Status:
COMPLETED
Evaluating the Efficacy of Dry Eye (DE) Disease Treatment Using Novel Tear Film Imager (TFI)
Lead Sponsor:
Adom Advanced Optical Technologies Ltd.
Conditions:
Dry Eye Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 ...
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....
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2021
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04670263
Start Date
March 8 2020
End Date
September 23 2021
Last Update
July 12 2022
Active Locations (1)
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1
Shaare Zedek Medical Center
Jerusalem, Israel