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

• Sponsor: Innovative Medical (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT01386073
• Collaborator: (none)
• Enrollment: 40
• Locations: 2
• Arms: 2
• Duration (Months): 16.1
• Patients Per Site: 20
• Patients Per Site Per Month: 1.2

Study Details

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
• Anticipated 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: Jul 1, 2011
• Anticipated Primary Completion Date: Nov 1, 2012
• Anticipated Study Completion Date: Nov 1, 2012

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 [Three months]

   Test that measures how long it takes for the tears to break up

2. Best Corrected Visual Acuity [Three months]

   Vision obtained with the best possible lens correction (glasses or contact lenses)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Jackson Eye, S.C	Lake Villa	Illinois	United States
2	Pepose Vision Institute	Chesterfield	Missouri	United States

Sponsors and Collaborators

• Innovative Medical

Investigators

• Principal Investigator: Jay Pepose, MD, Pepose Vision Institute
• Principal Investigator: Mitch Jackson, MD, Jackson Eye, S.C

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01386073
• Other Study ID Numbers: Focus2011-001
• First Posted: Jun 30, 2011
• Last Update Posted: Jun 14, 2012
• Last Verified: Jun 1, 2012

• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca

Study Results

No Results Posted as of Jun 14, 2012