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

NCT ID: NCT00803387

Last Updated: 2008-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ocular Dryness Ocular Irritation Open-Angle Glaucoma Ocular Hypertension

Keywords

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ocular dryness ocular irritation open-angle glaucoma ocular hypertension TravatanZ Xalatan

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

Travaprost without BAC (Travatan Z)

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role collaborator

United States Air Force

FED

Sponsor Role lead

Responsible Party

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USAF

Principal Investigators

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James R Townley, MD

Role: PRINCIPAL_INVESTIGATOR

United States Air Force

Locations

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WHMC

Lackland Air Force Base, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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FWH20080020H

Identifier Type: -

Identifier Source: org_study_id