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

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ClinicalTrials.gov Identifier: NCT00798694
Recruitment Status : Completed
First Posted : November 26, 2008
Last Update Posted : December 21, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
L. Jay Katz MD, Wills Eye

Brief Summary:
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 or disease Intervention/treatment Phase
Glaucoma Drug: Xalatan Drug: Travatan Z Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ocular Surface Changes With Topical Prostaglandin Analog Therapy
Study Start Date : November 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Travoprost

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Tear break up time (TBUT) [ Time Frame: 2 months ]
    Measurement made in seconds using a timer. Average of 3 measurements taken.


Secondary Outcome Measures :
  1. Conjunctival hyperemia [ Time Frame: 2 months ]
    Redness grading of the conjunctiva on a scale from 0 to 3 (none, mild, moderate and severe).

  2. ocular surface disease index questionnaire [ Time Frame: 2 months ]
    Patient answers 12 questions regarding eye comfort under different conditions/environments.

  3. impression cytology [ Time Frame: 2 months ]
    Looking for inflammatory cells in 4 quadrants on the conjunctiva

  4. staining [ Time Frame: 2 months ]
    corneal staining with fluorescein and conjunctival staining with lissamine green



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Gupta SR, Ichhpujani P, Wizov SS, Wittpenn JR, Moster MR, Pro MJ, Rapuano CJ, Cruz-Colon C, Myers JS, Katz LJ. Effects of Latanoprost Versus Travoprost with Sofzia on Ocular Surface. ARVO E-abstract 168/A391 2010

Responsible Party: L. Jay Katz MD, Principal Investigator, Wills Eye
ClinicalTrials.gov Identifier: NCT00798694     History of Changes
Other Study ID Numbers: 08-875
First Posted: November 26, 2008    Key Record Dates
Last Update Posted: December 21, 2012
Last Verified: December 2012

Keywords provided by L. Jay Katz MD, Wills Eye:
glaucoma
impression cytology
ocular surface changes
prostaglandins

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Ophthalmic Solutions
Latanoprost
Travoprost
Pharmaceutical Solutions
Antihypertensive Agents