Dry EyeNCT03097614
Dry Eye Symptom Relief Assessment With Use of TrueTear in a Controlled Adverse Environment
A study testing TrueTear in people with Dry Eye and Dry Eye Syndromes, run by Oculeve, Inc. at 1 site in United States.
Trial summary
This study characterizes acute dry eye symptom control, assessed during exposure to a Controlled Adverse Environment, following use of the TrueTear for 45 days. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Dry Eye, Dry Eye Syndromes
- What is being tested?
- TrueTear
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2017to 26 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to the Screening Visit
- Normal lid/lash anatomy, blinking function and closure as determined by the Investigator
- Literate, able to speak English, and able to complete questionnaires independently
Who cannot join
- Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the Investigator, may lead to risk of clinically significant increased bleeding
- Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
- Contact lens use within 7 days prior to the Screening Visit or anticipate the use of contact lenses at any time during the study
- Corneal transplant in either or both eyes
- Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head
- A woman who is pregnant, nursing an infant, or planning a pregnancy during the duration of the study
- Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to the Screening Visit
Trial locations and contacts
1 site in 1 country.
United States1 site
Andover Eye Associates
Andover, Massachusetts, 01810
About this study
Official title: Prospective, Single-Arm Clinical Trial to Evaluate Acute Dry Eye Symptom Relief Assessed During Exposure to a Controlled Adverse Environment (CAE®) Following a 45 Day Period With Application of TrueTear™
This study characterizes acute dry eye symptom control, assessed during exposure to a Controlled Adverse Environment, following use of the TrueTear for 45 days.
Read the detailed description
Subjects will be instructed to use the TrueTear daily for approximately 45 days with assessments in the Controlled Adverse Environment taking place on Day 0 and Day 45. Upon entering the CAE, participants will complete dry eye symptom questionnaires every five minutes and will administer the device when a certain level of ocular discomfort has been reached.
- Conditions
- Dry Eye, Dry Eye Syndromes
- Being tested
- TrueTear
- 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.
TrueTearDevice
The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.
| Study group | Role | What they receive |
|---|---|---|
| TrueTear | Experimental | The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system. Receives: Device: TrueTear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye Dryness Score
Eye Dryness Score using a visual analog scale assessed in the Controlled Adverse Environment (CAE). The participant rates their current eye dryness (both eyes simultaneously) by scoring 0 to indicate "no discomfort" and 100 to indicate "maximal discomfort". The assessment line length of the scale will be 100 mm.
Measured: Day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start31 Mar 2017
- Primary completion26 Jun 2017
- Study completion26 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oculeve, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gail Torkildsen, MD, Principal investigator, Andover Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097614
- Sponsor's protocol ID
- OCUN-029
- Status last verified
- Sep 2018
- First submitted
- 27 Mar 2017
- Last updated
- 18 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-Arm Clinical Trial to Evaluate Acute Dry Eye Symptom Relief Assessed During Exposure to a Controlled Adverse Environment (CAE®) Following a 45 Day Period With Application of TrueTear™
- ClinicalTrials.gov ID
- NCT03097614
- Acronym / sponsor ID
- OCUN-029
- Conditions
- Dry Eye, Dry Eye Syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Oculeve, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 26 Jun 2017 (actual)
- Study completion
- 26 Jun 2017 (actual)
- First posted
- 31 Mar 2017 (actual)
- Results
- Posted 19 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study characterizes acute dry eye symptom control, assessed during exposure to a Controlled Adverse Environment, following use of the TrueTear for 45 days.
Detailed description
Subjects will be instructed to use the TrueTear daily for approximately 45 days with assessments in the Controlled Adverse Environment taking place on Day 0 and Day 45. Upon entering the CAE, participants will complete dry eye symptom questionnaires every five minutes and will administer the device when a certain level of ocular discomfort has been reached.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TrueTear | Experimental | Device: TrueTearThe device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to the Screening Visit
- Normal lid/lash anatomy, blinking function and closure as determined by the Investigator
- Literate, able to speak English, and able to complete questionnaires independently
Key exclusion criteria (7 listed)
- Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the Investigator, may lead to risk of clinically significant increased bleeding
- Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
- Contact lens use within 7 days prior to the Screening Visit or anticipate the use of contact lenses at any time during the study
- Corneal transplant in either or both eyes
- Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head
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 |
|---|---|---|
| TrueTearThe device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system. | Device | TrueTear |
Primary outcome
Eye Dryness Score
Time frame: Day 45
Eye Dryness Score using a visual analog scale assessed in the Controlled Adverse Environment (CAE). The participant rates their current eye dryness (both eyes simultaneously) by scoring 0 to indicate "no discomfort" and 100 to indicate "maximal discomfort". The assessment line length of the scale will be 100 mm.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Gail Torkildsen, MD principal investigator
Andover Eye Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TrueTear in people with Dry Eye and Dry Eye Syndromes, run by Oculeve, Inc. at 1 site 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eye Dryness Score (time frame: Day 45). 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 18 Oct 2018.