Recruiting

FreshKote & Systane

Sponsor:

Innovative Medical

Code:

NCT01386073

Conditions

Dry Eye

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

FreshKote

Systane

Study Details

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.

Conditions

Dry Eye

Study ID

NCT01386073

Start date

Jul, 2011

Status verified date

Jun, 2012

Completion date

Nov, 2012

Anticipated

Primary completion date

Nov, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: FreshKote

placebo comparator: Systane

Interventions

FreshKote

Three times a day for three months

Systane

three times a day for three months

Primary outcome measure

  • TBUT [ Time Frame: Three months ]
  • Best Corrected Visual Acuity [ Time Frame: Three months ]

Central Contacts and Locations

Central contacts

Jenna Piel

951-653-5566j.piel@imedsonline.com

Locations

Jackson Eye, S.C

Recruiting

Lake Villa, Illinois, United States

Contacts

Jenna Piel

951-653-5566j.piel@imedsonline.com

Principal Investigator:

Mitch Jackson, MD

Pepose Vision Institute

Recruiting

Chesterfield, Missouri, United States

Contacts

Jenna Piel

951-653-5566j.piel@imedsonline.com

Principal Investigator:

Jay Pepose, MD

More Information

Sponsor

Innovative Medical

Last update posted

Jun 14, 2012

Last verified

Jun, 2012

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Innovative Medical on 2012-06-14.