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XLT: 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

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00847483
Collaborator
(none)
375
Enrollment
40
Locations
3
Arms
7
Duration (Months)
9.4
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Compare the IOP lowering properties of latanoprost, travoprost and bimatoprost

Condition or Disease Intervention/Treatment Phase
  • 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
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 :
Jan 1, 2002
Actual Primary Completion Date :
Aug 1, 2002
Actual Study Completion Date :
Aug 1, 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 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

    		•

    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. [12 weeks]

    2. The mean change since baseline of Week 12 IOP measured at the time of peak (8:00AM) drug effect. [12 weeks]

    Secondary Outcome Measures

    1. To study the safety variables within and between all treatment groups over 12 weeks [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. [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 [12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Site City State Country Postal Code
    1 Pfizer Investigational Site Bellflower California United States 90706
    2 Pfizer Investigational Site Inglewood California United States 90301
    3 Pfizer Investigational Site San Diego California United States 92103
    4 Pfizer Investigational Site San Diego California United States 92116
    5 Pfizer Investigational Site San Francisco California United States 94115
    6 Pfizer Investigational Site Gainesville Florida United States 32610
    7 Pfizer Investigational Site Lakeland Florida United States 33805
    8 Pfizer Investigational Site Ormond Beach Florida United States 32174
    9 Pfizer Investigational Site Atlanta Georgia United States 30339
    10 Pfizer Investigational Site Bloomingdale Illinois United States 60108
    11 Pfizer Investigational Site Evansville Indiana United States 47710
    12 Pfizer Investigational Site Louisville Kentucky United States 40207
    13 Pfizer Investigational Site Louisville Kentucky United States 40217
    14 Pfizer Investigational Site Shreveport Louisiana United States 771104
    15 Pfizer Investigational Site Bangor Maine United States 04401
    16 Pfizer Investigational Site Kansas City Missouri United States 64111
    17 Pfizer Investigational Site Kansas City Missouri United States 64114
    18 Pfizer Investigational Site Omaha Nebraska United States 68198-5540
    19 Pfizer Investigational Site Las Vegas Nevada United States 89104
    20 Pfizer Investigational Site Bloomfield New Jersey United States 07003
    21 Pfizer Investigational Site Willingboro New Jersey United States 08046
    22 Pfizer Investigational Site Charlotte North Carolina United States 28210
    23 Pfizer Investigational Site Winston-Salem North Carolina United States 27103
    24 Pfizer Investigational Site Streetsboro Ohio United States 44241
    25 Pfizer Investigational Site Oklahoma City Oklahoma United States 73104
    26 Pfizer Investigational Site Tulsa Oklahoma United States 74104
    27 Pfizer Investigational Site Pittsburgh Pennsylvania United States 15224
    28 Pfizer Investigational Site Charleston South Carolina United States 29412
    29 Pfizer Investigational Site Charleston South Carolina United States 29414
    30 Pfizer Investigational Site Charleston South Carolina United States 29425
    31 Pfizer Investigational Site Maryville Tennessee United States 37803
    32 Pfizer Investigational Site Memphis Tennessee United States 38119
    33 Pfizer Investigational Site Dallas Texas United States 75231
    34 Pfizer Investigational Site El Paso Texas United States 79902
    35 Pfizer Investigational Site Houston Texas United States 77025
    36 Pfizer Investigational Site Layton Utah United States 84041
    37 Pfizer Investigational Site Norfolk Virginia United States 23505
    38 Pfizer Investigational Site Norfolk Virginia United States 23507
    39 Pfizer Investigational Site Virginia Beach Virginia United States 23456
    40 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    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:
    Feb 19, 2009
    Last Update Posted:
    Feb 2, 2021
    Last Verified:
    Feb 1, 2009
    Keywords provided by 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
    Bimatoprost
    Travoprost
    Pharmaceutical Solutions
    Latanoprost
    Ophthalmic Solutions

    Study Results

    No Results Posted as of Feb 2, 2021