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

NCT04670263 | Completed Phase 2

• 1 other identifier: SZMC-TFI-2019
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Changes in the lipid layer thickness

  from baseline to 1 month

• Changes in the Macu-aqueous layer thickness

  from baseline to 1 month

Study Arms (2)

Dry Eye Disease

EXPERIMENTAL

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

Device: Tear Film Imager

Healthy

ACTIVE COMPARATOR

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

Device: Tear Film Imager

Interventions

Tear Film Imager DEVICE

Tear Film Imager recording

Dry Eye Disease; Healthy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adom Advanced Optical Technologies Ltd.: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2020
• First Posted: December 17, 2020
• Study Start: March 8, 2020
• Primary Completion: September 23, 2021
• Study Completion: September 23, 2021
• Last Updated: July 12, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)