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

NCT00847483

Last updated date
Study Location
Pfizer Investigational Site
Belleflower, California, 90706, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Glaucoma, Ocular Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Glaucoma
  • Ocular Hypertension
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 17, 2009)
375
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2002
Actual Primary Completion Date August 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00847483
Other Study ID Numbers  ICMJE XALA-0091-157
A6111081
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP