Contact AllergyINTACNCT04240587
Intranasal Neurostimulation for the Treatment of Neurosensory Abnormalities in CL Wearers (INTAC)
A study testing TrueTear™ intranasal neurostimulator (ITN) in people with Contact Allergy and Neuropathic Pain, run by Tufts Medical Center at 1 site in United States.
Trial summary
To find out if the use of an intranasal tear neurostimulator (ITN), may be useful in decreasing the pain symptoms felt by patients who experience contact lens discomfort. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Contact Allergy, Neuropathic Pain
- What is being tested?
- TrueTear™ intranasal neurostimulator (ITN)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2020to 3 Nov 2021
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 21 years of age at screening visit
- Ocular Surface Disease Index (OSDI) score of less than 12 (without contact lens wear)
- Contact Lens Dry Eye Questionnaire (CLDEQ)-8 score of greater than 12.18
- Regular contact lens wearer who wears them less than 6 hours per day due to discomfort
- The presence of at least one microneuroma on in vivo confocal microscopy
- Self-reported good compliance with healthy contact lens regimen (replace contact lenses per manufacturer's recommendations, use of multipurpose or hydrogen peroxide contact lens solution nightly)
Show all 9Show fewer
- Have had an eye exam within the last two years that included dispense of a contact lens prescription
- Proparacaine drops relieve at least 75% of ocular symptoms to ensure that patients do not have centralized neuropathic corneal pain
- If a soft lens wearer, use a contact lens that was released within the last 15 years
Who cannot join
- Use of topical drops other than artificial tear substitutes
- Ocular surgery or other ocular disease within 3 months prior to study enrollment
- Concurrent ocular disease that may impact results
- Have dry eye (as defined by 2 or more of the parameters below)
- Schirmer's wetting test < 10mm
- TBUT <7sec
Show all 21Show fewer
- NEI scale corneal staining of 4 out of 15 at the time of enrollment
- Improper CL fit
- No microneuroma by in vivo confocal microscopy
- Overnight wear within 1 month of screening visit
- Use of colored or cosmetic lenses
- Contra-indication to ITN
- Chronic or recurrent epistaxis, coagulation disorders.
- Nasal or sinus surgery or significant trauma to the nose.
- Cardiac demand pacemaker, implanted defibrillator, or other implanted electronic device in the head or neck.
- Chronic or recurrent nosebleeds
- Bleeding disorder
- Known hypersensitivity (allergy) to the hydrogel material
- Disabling arthritis, neuropathy, or limited motor coordination affecting self-handling of the device.
- History of migraines
- Under 21 years of age
Trial locations and contacts
1 site in 1 country.
About this study
To find out if the use of an intranasal tear neurostimulator (ITN), may be useful in decreasing the pain symptoms felt by patients who experience contact lens discomfort.
- Conditions
- Contact Allergy, Neuropathic Pain
- Being tested
- TrueTear™ intranasal neurostimulator (ITN)
- Keywords
- Contact Lens Discomfort
- Medical subject headings
- Dermatitis, Allergic Contact, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrueTear™ intranasal neurostimulator (ITN)Device
The ITN delivers small electrical currents to the inner cavity of the nose, gently activating nerves that stimulate the body's natural tear production system. Those in the ITN "active" arm will receive the active tips which contain the current from the base to the nasociliary nerve. Those in the ITN "sham" arm will receive tips without the current.
| Study group | Role | What they receive |
|---|---|---|
| TrueTear™ intranasal neurostimulator (ITN) Active Arm | Active comparator | TrueTear™ intranasal neurostimulator (ITN) with active tips - The tips carry the current from the base to the nasociliary nerve. Receives: Device: TrueTear™ intranasal neurostimulator (ITN) |
| TrueTear™ intranasal neurostimulator (ITN) Placebo/Sham Arm | Placebo comparator | TrueTear™ intranasal neurostimulator (ITN) with sham tips - The "sham" tips and do not properly carry the current. Receives: Device: TrueTear™ intranasal neurostimulator (ITN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the decrease in microneuromas by means of in vivo confocal microscopy (IVCM) among CLD subjects following treatment
Measured: 3 months
To measure the changes in the level of discomfort/pain after instillation of hyperosmolarity drops among CLD subjects following treatment
Measured: 3 months
To measure changes in Contact Lens Dry Eye Questionnaire (CLDEQ)-8 among CLD subjects using ITN.
Measured: 3 months
Secondary outcomes (2)
To access the corneal dendritic cells (DC) density by means of IVCM among CLD subjects before and after treatment.
Measured: 3 months
To evaluate the change in wearing time and comfortable wearing time from baseline to the final visit.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start23 Mar 2020
- Primary completion3 Nov 2021
- Study completion3 Nov 2021
Why it stopped: Difficulty in enrollment of study participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact AllergyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- CooperVision, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240587
- Sponsor's protocol ID
- STUDY00000080
- Acronym
- INTAC
- Status last verified
- Nov 2021
- First submitted
- 21 Jan 2020
- Last updated
- 11 Nov 2021
- Results posted
- No
- 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 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Neurostimulation for the Treatment of Neurosensory Abnormalities in CL Wearers (INTAC)
- ClinicalTrials.gov ID
- NCT04240587
- Acronym / sponsor ID
- INTAC / STUDY00000080
- Conditions
- Contact Allergy, Neuropathic Pain
- Keywords
- Contact Lens Discomfort
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty in enrollment of study participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- CooperVision, Inc.
- Study start
- 23 Mar 2020 (actual)
- Primary completion
- 3 Nov 2021 (actual)
- Study completion
- 3 Nov 2021 (actual)
- First posted
- 27 Jan 2020 (actual)
- 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.
To find out if the use of an intranasal tear neurostimulator (ITN), may be useful in decreasing the pain symptoms felt by patients who experience contact lens discomfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TrueTear™ intranasal neurostimulator (ITN) Active Arm | Active comparator | Device: TrueTear™ intranasal neurostimulator (ITN)TrueTear™ intranasal neurostimulator (ITN) with active tips - The tips carry the current from the base to the nasociliary nerve. |
| TrueTear™ intranasal neurostimulator (ITN) Placebo/Sham Arm | Placebo comparator | Device: TrueTear™ intranasal neurostimulator (ITN)TrueTear™ intranasal neurostimulator (ITN) with sham tips - The "sham" tips and do not properly carry the current. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At least 21 years of age at screening visit
- Ocular Surface Disease Index (OSDI) score of less than 12 (without contact lens wear)
- Contact Lens Dry Eye Questionnaire (CLDEQ)-8 score of greater than 12.18
- Regular contact lens wearer who wears them less than 6 hours per day due to discomfort
- The presence of at least one microneuroma on in vivo confocal microscopy
Key exclusion criteria (21 listed)
- Use of topical drops other than artificial tear substitutes
- Ocular surgery or other ocular disease within 3 months prior to study enrollment
- Concurrent ocular disease that may impact results
- Have dry eye (as defined by 2 or more of the parameters below)
- NEI scale corneal staining of 4 out of 15 at the time of enrollment
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 |
|---|---|---|
| TrueTear™ intranasal neurostimulator (ITN)The ITN delivers small electrical currents to the inner cavity of the nose, gently activating nerves that stimulate the body's natural tear production system. Those in the ITN "active" arm will receive the active tips which contain the current from the base to the nasociliary nerve. Those in the ITN "sham" arm will receive tips without the current. | Device | TrueTear™ intranasal neurostimulator (ITN) Active Arm, TrueTear™ intranasal neurostimulator (ITN) Placebo/Sham Arm |
Primary outcome
To evaluate the decrease in microneuromas by means of in vivo confocal microscopy (IVCM) among CLD subjects following treatment
Time frame: 3 months
To measure the changes in the level of discomfort/pain after instillation of hyperosmolarity drops among CLD subjects following treatment
Time frame: 3 months
To measure changes in Contact Lens Dry Eye Questionnaire (CLDEQ)-8 among CLD subjects using ITN.
Time frame: 3 months
2 secondary outcomes
To access the corneal dendritic cells (DC) density by means of IVCM among CLD subjects before and after treatment.
Time frame: 3 months
To evaluate the change in wearing time and comfortable wearing time from baseline to the final visit.
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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™ intranasal neurostimulator (ITN) in people with Contact Allergy and Neuropathic Pain, run by Tufts Medical Center 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 9 inclusion and 21 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: withdrawn, as of the sponsor's last update on 11 Nov 2021. 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. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
To evaluate the decrease in microneuromas by means of in vivo confocal microscopy (IVCM) among CLD subjects following treatment (time frame: 3 months). The study lists 3 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 11 Nov 2021.