Dry EyePhase 4NCT01386073
Efficacy of FreshKote and Systane for the Treatment of Dry Eye and Improvement of Osmolarity
A Phase 4 study testing FreshKote and Systane in people with Dry Eye, run by Innovative Medical at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- FreshKote and Systane
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2011to Nov 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Pepose Vision Institute
Chesterfield, Missouri
Jenna Piel, 951-653-5566, j.piel@imedsonline.com
Jay Pepose, MD
- Recruiting
Jackson Eye, S.C
Lake Villa, Illinois
Jenna Piel, 951-653-5566, j.piel@imedsonline.com
Mitch Jackson, MD
About this study
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
- Being tested
- FreshKote, Systane
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreshKoteDrug
Three times a day for three months
SystaneDrug
three times a day for three months
| Study group | Role | What they receive |
|---|---|---|
| FreshKote | Active comparator | Not described Receives: Drug: FreshKote |
| Systane | Placebo comparator | Not described Receives: Drug: Systane |
What is being measured
The primary outcome is the main question the study is designed to answer.
TBUT
Test that measures how long it takes for the tears to break up
Measured: Three months
Best Corrected Visual Acuity
Vision obtained with the best possible lens correction (glasses or contact lenses)
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovative Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jay Pepose, MD, Principal investigator, Pepose Vision InstituteMitch Jackson, MD, Principal investigator, Jackson Eye, S.C
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386073
- Sponsor's protocol ID
- Focus2011-001
- Status last verified
- Jun 2012
- First submitted
- 29 Jun 2011
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of FreshKote and Systane for the Treatment of Dry Eye and Improvement of Osmolarity
- ClinicalTrials.gov ID
- NCT01386073
- Acronym / sponsor ID
- Focus2011-001
- Conditions
- Dry Eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Innovative MedicalIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 30 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy of FreshKote and Systane for the reduction of dry eye signs and symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FreshKote | Active comparator | Drug: FreshKote |
| Systane | Placebo comparator | Drug: Systane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FreshKoteThree times a day for three months | Drug | FreshKote |
| Systanethree times a day for three months | Drug | Systane |
Primary outcome
TBUT
Time frame: Three months
Test that measures how long it takes for the tears to break up
Best Corrected Visual Acuity
Time frame: Three months
Vision obtained with the best possible lens correction (glasses or contact lenses)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay Pepose, MD principal investigator
Pepose Vision Institute
Mitch Jackson, MD principal investigator
Jackson Eye, S.C
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FreshKote and Systane in people with Dry Eye, run by Innovative Medical at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jenna Piel (951-653-5566, j.piel@imedsonline.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TBUT (time frame: Three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2012.