Status:
COMPLETED
Dry Eye and Irritation Comparison of Latanoprost With the Preservative Versus Travoprost Without Preservative
Lead Sponsor:
United States Air Force
Collaborating Sponsors:
Alcon Research
Conditions:
Ocular Dryness
Ocular Irritation
Eligibility:
All Genders
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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00803387
Start Date
April 1 2008
End Date
September 1 2008
Last Update
December 5 2008
Active Locations (1)
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1
WHMC
Lackland Air Force Base, Texas, United States, 78236