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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04670263
Other study ID # SZMC-TFI-2019
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date March 8, 2020
Est. completion date September 23, 2021

Study information

Verified date February 2022
Source Adom Advanced Optical Technologies Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. The Tear Film Imager can provide objective accurate measurements of the dry eye treatment effectiveness.


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: 1. Hylo-comod artificial tears (0.1 % sodium hyaluronate) 8 times a day for 4 weeks 2. 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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date September 23, 2021
Est. primary completion date September 23, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Signed informed consent form. 2. Be at least 18 years of age at the time of enrollment of either sex or any race. 3. Best corrected visual acuity (BCVA) of 0.7 logMAR (ie, 20/100 vision) or better in each eye as measured using a Snellen chart 4. Intraocular pressure (IOP) in the range of 5 to 22 mmHg in both eyes. 5. 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: 1. Corneal fluorescein staining - at least severe in one section or moderate at two 2. TBUT =< 10 sec 3. Schirmer wetting of less than 10 mm in 5 min (with anesthesia). 6. 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: 1. Corneal fluorescein staining - negative 2. TBUT > 10 3. Schirmer wetting of more than 10 mm in 5 min (with anesthesia). 7. A negative urine pregnancy test if female of childbearing potential. Exclusion Criteria: 1. Any ocular condition that could affect study parameters (glaucoma, nystagmus, keratoconus, follicular conjunctivitis, iritis or post LASIK, LASEK or PRK). 2. Have had any ocular infection within the last 30 days and/or have preauricular lymphadenopathy. 3. Any significant illness that could be expected to interfere with study parameters. 4. Use of any investigational product or device within one month prior to Visit 1 or during the study period. 5. Concomitant use of any prohibited medication (antihistamines, corticosteroids, all ocular medications or anti-allergic therapies) during the trial. 6. 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. 7. History of any ocular surgical procedure within 3 months prior to Visit 1.

Study Design


Intervention

Device:
Tear Film Imager
Tear Film Imager recording

Locations

Country Name City State
Israel Shaare Zedek Medical Center Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Adom Advanced Optical Technologies Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1month
Primary 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 2 hours
Primary 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. 1month
Secondary Changes in the lipid layer thickness Change from baseline of the lipid layer thickness as measured by the Tear film imager from baseline to 1 month
Secondary Changes in the Macu-aqueous layer thickness Change from baseline of the Muco-aqueous layer thickness as measured by Tear film imager from baseline to 1 month
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