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

Last updated: July 10, 2022
Sponsor: Adom Advanced Optical Technologies Ltd.
Overall Status: Completed

Phase

2/3

Condition

Sjogren's Syndrome

Eyelid Inflammation

Dry Eyes

Treatment

N/A

Clinical Study ID

NCT04670263
SZMC-TFI-2019
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 ineach 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 ofclinically active dry eye disease in either eye, by at least one of:
  6. Corneal fluorescein staining - at least severe in one section or moderate at two
  7. TBUT =< 10 sec
  8. Schirmer wetting of less than 10 mm in 5 min (with anesthesia).
  9. Control will be enrolled if they manifest NO symptoms (OSDI <13) and NO signs ofclinically active dry eye disease in either eye, by meeting all the followingcriteria's:
  10. Corneal fluorescein staining - negative
  11. TBUT > 10
  12. Schirmer wetting of more than 10 mm in 5 min (with anesthesia).
  13. A negative urine pregnancy test if female of childbearing potential.

Exclusion

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 preauricularlymphadenopathy.
  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 orduring the study period.
  5. Concomitant use of any prohibited medication (antihistamines, corticosteroids, allocular 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 chronicophthalmologic disorder other than allergic conjunctivitis.
  7. History of any ocular surgical procedure within 3 months prior to Visit 1.

Study Design

Total Participants: 70
Study Start date:
March 08, 2020
Estimated Completion Date:
September 23, 2021

Study 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.

Connect with a study center

  • Shaare Zedek Medical Center

    Jerusalem,
    Israel

    Site Not Available

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