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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Innovative Medical.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT01386073
First received: June 29, 2011
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Dry Eye
Drug: FreshKote
Drug: Systane
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of FreshKote and Systane for the Treatment of Dry Eye and Improvement of Osmolarity

Resource links provided by NLM:


Further study details as provided by Innovative Medical:

Primary Outcome Measures:
  • TBUT [ Time Frame: Three months ] [ Designated as safety issue: No ]
    Test that measures how long it takes for the tears to break up

  • Best Corrected Visual Acuity [ Time Frame: Three months ] [ Designated as safety issue: No ]
    Vision obtained with the best possible lens correction (glasses or contact lenses)


Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: FreshKote Drug: FreshKote
Three times a day for three months
Placebo Comparator: Systane Drug: Systane
three times a day for three months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Melissa Earl, CRO
ClinicalTrials.gov Identifier: NCT01386073     History of Changes
Other Study ID Numbers: Focus2011-001
Study First Received: June 29, 2011
Last Updated: June 13, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014