Efficacy of FreshKote and Systane for the Treatment of Dry Eye and Improvement of Osmolarity
1 other identifier
interventional
40
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2011
CompletedFirst Posted
Study publicly available on registry
June 30, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedJune 14, 2012
June 1, 2012
1.3 years
June 29, 2011
June 13, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
TBUT
Test that measures how long it takes for the tears to break up
Three months
Best Corrected Visual Acuity
Vision obtained with the best possible lens correction (glasses or contact lenses)
Three months
Study Arms (2)
FreshKote
ACTIVE COMPARATORSystane
PLACEBO COMPARATORInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Jackson Eye, S.C
Lake Villa, Illinois, United States
Pepose Vision Institute
Chesterfield, Missouri, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jay Pepose, MD
Pepose Vision Institute
- PRINCIPAL INVESTIGATOR
Mitch Jackson, MD
Jackson Eye, S.C
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 29, 2011
First Posted
June 30, 2011
Study Start
July 1, 2011
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
June 14, 2012
Record last verified: 2012-06