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

NCT00799682 | Completed Phase 4

• 1 other identifier: GA6111ZH
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 5

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.

Conditions

Dry Eye Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• OSDI scores (patient's subjective assessment)

  Eight Weeks

Secondary Outcomes (1)

• Clinical Biomicroscopic changes as assessed by Masked Investigator

  Eight Weeks

Study Arms (2)

Xalatan®

ACTIVE COMPARATOR

Drug: Xalatan

Travatan Z®

ACTIVE COMPARATOR

Drug: Travatan Z

Interventions

Xalatan DRUG

0.005% 1 drop in each eye daily between 7:00 p.m. and 9:00 p.m.

Also known as: Topical Prostaglandin, Latanoprost Ophthalmic Solution

Xalatan®

Travatan Z DRUG

0.004%, 1 drop in each eye daily between 7:00 p.m. and 9:00 p.m.

Also known as: Topical Prostaglandin, Travaprost Ophthalmic Solution

Travatan Z®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ophthalmic Consultants of Long Island: lead
• Pfizer: collaborator

Study Sites (5)

Ophthalmic Consultants of Long Island

East Meadow, New York, 11554, United States

Location

Ophthalmic Consultants of Long Island

Lynbrook, New York, 11563, United States

Location

Ophthalmic Consultants of Long Island

Rockville Centre, New York, 11570, United States

Location

Ophthalmic Consultants of Long Island

Stony Brook, New York, 11790, United States

Location

Ophthalmic Consultants of Long Island

Valley Stream, New York, 11581, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle; Hyperemia

Interventions

Latanoprost; Prostaglandins; Travoprost

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Cloprostenol

Study Officials

• Marguerite McDonald, M.D.

  Ophthalmic Consultants of Long Island

  PRINCIPAL INVESTIGATOR

• Barbara Burger, R.N.

  Ophthalmic Consultans of Long Island

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 26, 2008
• First Posted: December 1, 2008
• Study Start: October 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2011
• Last Updated: July 21, 2011

Record last verified: 2011-07

Locations

US (5)