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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01386073
Other study ID # Focus2011-001
Secondary ID
Status Recruiting
Phase Phase 4
First received June 29, 2011
Last updated June 13, 2012
Start date July 2011
Est. completion date November 2012

Study information

Verified date June 2012
Source Innovative Medical
Contact Jenna Piel
Phone 951-653-5566
Email j.piel@imedsonline.com
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
FreshKote
Three times a day for three months
Systane
three times a day for three months

Locations

Country Name City State
United States Pepose Vision Institute Chesterfield Missouri
United States Jackson Eye, S.C Lake Villa Illinois

Sponsors (1)

Lead Sponsor Collaborator
Innovative Medical

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary TBUT Test that measures how long it takes for the tears to break up Three months No
Primary Best Corrected Visual Acuity Vision obtained with the best possible lens correction (glasses or contact lenses) Three months No
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