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®

Ophthalmic Consultants of Long Island1 site in 1 country56 target enrollmentOctober 2008

ConditionsDry Eye Disease

InterventionsXalatan Travatan Z

DrugsXalatan Travatan Z

Overview

Phase: Phase 4
Intervention: Xalatan
Conditions: Dry Eye Disease
Sponsor: Ophthalmic Consultants of Long Island
Enrollment: 56
Locations: 1
Primary Endpoint: OSDI scores (patient's subjective assessment)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2008

End Date

February 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ophthalmic Consultants of Long Island

Eligibility 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)

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