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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01386073

Enrollment

Registered

2011-06-30

Start date

2011-07-31

Completion date

2012-11-30

Last updated

2012-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye

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.

Interventions

DRUGFreshKote

Three times a day for three months

DRUGSystane

three times a day for three months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
TBUT	Three months	Test that measures how long it takes for the tears to break up
Best Corrected Visual Acuity	Three months	Vision obtained with the best possible lens correction (glasses or contact lenses)

Countries

United States

Contacts

Primary ContactJenna Piel

j.piel@imedsonline.com951-653-5566

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026