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

• Status: Unknown status
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Innovative Medical
• Treatments: Povidone

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