Visual Display Users With Previously Undiagnosed Dry EyeNCT04763018
Study of External Neuromodulation to Improve Signs and Symptoms of Dry Eye in Visual Display Terminal Users
A study testing iTEAR100 in people with Visual Display Users With Previously Undiagnosed Dry Eye, run by Olympic Ophthalmics, Inc. at 1 site in United States.
Trial summary
Two study arms - sham and treatment; There will be a cross over of the sham group to the treatment group at day 15. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Visual Display Users With Previously Undiagnosed Dry Eye
- What is being tested?
- iTEAR100
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2021to 1 Jun 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 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 6hrs visual display terminal
- OSDI > 13
- One of: SChirmer < 10, One quadrant staining > 2, or Meibomian Gland expression <12
Who cannot join
- Opinion of investigator that subject not be in the study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Fishman Vision
Palo Alto, California, 94301
About this study
Official title: A Randomized Sham Controlled Study of External Neuromodulation to Improve Signs and Symptoms of Dry Eye in Visual Display Terminal Users
Two study arms - sham and treatment; There will be a cross over of the sham group to the treatment group at day 15.
Read the detailed description
This is a post market study. The active device will be the FDA cleared device used within its labeling. The sham group will receive an iTEAR device which looks identical to and makes noise similar to a fully functional iTEAR device but has a tip that does not vibrate. All subjects in the sham group will crossover to the treatment group after 2 two weeks and all patients will continue to 30 days.
The study will be conducted at up to 5 sites in the United States. It will enroll 30 subjects for 30 days.
This is a double-masked study with 10 subjects receiving sham and 20 subjects receiving treatment. The subjects and the examining investigators are masked to treatment until the crossover.
- Being tested
- iTEAR100
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTEAR100Device
Neurostimulation external nasal nerve to stimulate tear production
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | This arm will receive a function iTEAR Receives: Device: iTEAR100 |
| Sham | Sham comparator | This arm will receive sham treatment device Receives: Device: iTEAR100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meibomian Gland change in expressibility
Change in gland expression from meibomian glands
Measured: 14 days
Corneal Staining
Change in Staining of cornea
Measured: 14 days
Basal tear output
Change in the basal output of tears
Measured: 14 days
Secondary outcomes (1)
Safety
Incidence of Events which prevent device usage
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start17 Feb 2021 (estimated)
- Primary completion1 May 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual Display Users With Previously Undiagnosed 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
- Randomised
- Intervention model
- Crossover
- Model description
- Day 14-30, all subjects receive therapy device
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olympic Ophthalmics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763018
- Sponsor's protocol ID
- CLP-OO8
- Status last verified
- Feb 2021
- First submitted
- 14 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All results will be shared at conclusion of last follow up visit
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Sham Controlled Study of External Neuromodulation to Improve Signs and Symptoms of Dry Eye in Visual Display Terminal Users
- ClinicalTrials.gov ID
- NCT04763018
- Acronym / sponsor ID
- CLP-OO8
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Olympic Ophthalmics, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Feb 2021 (estimated)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 21 Feb 2021 (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.
Two study arms - sham and treatment; There will be a cross over of the sham group to the treatment group at day 15.
Detailed description
This is a post market study. The active device will be the FDA cleared device used within its labeling. The sham group will receive an iTEAR device which looks identical to and makes noise similar to a fully functional iTEAR device but has a tip that does not vibrate. All subjects in the sham group will crossover to the treatment group after 2 two weeks and all patients will continue to 30 days.
The study will be conducted at up to 5 sites in the United States. It will enroll 30 subjects for 30 days.
This is a double-masked study with 10 subjects receiving sham and 20 subjects receiving treatment. The subjects and the examining investigators are masked to treatment until the crossover.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Day 14-30, all subjects receive therapy device
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Device: iTEAR100This arm will receive a function iTEAR |
| Sham | Sham comparator | Device: iTEAR100This arm will receive sham treatment device |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- > 6hrs visual display terminal
- OSDI > 13
- One of: SChirmer < 10, One quadrant staining > 2, or Meibomian Gland expression <12
Key exclusion criteria (1 listed)
- Opinion of investigator that subject not be in the study
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 |
|---|---|---|
| iTEAR100Neurostimulation external nasal nerve to stimulate tear production | Device | Sham, Treatment |
Primary outcome
Meibomian Gland change in expressibility
Time frame: 14 days
Change in gland expression from meibomian glands
Corneal Staining
Time frame: 14 days
Change in Staining of cornea
Basal tear output
Time frame: 14 days
Change in the basal output of tears
1 secondary outcome
Safety
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Individual participant dataSharing planned: Yes. All results will be shared at conclusion of last follow up visit
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iTEAR100 in people with Visual Display Users With Previously Undiagnosed Dry Eye, run by Olympic Ophthalmics, 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 1 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 21 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael gertner, MD (650-283-9388, mgertner@oo-med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meibomian Gland change in expressibility (time frame: 14 days). 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 21 Feb 2021.