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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

  Show 40 Study Locations
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 25, 2014