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Exploratory Study Comparing Signs and Symptoms in Patients With Ocular Hypertension or Glaucoma Using Xalatan R® or Travatan Z®

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00799682
Recruitment Status : Completed
First Posted : December 1, 2008
Last Update Posted : July 21, 2011
Sponsor:
Collaborator:
Pfizer
Information provided by:
Ophthalmic Consultants of Long Island

Brief Summary:
The purpose of this study is to determine if there is a difference in the ocular signs and symptoms of subjects' eyes using Xalatan® 0.005% versus Travatan Z® 0.004% based on the outcome of subject assessment and clinical assessment in patients with Ocular Hypertension or Glaucoma with mild to moderate dry eye at baseline in accordance with the Oxford Grading Scale.

Condition or disease Intervention/treatment Phase
Dry Eye Disease Drug: Xalatan Drug: Travatan Z Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: An 8 Week, Single Masked, Parallel-Group, Exploratory Study Comparing Ocular Surface Signs and Symptoms in Monotherapy Ocular Hypertension or Glaucoma Patients Randomized to Either Xalatan® or Travatan Z®
Study Start Date : October 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Travoprost

Arm Intervention/treatment
Active Comparator: Xalatan® Drug: Xalatan
0.005% 1 drop in each eye daily between 7:00 p.m. and 9:00 p.m.
Other Name: Topical Prostaglandin, Latanoprost Ophthalmic Solution

Active Comparator: Travatan Z® Drug: Travatan Z
0.004%, 1 drop in each eye daily between 7:00 p.m. and 9:00 p.m.
Other Name: Topical Prostaglandin, Travaprost Ophthalmic Solution




Primary Outcome Measures :
  1. OSDI scores (patient's subjective assessment) [ Time Frame: Eight Weeks ]

Secondary Outcome Measures :
  1. Clinical Biomicroscopic changes as assessed by Masked Investigator [ Time Frame: Eight Weeks ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or Female 18 years of age or older
  • Only patients who satisfy all informed consent requirements may be included in the study
  • Be likely to complete the entire course of study and comply with study drop regimen, guidelines and visits
  • Able to understand drop instructions and instill study drops
  • Patients must be on monotherapy for Ocular Hypertension or Glaucoma and agree to a washout period, as according to Appendix E
  • Patient has Ocular Hypertension, chronic Open-Angle Glaucoma, chronic Angle-Closure Glaucoma with patent iridotomy/iridectomy, Pseudo Exfoliate Glaucoma, or Pigmentary Glaucoma in each eye at screening visit.
  • Patients using systemic non-glaucoma medications known to lower IOP may be included, if on stable dose >30 days prior to screening visit and agree to maintain the regimen throughout the course of the study.
  • Patients using non-prescription eye drops or prescription topical eye drops for dry eye may be included, if on stable dose 30 days prior to screening visit and agree to maintain the regimen throughout the course of the study.
  • Patients who wear contact lenses with a maintained wearing pattern for the duration of the study
  • Best Corrected LogMar VA of ≤0.70 =(20/100 Snellen equivalent)
  • Hyperemia Grading ≤2
  • IOP ≤ 30 mmHg
  • Shirmers 3mm - 9.75mm
  • Tear break-up time (TBUT) 4 seconds - 9seconds
  • Must meet the Biomicroscopic Criteria for both eyes as defined by the Oxford Grading Scale
  • Generally good and stable overall health

Exclusion Criteria:

  • Females of childbearing potential (those who are not surgically sterilized or defined as one-year post-menopausal) are excluded from participation in the study if they meet any one of the following conditions:They are currently pregnant,They have a positive result on the urine pregnancy test at the Screening Visit,They intend to become pregnant during the study period,They are breast-feeding,or They are not using highly effective birth control measures:
  • Hormonal-oral, implanted, transdermal or injected contraceptives;
  • Mechanical-spermicide in conjunction with a barrier such as a condom or diaphragm or IUD Note: All females of childbearing potential must consent to a urine pregnancy test at Screening. Females of childbearing potential are to be instructed to inform the investigator if they become pregnant during the study. Should this occur, the Investigator shall immediately contact the Sponsor. For non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, if the patient becomes sexually active during the study, she must agree to use adequate birth control methods as defined above for the remainder of the study.
  • Patients who are currently on an investigational agent or discontinued within 30 days prior to the Screening Visit
  • Uncontrolled systemic disease
  • Patients who have a known medical history of allergy or sensitivity to prostaglandin drugs (topical and/or systemic)
  • Patient with any history of refractive surgery
  • History of ocular trauma within the past six months in either eye
  • History of ocular infection or ocular inflammation within the past three months in either eye
  • History of clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in either eye based on the assessment of the Investigator
  • History of any severe ocular pathology according to the Oxford Grading Scale
  • greater than Grade 4 dry eye) in either eye
  • Intraocular surgery within the past six months as determined by patient history and/or examination in either eye.
  • Ocular laser surgery or Punctal Cautery within the past three months as determined by patient history and/or examination in either eye
  • Punctal Plugs insertion ≤ 7 days prior to (Visit 1) Screening
  • Any abnormality preventing reliable applanation tonometry of either eye.
  • Contraindication to pupil dilation or patients with cycloplegia
  • Patients with best-corrected visual acuity score worse than 0.70 LogMar (20/100) score in either eye
  • Patients with ≤30 days stable dosing regimen before the Screening Visit of any medications or substances administered by any route and used on a chronic basis
  • History of Stevens-Johnson Syndrome or Ocular Pemphigoid
  • History of liver disease
  • Severe clinical vitamin deficiencies or history of vitamin overdose
  • Highly variable self-administration of over-the-counter vitamin/herbal products
  • Any steroid use within the past 30 days
  • Corneal pathology, which could, and of itself, cause an ocular surface disorder
  • Visual Field loss which in the opinion of the Investigator is functionally significant or evidence of progress visual field loss within the last year prior to the (Visit 2) Baseline/Randomization
  • Patient has a condition or is in a situation which, in the investigator's opinion, may put the subject at a significant risk, may confound study results, or may interfere significantly with the subject's participation in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00799682


Locations
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United States, New York
Ophthalmic Consultants of Long Island
East Meadow, New York, United States, 11554
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States, 11563
Ophthalmic Consultants of Long Island
Rockville Centre, New York, United States, 11570
Ophthalmic Consultants of Long Island
Stony Brook, New York, United States, 11790
Ophthalmic Consultants of Long Island
Valley Stream, New York, United States, 11581
Sponsors and Collaborators
Ophthalmic Consultants of Long Island
Pfizer
Investigators
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Principal Investigator: Marguerite McDonald, M.D. Ophthalmic Consultants of Long Island
Study Director: Barbara Burger, R.N. Ophthalmic Consultans of Long Island
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Responsible Party: Marguerite McDonald, M.D., Ophthalmic Consultants of Long Island
ClinicalTrials.gov Identifier: NCT00799682    
Other Study ID Numbers: GA6111ZH
First Posted: December 1, 2008    Key Record Dates
Last Update Posted: July 21, 2011
Last Verified: July 2011
Keywords provided by Ophthalmic Consultants of Long Island:
Dry Eye
Monotherapy for Ocular Hypertension, Glaucoma
Ocular Hypertension
Chronic Open-Angle Glaucoma
Chronic Angle-Closure Glaucoma
Iridotomy
Iridectomy
Pseudo Exfoliate
Pigmentary Glaucoma
Systemic Non-Glaucoma Medications
Hyperemia
Additional relevant MeSH terms:
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Glaucoma
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Ocular Hypertension
Eye Diseases
Hypertension
Vascular Diseases
Cardiovascular Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Latanoprost
Travoprost
Pharmaceutical Solutions
Ophthalmic Solutions
Antihypertensive Agents