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

NCT00799682

Last updated date
Study Location
Ophthalmic Consultants of Long Island
East Meadow, New York, 11554, 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.
Dry Eye Disease
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

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


- 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.

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Dry Eye DiseaseExploratory Study Comparing Signs and Symptoms in Patients With Ocular Hypertension or Glaucoma Using Xalatan R® or Travatan Z®
NCT00799682
  1. East Meadow, New York
  2. Lynbrook, New York
  3. Rockville Centre, New York
  4. Stony Brook, New York
  5. Valley Stream, New York
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Exploratory Study Comparing Signs and Symptoms in Patients With Ocular Hypertension or Glaucoma Using Xalatan R® or Travatan Z®
Official Title  ICMJE 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®
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.
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: Supportive Care
Condition  ICMJE Dry Eye Disease
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Xalatan®
    Intervention: Drug: Xalatan
  • Active Comparator: Travatan Z®
    Intervention: Drug: Travatan Z
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: July 20, 2011)
56
Original Estimated Enrollment  ICMJE
 (submitted: November 28, 2008)
40
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT00799682
Other Study ID Numbers  ICMJE GA6111ZH
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marguerite McDonald, M.D., Ophthalmic Consultants of Long Island
Study Sponsor  ICMJE Ophthalmic Consultants of Long Island
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Marguerite McDonald, M.D.Ophthalmic Consultants of Long Island
Study Director:Barbara Burger, R.N.Ophthalmic Consultans of Long Island
PRS Account Ophthalmic Consultants of Long Island
Verification Date July 2011

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