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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01386073
Recruitment Status : Unknown
Verified June 2012 by Innovative Medical.
Recruitment status was:  Recruiting
First Posted : June 30, 2011
Last Update Posted : June 14, 2012
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Dry Eye Drug: FreshKote Drug: Systane Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of FreshKote and Systane for the Treatment of Dry Eye and Improvement of Osmolarity
Study Start Date : July 2011
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
Drug Information available for: Systane
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: FreshKote Drug: FreshKote
Three times a day for three months
Placebo Comparator: Systane Drug: Systane
three times a day for three months


Outcome Measures

Primary Outcome Measures :
  1. TBUT [ Time Frame: Three months ]
    Test that measures how long it takes for the tears to break up

  2. Best Corrected Visual Acuity [ Time Frame: Three months ]
    Vision obtained with the best possible lens correction (glasses or contact lenses)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01386073


Contacts
Contact: Jenna Piel 951-653-5566 j.piel@imedsonline.com

Locations
United States, Illinois
Jackson Eye, S.C Recruiting
Lake Villa, Illinois, United States
Contact: Jenna Piel    951-653-5566    j.piel@imedsonline.com   
Principal Investigator: Mitch Jackson, MD         
United States, Missouri
Pepose Vision Institute Recruiting
Chesterfield, Missouri, United States
Contact: Jenna Piel    951-653-5566    j.piel@imedsonline.com   
Principal Investigator: Jay Pepose, MD         
Sponsors and Collaborators
Innovative Medical
Investigators
Principal Investigator: Jay Pepose, MD Pepose Vision Institute
Principal Investigator: Mitch Jackson, MD Jackson Eye, S.C
More Information

Responsible Party: Melissa Earl, CRO
ClinicalTrials.gov Identifier: NCT01386073     History of Changes
Other Study ID Numbers: Focus2011-001
First Posted: June 30, 2011    Key Record Dates
Last Update Posted: June 14, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Povidone
Plasma Substitutes
Blood Substitutes