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

Phase 2

Completed

• Conditions: Dry Eye Disease
• Interventions: Device: Tear Film Imager

• Registration Number: NCT04670263
• Lead Sponsor: Adom Advanced Optical Technologies Ltd.

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 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:

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 Timeline

• Study Start: 2020-03-08
• Study First Submitted: 2020-11-29
• Study First Submitted QC: 2020-12-15
• Study First Posted: 2020-12-17
• Primary Completion: 2021-09-23
• Study Completion: 2021-09-23
• Status Verified: 2022-02
• Last Update Submitted: 2022-07-10
• Last Update Posted: 2022-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy	Tear Film Imager	Subjects who will be diagnosed at baseline with no Dry Eye Disease according to standard diagnosis
Dry Eye Disease	Tear Film Imager	Subjects who will be diagnosed at baseline with Dry Eye Disease according to standard diagnosis

Primary Outcome Measures

Name	Time	Method
Tear film imager measurements with be assessed for reference values for objective tests of the disease with the Tear Film Imager	1month	Tear film imager meuresmend will be assessed during the study visits
Verify repeatability of Tear film imager measurement	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	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.

Secondary Outcome Measures

Name	Time	Method
Changes in the lipid layer thickness	from baseline to 1 month	Change from baseline of the lipid layer thickness as measured by the Tear film imager
Changes in the Macu-aqueous layer thickness	from baseline to 1 month	Change from baseline of the Muco-aqueous layer thickness as measured by Tear film imager

Trial Locations

Locations (1)

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel