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

November 25, 2008
December 20, 2012
November 2008
January 2011   (final data collection date for primary outcome measure)
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.
Tear break up time (TBUT) [ Time Frame: monthly ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00798694 on ClinicalTrials.gov Archive Site
  • 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
Conjunctival hyperemia, ocular surface disease index questionnaire, subject preference, impression cytology, corneal and conjunctival staining, Schirmer test, visual acuity and intraocular pressure. [ Time Frame: monthly ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
How Similar Are Changes to the Surface of the Eye When Two Different Glaucoma Eye Drops Are Used?
Ocular Surface Changes With Topical Prostaglandin Analog Therapy

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Glaucoma
  • 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
  • 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.
    Interventions:
    • Drug: Xalatan
    • Drug: Travatan Z
  • 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.
    Interventions:
    • Drug: Xalatan
    • Drug: Travatan Z
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
February 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00798694
08-875
No
L. Jay Katz MD, Wills Eye
Wills Eye
Pfizer
Principal Investigator: L Jay Katz, MD Wills Eye Glaucoma Service
Wills Eye
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP