Evaluating the Efficacy of Dry Eye (DE) Disease Treatment Using Novel Tear Film Imager (TFI)

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Device: Tear Film Imager

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:

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Shaare Zedek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dry Eye Disease; Subjects who will be diagnosed at baseline with Dry Eye Disease according to standard diagnosis	Device: Tear Film Imager; Tear Film Imager recording
Active Comparator: Healthy; Subjects who will be diagnosed at baseline with no Dry Eye Disease according to standard diagnosis	Device: Tear Film Imager; Tear Film Imager recording

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Adom Advanced Optical Technologies Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2020
• Primary Completion (Actual): September 23, 2021
• Study Completion (Actual): September 23, 2021

Study Registration Dates

• First Submitted: November 29, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 10, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: SZMC-TFI-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No