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

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

Study Overview

• Status: Unknown
• Conditions: Dry Eye
• Intervention / Treatment: Drug: FreshKote; Drug: Systane

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Lake Villa, Illinois, United States
      • Recruiting
      • Jackson Eye, S.C
  • Missouri
    • Chesterfield, Missouri, United States
      • Recruiting
      • Pepose Vision Institute
      • Principal Investigator: Jay Pepose, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Innovative Medical
• Investigators: Principal Investigator: Jay Pepose, MD, Pepose Vision Institute; Principal Investigator: Mitch Jackson, MD, Jackson Eye, S.C

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): November 1, 2012
• Study Completion (Anticipated): November 1, 2012

Study Registration Dates

• First Submitted: June 29, 2011
• First Submitted That Met QC Criteria: June 29, 2011
• First Posted (Estimate): June 30, 2011

Study Record Updates

• Last Update Posted (Estimate): June 14, 2012
• Last Update Submitted That Met QC Criteria: June 13, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: Focus2011-001