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

Dry Eye Disease Clinical Trial

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®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00799682
• Other study ID #: GA6111ZH
• Status: Completed
• Phase: Phase 4
• First received: November 26, 2008
• Last updated: July 20, 2011
• Start date: October 2008
• Est. completion date: February 2011

Study information

• Verified date: July 2011
• Source: Ophthalmic Consultants of Long Island
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dry Eye Disease
• Eye Diseases
• Glaucoma
• Hypertension
• Ocular Hypertension
• Signs and Symptoms

Intervention

Drug:
• Xalatan
0.005% 1 drop in each eye daily between 7:00 p.m. and 9:00 p.m.
• Travatan Z
0.004%, 1 drop in each eye daily between 7:00 p.m. and 9:00 p.m.

Locations

Country	Name	City	State
United States	Ophthalmic Consultants of Long Island	East Meadow	New York
United States	Ophthalmic Consultants of Long Island	Lynbrook	New York
United States	Ophthalmic Consultants of Long Island	Rockville Centre	New York
United States	Ophthalmic Consultants of Long Island	Stony Brook	New York
United States	Ophthalmic Consultants of Long Island	Valley Stream	New York

Sponsors (2)

Lead Sponsor	Collaborator
Ophthalmic Consultants of Long Island	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OSDI scores (patient's subjective assessment)		Eight Weeks	Yes
Secondary	Clinical Biomicroscopic changes as assessed by Masked Investigator		Eight Weeks	Yes