How Similar Are Changes to the Surface of the Eye When Two Different Glaucoma Eye Drops Are Used? - Full Text View

Sponsor:	Wills Eye
Collaborator:	Pfizer
Information provided by:	Wills Eye
ClinicalTrials.gov Identifier:	NCT00798694

Purpose

The purpose of this research study is to determine whether one glaucoma eye drop is less likely to cause changes to the surface of the eye (conjunctiva) than another. The investigators plan to determine this theory by comparing the results when a patient is using two different prostaglandins, Xalatan and Travatan Z. (Both of these drops are presently on the market and are approved by the FDA for the treatment of eye pressure). Because this study will be masked, the clinician who reviews the study results will not know what study drop each patient has been using.

Condition	Intervention	Phase
Glaucoma	Drug: Xalatan Drug: Travatan Z	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Ocular Surface Changes With Topical Prostaglandin Analog Therapy

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Latanoprost Travoprost

U.S. FDA Resources

Further study details as provided by Wills Eye:

Primary Outcome Measures:

Tear break up time (TBUT) [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Conjunctival hyperemia [ Time Frame: 2 months ] [ Designated as safety issue: No ]
ocular surface disease index questionnaire [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Patient answers 12 questions regarding eye comfort under different conditions/environments.
impression cytology [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Looking for inflammatory cells in 4 quadrants on the conjunctiva
staining [ Time Frame: 2 months ] [ Designated as safety issue: No ]
corneal staining with fluorescein and conjunctival staining with lissamine green

Enrollment:	58
Study Start Date:	November 2008
Study Completion Date:	February 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
New to Meds Naive to glaucoma therapy medical or surgical. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.	Drug: Xalatan one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime Other Name: prostaglandin analog Drug: Travatan Z one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime Other Name: prostaglandin analog
Currently on Xalatan Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.	Drug: Xalatan one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime Other Name: prostaglandin analog Drug: Travatan Z one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime Other Name: prostaglandin analog

Detailed Description:

Two groups will be entered into this study: group 1 will be naive to treatment and group 2 will be using Xalatan for at least one month. Both groups will be using one drop at bedtime of Xalatan in the right eye and one drop at bedtime of Travatan Z in the left eye.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 21 or older
Able to understand protocol and agree to 3 visits
Any type of glaucoma
SLT, ALT, PI accepted
Naïve: No prior glaucoma treatment (medical or surgical)
If pt non-compliant, must be off meds 3 months
Xalatan: At least one month use

Exclusion Criteria:

Both Groups: Any history of ocular surface disease
Dry eye syndrome or prior Restasis use
Prior ocular surgery other than cataract extractions
Uveitis or other inflammatory disease of the eye or adnexa
Systemic medications that might influence ocular inflammation
Any active inflammation or infection
Pregnancy or intention to become pregnant
Naïve: Prior use of topical glaucoma med unless off for 3 months.
Use of preserved artificial tear preparations in last 30 days and more than one year history of chronic use
Xalatan: Prior use of Travatan or Travatan Z

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798694

Locations

United States, Pennsylvania
Wills Eye Glaucoma Service
Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Wills Eye

Pfizer

Investigators

Principal Investigator:

L Jay Katz, MD

Wills Eye Glaucoma Service

More Information

No publications provided

Responsible Party:	L. Jay Katz, MD, Wills Eye Institute
ClinicalTrials.gov Identifier:	NCT00798694 History of Changes
Other Study ID Numbers:	08-875
Study First Received:	November 25, 2008
Last Updated:	February 23, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Wills Eye:

glaucoma
impression cytology
ocular surface changes
prostaglandins

Additional relevant MeSH terms:

Glaucoma
Ocular Hypertension
Eye Diseases
Latanoprost
Travoprost

Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012