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

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ClinicalTrials.gov Identifier: NCT00803387
Recruitment Status : Completed
First Posted : December 5, 2008
Last Update Posted : December 5, 2008
Sponsor:
Collaborator:
Alcon Research
Information provided by:
United States Air Force

Brief Summary:
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.

Condition or disease Intervention/treatment
Ocular Dryness Ocular Irritation Open-Angle Glaucoma Ocular Hypertension Drug: Travaprost without BAC (Travatan Z)

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Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dry Eye and Irritation Comparison of Latanoprost 0.005% With the Preservative Benzalkonium Chloride (BAC) Vs Travoprost 0.004% Without BAC
Study Start Date : April 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008


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.




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

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): NCT00803387


Locations
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United States, Texas
WHMC
Lackland AFB, Texas, United States, 78236
Sponsors and Collaborators
United States Air Force
Alcon Research
Investigators
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Principal Investigator: James R Townley, MD United States Air Force

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Responsible Party: Capt James Richard Townley, MD, USAF
ClinicalTrials.gov Identifier: NCT00803387     History of Changes
Other Study ID Numbers: FWH20080020H
First Posted: December 5, 2008    Key Record Dates
Last Update Posted: December 5, 2008
Last Verified: December 2008

Keywords provided by United States Air Force:
ocular dryness
ocular irritation
open-angle glaucoma
ocular hypertension
TravatanZ
Xalatan

Additional relevant MeSH terms:
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Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Latanoprost
Travoprost
Antihypertensive Agents