Efficacy of FreshKote and Systane for the Treatment of Dry Eye and Improvement of Osmolarity
NCT ID: NCT01386073
Last Updated: 2012-06-14
Study Results
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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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2011-07-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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FreshKote
FreshKote
Three times a day for three months
Systane
Systane
three times a day for three months
Interventions
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FreshKote
Three times a day for three months
Systane
three times a day for three months
Eligibility Criteria
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Inclusion Criteria
* Tear osmolarity of at least 308 mosm
* At least 18 years of age, Male or Female
* Willing to provide written informed consent
* Likely to complete all study visits
* If currently using ocular lubricants, must complete a 10-14 day washout
Exclusion Criteria
* Use of topical ophthalmic medications
* Use of contact lenses during the trial
* Pregnant or nursing, or planning a pregnancy. Patients will be asked if they are pregnant or may be pregnant and excluded if they answer in the affirmative.
* Any known sensitivity to any ingredients of either study drop
* Oral anti-inflammatory medications, omega 3 supplements, or doxycycline
* Punctal plugs inserted within the last 6 months or less
* Uncontrolled systemic disease
* Subjects with known sensitivity or inappropriate responsiveness to any of the medications used.
* Acute or chronic disease or illness that would increase risk or confound study results (e.g., uncontrolled diabetes mellitus, immunocompromised, etc.)
* Corneal abnormalities (e.g., ecstatic diseases, degenerations, or corneal dystrophies of the stroma or endothelium)
* Concurrent participation or participation in the last 30 days in any other clinical trial
18 Years
ALL
Yes
Sponsors
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Innovative Medical
INDUSTRY
Responsible Party
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CRO
Principal Investigators
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Jay Pepose, MD
Role: PRINCIPAL_INVESTIGATOR
Pepose Vision Institute
Mitch Jackson, MD
Role: PRINCIPAL_INVESTIGATOR
Jackson Eye, S.C
Locations
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Jackson Eye, S.C
Lake Villa, Illinois, United States
Pepose Vision Institute
Chesterfield, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Focus2011-001
Identifier Type: -
Identifier Source: org_study_id
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