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

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01386073
• Other study ID #: Focus2011-001
• Status: Recruiting
• Phase: Phase 4
• First received: June 29, 2011
• Last updated: June 13, 2012
• Start date: July 2011
• Est. completion date: November 2012

Study information

• Verified date: June 2012
• Source: Innovative Medical
• Contact: Jenna Piel
• Phone: 951-653-5566
• Email: j.piel[@]imedsonline.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• FreshKote
Three times a day for three months
• Systane
three times a day for three months

Locations

Country	Name	City	State
United States	Pepose Vision Institute	Chesterfield	Missouri
United States	Jackson Eye, S.C	Lake Villa	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Innovative Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TBUT	Test that measures how long it takes for the tears to break up	Three months	No
Primary	Best Corrected Visual Acuity	Vision obtained with the best possible lens correction (glasses or contact lenses)	Three months	No