 23505
        • Pfizer Investigational Site
      • Virginia Beach, Virginia, United States, 23456
        • Pfizer Investigational Site
    • Washington
      • Wenatchee, Washington, United States, 98801
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • Xalatan
Active Comparator: Travoprost
Drug: Travoprost 004% sterile ophthalmic solution
One drop in the evening in the affected eye(s) at 8:00pm
Other Names:
  • Travatan
Active Comparator: Bimatoprost
Drug: Bimatoprost .03% sterile ophthalmic solution
One drop in the evening in the affected eye(s) at 8:00pm
Other Names:
  • Lumigan

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
To study the safety variables within and between all treatment groups over 12 weeks
Time Frame: 12 weeks
12 weeks
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
12 weeks
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

August 1, 2002

Study Completion (Actual)

August 1, 2002

Study Registration Dates

First Submitted

February 16, 2009

First Submitted That Met QC Criteria

February 17, 2009

First Posted (Estimate)

February 19, 2009

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XALA-0091-157
  • A6111081

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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