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

July 11, 2018 updated by: L. Jay Katz MD, Wills Eye

Ocular Surface Changes With Topical Prostaglandin Analog Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

58

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • prostaglandin analog
Drug: Travatan Z
one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime
Other Names:
  • prostaglandin analog
Other: 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 Names:
  • prostaglandin analog
Drug: Travatan Z
one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime
Other Names:
  • prostaglandin analog

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1 month, 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tear Production
Time Frame: Baseline, 1 month, 2 months
Tear production, measured by Schirmer test in millimeters
Baseline, 1 month, 2 months
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).
Baseline, 1 month, 2 months
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.
Baseline, 1 month, 2 months
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.
Baseline, 1 month, 2 months
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).
Baseline, 1 month, 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wills Eye

Collaborators

Pfizer

Investigators

  • Principal Investigator: Leslie J Katz, MD, Wills Eye Glaucoma Service

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

November 25, 2008

First Submitted That Met QC Criteria

November 25, 2008

First Posted (Estimate)

November 26, 2008

Study Record Updates

Last Update Posted (Actual)

July 12, 2018

Last Update Submitted That Met QC Criteria

July 11, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-875

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

A manuscript has been published.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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