Efficacy of FreshKote and Systane for the Treatment of Dry Eye and Improvement of Osmolarity

Status unconfirmed · Phase 4

Conditions studied: Dry Eye

In brief

The purpose of this study is to compare the efficacy of FreshKote and Systane for the reduction of dry eye signs and symptoms.

Key facts

Study ID

NCT01386073

Run by

Innovative Medical

People needed

40

Starts

2011-07-01

Expected to finish

2012-11-01

Last updated by the study team

2012-06-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Dry eye patients with Level 2 disease or greater as defined by the Delpi Panel
• 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

You may not qualify if…

• Presence of any active ocular disease other than dry eye
• 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

Where it is running

• Jackson Eye, S.C — Lake Villa, Illinois, United States (enrolling)
• Pepose Vision Institute — Chesterfield, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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