Dry Eye DiseasePhase 2/3NCT04670263
Evaluating the Efficacy of Dry Eye (DE) Disease Treatment Using Novel Tear Film Imager (TFI)
A Phase 2/3 study testing Tear Film Imager in people with Dry Eye Disease, run by Adom Advanced Optical Technologies Ltd. at 1 site in Israel.
Trial summary
Dry Eye disease signs and symptoms are reduced in patients who receive topical steroids and topical hyaluronic acid. AdOM's Tear Film Imager measurements are reproducible and it can diagnose the dry eye disease state in a single, non-invasive measurement. 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 Disease
- What is being tested?
- Tear Film Imager
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- 8 Mar 2020to 23 Sep 2021
- Phase
- Phase 2/3
- 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
- Signed informed consent form.
- Be at least 18 years of age at the time of enrollment of either sex or any race.
- Best corrected visual acuity (BCVA) of 0.7 logMAR (ie, 20/100 vision) or better in each eye as measured using a Snellen chart
- Intraocular pressure (IOP) in the range of 5 to 22 mmHg in both eyes.
- DE subjects will be enrolled if they manifest symptoms (OSDI >=13) and signs of clinically active dry eye disease in either eye, by at least one of:
- Corneal fluorescein staining - at least severe in one section or moderate at two
Show all 13Show fewer
- TBUT =< 10 sec
- Schirmer wetting of less than 10 mm in 5 min (with anesthesia).
- Control will be enrolled if they manifest NO symptoms (OSDI <13) and NO signs of clinically active dry eye disease in either eye, by meeting all the following criteria's:
- Corneal fluorescein staining - negative
- TBUT > 10
- Schirmer wetting of more than 10 mm in 5 min (with anesthesia).
- A negative urine pregnancy test if female of childbearing potential.
Who cannot join
- Any ocular condition that could affect study parameters (glaucoma, nystagmus, keratoconus, follicular conjunctivitis, iritis or post LASIK, LASEK or PRK).
- Have had any ocular infection within the last 30 days and/or have preauricular lymphadenopathy.
- Any significant illness that could be expected to interfere with study parameters.
- Use of any investigational product or device within one month prior to Visit 1 or during the study period.
- Concomitant use of any prohibited medication (antihistamines, corticosteroids, all ocular medications or anti-allergic therapies) during the trial.
- Any history of, positive HIV, hepatitis B, C, or evidence of acute active hepatitis A (anti HAV IgM), Any known history of iritis/uveitis, glaucoma, or other chronic ophthalmologic disorder other than allergic conjunctivitis.
- History of any ocular surgical procedure within 3 months prior to Visit 1.
Trial locations and contacts
1 site in 1 country.
About this study
Dry Eye disease signs and symptoms are reduced in patients who receive topical steroids and topical hyaluronic acid.
AdOM's Tear Film Imager measurements are reproducible and it can diagnose the dry eye disease state in a single, non-invasive measurement. The Tear Film Imager can provide objective accurate measurements of the dry eye treatment effectiveness.
Read the detailed description
80 subjects will be enrolled , 40 of which with positive signs and symptoms of Dry eye and 40 healthy subjects without sign and no symptoms of Dry eye. Healthy and Dry eye groups will be age- matched.
Over a period of 4 weeks, the subjects diagnosed with dry eye will be treated and as follows:
- Hylo-comod artificial tears (0.1 % sodium hyaluronate) 8 times a day for 4 weeks
- Coll STERODEX (Dexamethasone sodium phosphate 0.1% eye drops) 3 times a day for 2 weeks Healthy subjects will not receive any treatment.
Both groups will be examined at baseline and 4 weeks after baseline measurement.
Treatment results will be measured by both traditional methods and by Tear Film Imager.
- Conditions
- Dry Eye Disease
- Being tested
- Tear Film Imager
- 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.
Tear Film ImagerDevice
Tear Film Imager recording
| Study group | Role | What they receive |
|---|---|---|
| Dry Eye Disease | Experimental | Subjects who will be diagnosed at baseline with Dry Eye Disease according to standard diagnosis Receives: Device: Tear Film Imager |
| Healthy | Active comparator | Subjects who will be diagnosed at baseline with no Dry Eye Disease according to standard diagnosis Receives: Device: Tear Film Imager |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear film imager measurements with be assessed for reference values for objective tests of the disease with the Tear Film Imager
Tear film imager meuresmend will be assessed during the study visits
Measured: 1month
Verify repeatability of Tear film imager measurement
The repeatability of TFI will be evaluated by comparing the reported parameters of the two TFI measurements on first visit
Measured: 2 hours
Compare the clinical measurements of DES to the TFI measurements
The correlation between the clinician's measurements of Dry Eye and the corresponding Tear film imager reported parameters of interest will used to evaluate the association between the two assessments.
Measured: 1month
Secondary outcomes (2)
Changes in the lipid layer thickness
Change from baseline of the lipid layer thickness as measured by the Tear film imager
Measured: from baseline to 1 month
Changes in the Macu-aqueous layer thickness
Change from baseline of the Muco-aqueous layer thickness as measured by Tear film imager
Measured: from baseline to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start8 Mar 2020
- Primary completion23 Sep 2021
- Study completion23 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies 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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adom Advanced Optical Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670263
- Sponsor's protocol ID
- SZMC-TFI-2019
- Status last verified
- Feb 2022
- First submitted
- 29 Nov 2020
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Dry Eye (DE) Disease Treatment Using Novel Tear Film Imager (TFI)
- ClinicalTrials.gov ID
- NCT04670263
- Acronym / sponsor ID
- SZMC-TFI-2019
- Conditions
- Dry Eye Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Adom Advanced Optical Technologies Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Mar 2020 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 17 Dec 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.
Dry Eye disease signs and symptoms are reduced in patients who receive topical steroids and topical hyaluronic acid.
AdOM's Tear Film Imager measurements are reproducible and it can diagnose the dry eye disease state in a single, non-invasive measurement. The Tear Film Imager can provide objective accurate measurements of the dry eye treatment effectiveness.
Detailed description
80 subjects will be enrolled , 40 of which with positive signs and symptoms of Dry eye and 40 healthy subjects without sign and no symptoms of Dry eye. Healthy and Dry eye groups will be age- matched.
Over a period of 4 weeks, the subjects diagnosed with dry eye will be treated and as follows:
- Hylo-comod artificial tears (0.1 % sodium hyaluronate) 8 times a day for 4 weeks
- Coll STERODEX (Dexamethasone sodium phosphate 0.1% eye drops) 3 times a day for 2 weeks Healthy subjects will not receive any treatment.
Both groups will be examined at baseline and 4 weeks after baseline measurement.
Treatment results will be measured by both traditional methods and by Tear Film Imager.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Eye Disease | Experimental | Device: Tear Film ImagerSubjects who will be diagnosed at baseline with Dry Eye Disease according to standard diagnosis |
| Healthy | Active comparator | Device: Tear Film ImagerSubjects who will be diagnosed at baseline with no Dry Eye Disease according to standard diagnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed informed consent form.
- Be at least 18 years of age at the time of enrollment of either sex or any race.
- Best corrected visual acuity (BCVA) of 0.7 logMAR (ie, 20/100 vision) or better in each eye as measured using a Snellen chart
- Intraocular pressure (IOP) in the range of 5 to 22 mmHg in both eyes.
- DE subjects will be enrolled if they manifest symptoms (OSDI >=13) and signs of clinically active dry eye disease in either eye, by at least one of:
Key exclusion criteria (7 listed)
- Any ocular condition that could affect study parameters (glaucoma, nystagmus, keratoconus, follicular conjunctivitis, iritis or post LASIK, LASEK or PRK).
- Have had any ocular infection within the last 30 days and/or have preauricular lymphadenopathy.
- Any significant illness that could be expected to interfere with study parameters.
- Use of any investigational product or device within one month prior to Visit 1 or during the study period.
- Concomitant use of any prohibited medication (antihistamines, corticosteroids, all ocular medications or anti-allergic therapies) during the trial.
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 |
|---|---|---|
| Tear Film ImagerTear Film Imager recording | Device | Dry Eye Disease, Healthy |
Primary outcome
Tear film imager measurements with be assessed for reference values for objective tests of the disease with the Tear Film Imager
Time frame: 1month
Tear film imager meuresmend will be assessed during the study visits
Verify repeatability of Tear film imager measurement
Time frame: 2 hours
The repeatability of TFI will be evaluated by comparing the reported parameters of the two TFI measurements on first visit
Compare the clinical measurements of DES to the TFI measurements
Time frame: 1month
The correlation between the clinician's measurements of Dry Eye and the corresponding Tear film imager reported parameters of interest will used to evaluate the association between the two assessments.
2 secondary outcomes
Changes in the lipid layer thickness
Time frame: from baseline to 1 month
Changes in the Macu-aqueous layer thickness
Time frame: from baseline to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- 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 Phase 2/3 study testing Tear Film Imager in people with Dry Eye Disease, run by Adom Advanced Optical Technologies 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 13 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 12 Jul 2022. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tear film imager measurements with be assessed for reference values for objective tests of the disease with the Tear Film Imager (time frame: 1month). 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 12 Jul 2022.