Dry Eye and Irritation Comparison of Latanoprost With the Preservative Versus Travoprost Without Preservative

December 4, 2008 updated by: United States Air Force

Dry Eye and Irritation Comparison of Latanoprost 0.005% With the Preservative Benzalkonium Chloride (BAC) Vs Travoprost 0.004% Without BAC

Although Benzalkonium chloride (BAC) has been used as a preservative for many years, many studies have demonstrated that prolonged use of topical ocular medications preserved with BAC may exacerbate sequelae associated with ocular surface disease. These effects could lead to the induction of subclinical inflammation,1 reduction of corneal epithelial barrier function, 2, 3 destabilization of the tear film, 4 cataract formation, 5 and an overall higher incidence of patient complaints of dryness and irritation. 4-6 This study will compare the efficacy of travoprost 0.004% without benzalkonium chloride (BAC) to that of the marketed formulation of latanoprost 0.005%with BAC in patients with dryness and irritation and open-angle glaucoma or ocular hypertension. A double blind comparison will be used to assess whether those two different formulations will affect the tear breakup times, corneal staining, and baseline tear secretion tests in patients that are already taking latanoprost regularly with complaints of dryness and irritation. Patients included in the study will be given two bottles, one labeled for their right eye and the other for their left eye. Each pair of bottles will be identical in appearance and randomized with either latanoprost or travoprost and each pair will be assigned a number to aid in future analysis of the final results.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

33

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
    • Texas
      • Lackland AFB, Texas, United States, 78236
        • WHMC

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Must be eligible for care at WHMC ie active duty, military retirees and their dependents

  • patient must already be using xalatan for at least 1 month prior to study enrollment in both eyes and have complaints of dry eye and/or irritation.
  • any race and of either sex, diagnosed with open angle glaucoma (OAG) (with or without pseudoexfoliation or pigment dispersion components) or ocular hypertension (OHT)
  • tear break up times (TBUT) < 6 seconds on xalatan monotherapy.

Description

Inclusion Criteria:

  • patient must already be using xalatan for at least 1 month prior to study enrollment in both eyes and have complaints of dry eye and/or irritation.
  • study population:
  • any race and of either sex, diagnosed with open angle glaucoma (OAG) (with or without pseudoexfoliation or pigment dispersion components) or ocular hypertension (OHT)
  • tear break up times (TBUT) < 6 seconds on xalatan monotherapy.

Exclusion Criteria:

  • unequal baseline measurements (i.e. difference in cup to disc ratio of .1 or greater, intraocular pressure difference of 2 or more mm Hg),
  • difference in subjective symptoms of dryness/irritation between the patient's two eyes;
  • history of ocular trauma or intraocular surgery within the past 6 months in either eye;
  • ocular infection, ocular inflammation, or ocular laser surgery within the past 3 months in either eye;
  • severe hypersensitivity to study medications or vehicle;
  • any abnormality preventing reliable applanation tonometry;
  • anterior chamber angle less than 10 degrees in either eye,
  • severe central visual field loss in either eye;
  • cup-to-disc ratio greater than 0.80 in either eye;
  • contraindications to pupil dilation; previous diagnosis of autoimmune diseases;
  • chronic glucocorticoid use within 1 month of and during the eligibility phase or intermittent glucocorticoid use within 2 weeks of the eligibility phase;
  • any type of glaucoma other than OAG or OHT;
  • therapy with another investigational agent within 30 days of study start;
  • use of any other topical or systemic ocular hypotensive medication during the study.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients taking Xalatan with ocular dryness or irritation
  • patient must already be using xalatan for at least 1 month prior to study enrollment in both eyes and have complaints of dry eye and/or irritation.
  • any race and of either sex, diagnosed with open angle glaucoma (OAG) (with or without pseudoexfoliation or pigment dispersion components) or ocular hypertension (OHT)
Drug: Travaprost without BAC (Travatan Z)
A double blind comparison was used to assess whether Xalatan or TrvatanZ affects the tear breakup times, corneal staining, and baseline tear secretion tests in patients that are already taking latanoprost regularly with complaints of dryness and irritation. Patients included in the study will be given two bottles, one labeled for their right eye and the other for their left eye. Each pair of bottles will be identical in appearance and randomized with either latanoprost or travoprost and each pair will be assigned a number to aid in future analysis of the final results. One Drop from both bottles will be dispensed in the respective eye once a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Routine eye exams in addition to Ocular Surface Disease Index (OSDI) surveys at the beginning and end of the study. Patients will also be asked to rate their extent of dryness and irritation of either eye on a scale of 1-10 at each visit.
Time Frame: Each patient will be followed every 3-4 weeks for 3 months
Each patient will be followed every 3-4 weeks for 3 months

Collaborators and Investigators

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

Sponsor

United States Air Force

Collaborators

Alcon Research

Investigators

  • Principal Investigator: James R Townley, MD, United States Air Force

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

April 1, 2008

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

December 4, 2008

First Submitted That Met QC Criteria

December 4, 2008

First Posted (Estimate)

December 5, 2008

Study Record Updates

Last Update Posted (Estimate)

December 5, 2008

Last Update Submitted That Met QC Criteria

December 4, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FWH20080020H

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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