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

Phase 4

• Conditions: Dry Eye
• Interventions: Drug: FreshKote; Drug: Systane

• Registration Number: NCT01386073
• Lead Sponsor: Innovative Medical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-29
• Study First Submitted QC: 2011-06-29
• Study First Posted: 2011-06-30
• Study Start: 2011-07
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-13
• Last Update Posted: 2012-06-14
• Primary Completion: 2012-11
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FreshKote	FreshKote	-
Systane	Systane	-

Primary Outcome Measures

Name	Time	Method
TBUT	Three months	Test that measures how long it takes for the tears to break up
Best Corrected Visual Acuity	Three months	Vision obtained with the best possible lens correction (glasses or contact lenses)

Trial Locations

Locations (2)

Jackson Eye, S.C; 🇺🇸 Lake Villa, Illinois, United States

Pepose Vision Institute; 🇺🇸 Chesterfield, Missouri, United States