Dry Eye Disease Clinical Trial
Official title:
Evaluating the Efficacy of Dry Eye (DE) Disease Treatment Using Novel Tear Film Imager (TFI)
Verified date | February 2022 |
Source | Adom Advanced Optical Technologies Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Israel | Shaare Zedek Medical Center | Jerusalem |
Lead Sponsor | Collaborator |
---|---|
Adom Advanced Optical Technologies Ltd. |
Israel,
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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