Skip to main content
OpenTrials
Completed

NCT Number: NCT04670263

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Shaare Zedek Medical Center

Jerusalem, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tear Film Imager

Device

Tear Film Imager recording

Primary outcomes

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

    Time frame: 1month

    Tear film imager meuresmend will be assessed during the study visits

  2. Verify repeatability of Tear film imager measurement

    Time frame: 2 hours

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

  3. Compare the clinical measurements of DES to the TFI measurements

    Time frame: 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 outcomes

  1. Changes in the lipid layer thickness

    Time frame: from baseline to 1 month

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

  2. Changes in the Macu-aqueous layer thickness

    Time frame: from baseline to 1 month

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

Sponsors and collaborators

Lead sponsor

Adom Advanced Optical Technologies Ltd.

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 17, 2020
Registry last updated
Jul 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.