Dry Eye SyndromesNCT05741398
Evaluation of Optical System in the Treatment of - Dry Eye Disease
A study testing VR system by Demaod in people with Dry Eye Syndromes, run by Demaod Ltd at 1 site in Israel.
Trial summary
Single-center, Prospective, Open Label, with Before-After Study Design, to evaluate the safety and efficacy of the optical system in the treatment of dry eye disease. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- VR system by Demaod
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jun 2023to 30 Dec 2023
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and older of any gender or race.
- Provide written informed consent before study participation.
- Willingness and ability to return for all study visits.
- Ocular Surface Disease Index (OSDI) questionnaire and a score of ≥ 23 at the baseline visit.
- Tear break-up time (TBUT) <10 seconds in both eyes.
- Agreement/ability to abstain from dry eye/MGD medications for the time between the treatment visit/s and the final study visit. Ocular lubricants are allowed if no changes are made during the study.
Who cannot join
- History of ocular surgery including intraocular, oculoplastic, corneal or refractive surgery within 1 year.
- Patients with giant papillary conjunctivitis.
- Patients with punctal plugs or who have had punctal cautery.
- Ocular injury or trauma, chemical burns, or limbal stem cell deficiency within 3 months of the baseline examination.
- Active ocular herpes zoster or simplex of eye or eyelid or a history of these within the last 3 months.
- Aphakic Patients.
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- Cicatricial lid margin disease identified via slit lamp examination, including pemphigoid, symblepharon, etc.
- Active ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac, or eyelids including a hordeolum or stye).
- Active ocular inflammation or history of chronic, recurrent ocular inflammation within 3 months (e.g., retinitis, macular inflammation, choroiditis, uveitis, iritis, scleritis, episcleritis, keratitis).
- Criteria:
- -
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Haemek Medical Center
Afula, 3824674
Daniel Briscoe, MD, 050-4439421, dr.danielbriscoe@gmail.com
About this study
Official title: Evaluation of the Efficacy and Safety of Optical System in the Treatment of - Dry Eye Disease (DED) Pilot Study
Single-center, Prospective, Open Label, with Before-After Study Design, to evaluate the safety and efficacy of the optical system in the treatment of dry eye disease.
Read the detailed description
Single-center, Prospective, Open Label, with Before-After Study Design. Up to 15 subjects will be enrolled in the study to provide at least 10 evaluable subjects.
All subjects will undergo 3 treatments two weeks apart (2 weeks (+/-3 days) from the previous treatment).
Follow-up visits after the last treatment visit: 4 weeks (±7 days), 12 weeks (±7 days).
- Conditions
- Dry Eye Syndromes
- Being tested
- VR system by Demaod
- 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.
VR system by DemaodDevice
non-invasive light pulse generated by a non-contacting device for the treatment of the symptoms of dry eyes and MDG
| Study group | Role | What they receive |
|---|---|---|
| Demaod VR system tratment | Experimental | Non-invasive light pulse generated by a non-contacting device for treating the symptoms of dry eyes and MDG. Receives: Device: VR system by Demaod |
What is being measured
The primary outcome is the main question the study is designed to answer.
4 weeks TBUT change from baseline
Change from baseline to the 4-week follow-up exam in Tear Break Up Times (TBUT), as assessed by a rater.
Measured: up to 4 weeks post last treatment
Secondary outcomes (2)
OSDI changes from baseline to 4 and 12 weeks FU
Change from baseline in patient symptoms using Ocular Surface Disease Index (OSDI) at 4-weeks and 12-weeks follow-up exam.
Measured: up to 12 weeks post last treatment
12 weeks TBUT change from baseline
Changes from baseline to the 12-week follow-up exam in Tear Break Up Times (TBUT), as assessed by a rater.
Measured: 12 weeks post last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start1 Jun 2023
- Primary completion1 Nov 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies 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
- Model description
- Single-center, Prospective, Open Label, with Before-After Study Design
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Demaod Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741398
- Sponsor's protocol ID
- CLN 0100
- Status last verified
- Feb 2023
- First submitted
- 14 Feb 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Optical System in the Treatment of - Dry Eye Disease (DED) Pilot Study
- ClinicalTrials.gov ID
- NCT05741398
- Acronym / sponsor ID
- CLN 0100
- Conditions
- Dry Eye Syndromes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Demaod LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 23 Feb 2023 (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.
Single-center, Prospective, Open Label, with Before-After Study Design, to evaluate the safety and efficacy of the optical system in the treatment of dry eye disease.
Detailed description
Single-center, Prospective, Open Label, with Before-After Study Design. Up to 15 subjects will be enrolled in the study to provide at least 10 evaluable subjects.
All subjects will undergo 3 treatments two weeks apart (2 weeks (+/-3 days) from the previous treatment).
Follow-up visits after the last treatment visit: 4 weeks (±7 days), 12 weeks (±7 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center, Prospective, Open Label, with Before-After Study Design
| Arm | Type | Receives |
|---|---|---|
| Demaod VR system tratment | Experimental | Device: VR system by DemaodNon-invasive light pulse generated by a non-contacting device for treating the symptoms of dry eyes and MDG. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years and older of any gender or race.
- Provide written informed consent before study participation.
- Willingness and ability to return for all study visits.
- Ocular Surface Disease Index (OSDI) questionnaire and a score of ≥ 23 at the baseline visit.
- Tear break-up time (TBUT) <10 seconds in both eyes.
Key exclusion criteria (11 listed)
- History of ocular surgery including intraocular, oculoplastic, corneal or refractive surgery within 1 year.
- Patients with giant papillary conjunctivitis.
- Patients with punctal plugs or who have had punctal cautery.
- Ocular injury or trauma, chemical burns, or limbal stem cell deficiency within 3 months of the baseline examination.
- Active ocular herpes zoster or simplex of eye or eyelid or a history of these within the last 3 months.
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 |
|---|---|---|
| VR system by Demaodnon-invasive light pulse generated by a non-contacting device for the treatment of the symptoms of dry eyes and MDG | Device | Demaod VR system tratment |
Primary outcome
4 weeks TBUT change from baseline
Time frame: up to 4 weeks post last treatment
Change from baseline to the 4-week follow-up exam in Tear Break Up Times (TBUT), as assessed by a rater.
2 secondary outcomes
OSDI changes from baseline to 4 and 12 weeks FU
Time frame: up to 12 weeks post last treatment
12 weeks TBUT change from baseline
Time frame: 12 weeks post last treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR system by Demaod in people with Dry Eye Syndromes, run by Demaod Ltd at 1 site in Israel.
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 11 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 27 Jun 2023. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hila Kfir, b.sc (0523313350, Kfirclinical@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4 weeks TBUT change from baseline (time frame: up to 4 weeks post last treatment). 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 27 Jun 2023.