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

Innovative Medical

Status and phase: Unknown; Phase 4

Conditions: Dry Eye

Treatments: Drug: FreshKote; Drug: Systane

Study type: Interventional

Funder types: Industry

Identifiers

NCT01386073

Focus2011-001

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

FreshKote

Active Comparator group

Treatment:

Drug: FreshKote

Systane

Placebo Comparator group

Treatment:

Drug: Systane