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Trial record 1 of 1 for:    NCT00798694
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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
Results First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
L. Jay Katz MD, Wills Eye

Tracking Information
First Submitted Date  ICMJE November 25, 2008
First Posted Date  ICMJE November 26, 2008
Results First Submitted Date  ICMJE January 7, 2016
Results First Posted Date  ICMJE July 12, 2018
Last Update Posted Date July 12, 2018
Study Start Date  ICMJE November 2008
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
Change in Tear Break up Time (TBUT) [ Time Frame: Baseline, 1 month, 2 months ]
Difference of tear break up time (in seconds, average of 3 measurements) at one and two months after enrollment.
Original Primary Outcome Measures  ICMJE
 (submitted: November 25, 2008)
Tear break up time (TBUT) [ Time Frame: monthly ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
  • Tear Production [ Time Frame: Baseline, 1 month, 2 months ]
    Tear production, measured by Schirmer test in millimeters
  • Conjunctival Hyperemia Score [ Time Frame: Baseline, 1 month, 2 months ]
    Conjunctival hyperemia is the amount of redness on the white part of the eye. A total score was obtained by the sum of assessments in 6 areas of each eye are which are scored from 0 to 3 (0 = no redness; 3 = severe redness), then summed per eye for a total score range of 0-18 (0 = no redness; 18 = severe redness).
  • Intraocular Pressure [ Time Frame: Baseline, 1 month, 2 months ]
    Intraocular pressure (the fluid pressure inside the eye) was measured two times in each eye using the Goldman applanation tonometer and averaged.
  • Ocular Surface Disease Index Score [ Time Frame: Baseline, 1 month, 2 months ]
    Ocular Surface Disease Index Scores (OSDI) were obtained from a 12-item validated OSDI questionnaire completed by each participant. This is an assessment related to eye comfort. Each question's score ranges from 0 = no disability to 4 = greatest disability. The total score is multiplied by 25 then divided by the number of questions answered then matched to a grid ranging from 0 to 100 with 0 having symptoms reported none of the time versus 100 having disability symptoms reported all of the time.
  • Corneal Staining Score [ Time Frame: Baseline, 1 month, 2 months ]
    Corneal staining is an indication of the amount of dryness of the cornea (front clear part of the eye). A total score was obtained by the sum of assessments in five areas of each eye which are scored from 0 to 3 (0 = no dryness; 3 = severe dryness), then summed per eye for a total score range of 0-15 (0 = no dryness; 15 = severe dryness).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE How Similar Are Changes to the Surface of the Eye When Two Different Glaucoma Eye Drops Are Used?
Official Title  ICMJE Ocular Surface Changes With Topical Prostaglandin Analog Therapy
Brief Summary To determine whether one glaucoma eye drop is less likely to cause changes to the surface of the eye (conjunctiva) than another. The two different prostaglandins are Xalatan and Travatan Z.
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 before enrollment. 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. Both of these drops are presently on the market and approved by the FDA for treatment of lowering eye pressure. Because this study will be masked, the examining clinician will not know what study drop each patient has been using.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description:
Doctors assessing patients were masked to treatment. Patients used open label Xalantan in the right eye and Travatan Z in the left eye.
Primary Purpose: Treatment
Condition  ICMJE Glaucoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2011)
58
Original Estimated Enrollment  ICMJE
 (submitted: November 25, 2008)
80
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 21 or older
  • Able to understand protocol and agree to 3 visits
  • Any type of glaucoma
  • Selective laser trabeculoplasty, Argon laser trabeculoplasty, peripheral iridotomy accepted
  • Naïve: No prior glaucoma treatment (medical or surgical)
  • If patient 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 medication 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00798694
Other Study ID Numbers  ICMJE 08-875
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: A manuscript has been published.
Responsible Party L. Jay Katz MD, Wills Eye
Study Sponsor  ICMJE Wills Eye
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Leslie J Katz, MD Wills Eye Glaucoma Service
PRS Account Wills Eye
Verification Date July 2018

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