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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
L. Jay Katz MD, Wills Eye
ClinicalTrials.gov Identifier:
NCT00798694
First received: November 25, 2008
Last updated: December 20, 2012
Last verified: December 2012
History of Changes
  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 4

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:

MedlinePlus related topics: Glaucoma
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 ]
    Measurement made in seconds using a timer. Average of 3 measurements taken.


Secondary Outcome Measures:
  • Conjunctival hyperemia [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Redness grading of the conjunctiva on a scale from 0 to 3 (none, mild, moderate and severe).

  • 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, Principal Investigator, Wills Eye
ClinicalTrials.gov Identifier: NCT00798694     History of Changes
Other Study ID Numbers: 08-875
Study First Received: November 25, 2008
Last Updated: December 20, 2012
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 May 16, 2013