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

Primary Purpose

Dry Eye Disease

Status

Completed

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Tear Film Imager

About this trial

This is an interventional diagnostic trial for Dry Eye Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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:
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).
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).
A negative urine pregnancy test if female of childbearing potential.

Exclusion Criteria:

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.

Sites / Locations

Shaare Zedek Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry Eye Disease

Healthy

Arm Description

Subjects who will be diagnosed at baseline with Dry Eye Disease according to standard diagnosis

Subjects who will be diagnosed at baseline with no Dry Eye Disease according to standard diagnosis

Outcomes

Primary Outcome Measures

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

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

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.

Secondary Outcome Measures

Changes in the lipid layer thickness

Change from baseline of the lipid layer thickness as measured by the Tear film imager

Changes in the Macu-aqueous layer thickness

Change from baseline of the Muco-aqueous layer thickness as measured by Tear film imager

Full Information

NCT ID

NCT04670263

First Posted

November 29, 2020

Last Updated

July 10, 2022

Sponsor

Adom Advanced Optical Technologies Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04670263

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

March 8, 2020 (Actual)

Primary Completion Date

September 23, 2021 (Actual)

Study Completion Date

September 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Adom Advanced Optical Technologies Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

Blinding will take place at the reading center: the patient measurements will be unidentified. Adom's interpreter will not know to which group the examinee belonged to. After the conclusion of the study, the blindness will be removed, and a retrospective statistical analysis will be conducted.

Allocation

Non-Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dry Eye Disease

Arm Type

Experimental

Arm Description

Subjects who will be diagnosed at baseline with Dry Eye Disease according to standard diagnosis

Arm Title

Healthy

Arm Type

Active Comparator

Arm Description

Subjects who will be diagnosed at baseline with no Dry Eye Disease according to standard diagnosis

Intervention Type

Device

Intervention Name(s)

Tear Film Imager

Intervention Description

Tear Film Imager recording

Primary Outcome Measure Information:

Title

Tear film imager measurements with be assessed for reference values for objective tests of the disease with the Tear Film Imager

Description

Tear film imager meuresmend will be assessed during the study visits

Time Frame

1month

Title

Verify repeatability of Tear film imager measurement

Description

The repeatability of TFI will be evaluated by comparing the reported parameters of the two TFI measurements on first visit

Time Frame

2 hours

Title

Compare the clinical measurements of DES to the TFI measurements

Description

Time Frame

1month

Secondary Outcome Measure Information:

Title

Changes in the lipid layer thickness

Description

Change from baseline of the lipid layer thickness as measured by the Tear film imager

Time Frame

from baseline to 1 month

Title

Changes in the Macu-aqueous layer thickness

Description

Change from baseline of the Muco-aqueous layer thickness as measured by Tear film imager

Time Frame

from baseline to 1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Facility Information:

Facility Name

Shaare Zedek Medical Center

City

Jerusalem

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

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

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