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. )

Tracking Information

• First Submitted Date: February 16, 2009
• First Posted Date: February 19, 2009
• Last Update Posted Date: February 2, 2021
• Study Start Date: January 2002
• Actual Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 17, 2009)

• To compare the IOP reducing effect of latanoprost (Xalatan) versus travoprost (Travatan) versus bimatoprost (Lumigan) over a twelve-week period. [ Time Frame: 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 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 17, 2009)

• To study the safety variables within and between all treatment groups over 12 weeks [ Time Frame: 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 ]
• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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).
• Brief Summary: Compare the IOP lowering properties of latanoprost, travoprost and bimatoprost
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment

Condition

• Glaucoma
• Ocular Hypertension

Intervention

• Drug: latanoprost 0.005% ophthalmic solution
  One drop in the evening in the affected eye(s) at 8:00pm
  Other Name: Xalatan
• Drug: Travoprost 004% sterile ophthalmic solution
  One drop in the evening in the affected eye(s) at 8:00pm
  Other Name: Travatan
• Drug: Bimatoprost .03% sterile ophthalmic solution
  One drop in the evening in the affected eye(s) at 8:00pm
  Other Name: Lumigan

Study Arms

• Active Comparator: Latanoprost
  Intervention: Drug: latanoprost 0.005% ophthalmic solution
• Active Comparator: Travoprost
  Intervention: Drug: Travoprost 004% sterile ophthalmic solution
• Active Comparator: Bimatoprost
  Intervention: Drug: Bimatoprost .03% sterile ophthalmic solution

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 17, 2009): 375
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: August 2002
• Actual Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00847483
• Other Study ID Numbers: XALA-0091-157; A6111081
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
• Study Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Collaborators: Not Provided

Investigators

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

• PRS Account: Pfizer
• Verification Date: February 2009