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

Sponsor

Ophthalmic Consultants of Long Island (Other)

Overall Status

Completed

CT.gov ID

NCT00799682

Collaborator

Pfizer (Industry)

Enrollment

Locations

Arms

Duration (Months)

11.2

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Oct 1, 2008

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Feb 1, 2011

Arms and Interventions

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 Names: 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 Names: Topical Prostaglandin, Travaprost Ophthalmic Solution

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 Names:

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 Names:

Topical Prostaglandin, Travaprost Ophthalmic Solution

Outcome Measures

Primary Outcome Measures

OSDI scores (patient's subjective assessment) [Eight Weeks]

Secondary Outcome Measures

Clinical Biomicroscopic changes as assessed by Masked Investigator [Eight Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ophthalmic Consultants of Long Island	East Meadow	New York	United States	11554
2	Ophthalmic Consultants of Long Island	Lynbrook	New York	United States	11563
3	Ophthalmic Consultants of Long Island	Rockville Centre	New York	United States	11570
4	Ophthalmic Consultants of Long Island	Stony Brook	New York	United States	11790
5	Ophthalmic Consultants of Long Island	Valley Stream	New York	United States	11581

Sponsors and Collaborators

Ophthalmic Consultants of Long Island
Pfizer

Investigators

Principal Investigator: Marguerite McDonald, M.D., Ophthalmic Consultants of Long Island
Study Director: Barbara Burger, R.N., Ophthalmic Consultans of Long Island