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Corneal Tear Film Imaging of the Cornea Before and After Restasis Therapy

Primary Purpose

Dry Eye Syndrome, Tear Film Insufficiency

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tear Film Imager
Restasis
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dry Eye Syndrome focused on measuring Dry Eye Disease, Tear Film Imager, tear film, Cyclosporine, dry eye syndrome, keratoconjunctivitis sicca

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Non-pregnant adults, excluding individuals with legal misjudgement, with moderate-severe Dry Eye Syndrome (DES).

Moderate-severe DES will be defined by the following criteria:

  1. Schirmer test without anesthesia < 7 mm / 5 seconds AND
  2. One or more of the following (a-c):

    1. OSDI score >20
    2. Positive fluorescein staining (staining degree 1 in one of the eyes, where 0=no staining, 3=very significant staining)
    3. Tear Break-Up Time (TBUT) <= 8 seconds in one of the eyes.

Exclusion Criteria:

  1. Disagreement to participate in the trial
  2. Stevens-Johnson syndrome
  3. Post-burn ocular injury
  4. Chronic ocular diseases other that DES requiring topical treatment
  5. Ocular herpes simplex disease
  6. Persistent ocular inflammation or infection
  7. Active blepharitis or blepharitis defined more severe than mild
  8. Intraocular procedure less than 3 months prior to participation in the trial
  9. Punctal plugs in one of the eyes
  10. Subepithelial corneal scars
  11. Neurotrophic cornea
  12. Contact lens use in the 3 months prior to participation in the trial
  13. Current topical treatment with Cyclosporine A
  14. Previous refractive surgery
  15. Keratoconus patients

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    DES treated patients

    Arm Description

    This single group of patients is imaged by the Tear Film Imager (TFI) device before and after treatment with Restasis, the treatment indicated for their condition.

    Outcomes

    Primary Outcome Measures

    Tear Film changes
    The tear film layers are imaged by the TFI before and after Restasis therapy. We will compare the differences in the tear film image in eyes before after therapy and see if there are significant differences between them.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 11, 2018
    Last Updated
    January 11, 2018
    Sponsor
    Meir Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03403023
    Brief Title
    Corneal Tear Film Imaging of the Cornea Before and After Restasis Therapy
    Official Title
    Corneal Tear Film Imaging of the Cornea Before and After Restasis Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 30, 2018 (Anticipated)
    Primary Completion Date
    May 30, 2018 (Anticipated)
    Study Completion Date
    December 30, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Meir Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Dry Eye Syndrome (DES) is a disease affects the production and stability of the tear film, leading to vision disturbances and a major decrease in quality of life. The most recommended treatment for moderate-severe DES today which failed conservative therapy with lubricating eye drops is topical Cyclosporine 0.05% (Restasis®). The Tear Film Imager (TFI) is a novel imaging modality designed for visualization of the individual tear film layers up to a resolution of 0.1 micrometers, a property not enabled by any other imaging modality for this indication to date. In this study we wish to assess the effects of topical Cyclosporine 0.05% on the tear film using the TFI. In our previous study we found this modality yields high resolution images of the tear film, yielding significant differences between healthy and diseased (DES) eyes. We believe the TFI will improve quality of assessment and follow-up of DES patients, allowing more effective diagnosis and treatment of this disease in the future.
    Detailed Description
    Dry Eye Syndrome (DES) is a common eye disease that damages corneal eye surface in approximately 30% of patients who turn to treatment by Ophthalmologists. These diseases derive from changes in the quantity and quality of the tear film. Lack of timely treatment can lead to corneal surface damage, pain, infection and vision disturbances. However, effective treatment of the disease can lead to a significant improvement in patients' quality of life and improvement in visual acuity. Conventional treatment modalities focus mainly on lubricating eye drops, but these do not treat the pathophysiologic cause which is the inflammatory process evolving on the ocular surface. Topical Cyclosporine 0.05% (Restasis®) is an anti-inflammatory drug which is the most recommended treatment option for patients with moderate-severe DES who failed conservative treatment. It has been proven to be an effective and safe treatment modality for DES patients, improving tear production, tear film stabilization and slowing disease progression. The primary modalities for diagnosis and follow-up of DES patients today are manual and require clinician skill and experience. Moreover, current diagnosis modalities are subjective, examiner-based and are not easily reproducible. This raises the need for new diagnosis and follow-up modalities with higher resolution, precision and reproducibility qualities to allow more effective diagnosis and assessment of disease severity and well as assessment of disease progression over time. AdOM - Advanced Optical Methods produced a Tear Film Imager, a modality based on a standard camera, using white light to image the tear film up to a resolution of 0.1 micrometers. This allows imaging of the individual tear film layers, a property currently not enabled by advanced OCT imaging modalities in use today (yielding a maximum resolution of 2.5 micrometers, thus now allowing imaging of individual tear film layers). In addition, this modality functions using full field imaging rather than raster scanned imaging, thus allowing a wide, full image of the scanned area. The purpose of the current study is to assess the usage of the TFI in the follow-up of DES patients with moderate-severe disease treated with topical Cyclosporine 0.05%. In our previous study we found that the TFI yields high resolution tear film images, presenting significant differences between healthy and DES eyes. In this study we wish to examine the effects of topical Cyclosporine 0.05% on the tear film and assess the tear film before and after treatment. We believe this can help us better understand the effects of both the disease and the treatment on the tear film, thus allowing more effective diagnosis and treatment for future DES patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dry Eye Syndrome, Tear Film Insufficiency
    Keywords
    Dry Eye Disease, Tear Film Imager, tear film, Cyclosporine, dry eye syndrome, keratoconjunctivitis sicca

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    A single group of patients with DES is imaged before and after treatment with Restasis, a medication which is already FDA approved for this indication.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    DES treated patients
    Arm Type
    Experimental
    Arm Description
    This single group of patients is imaged by the Tear Film Imager (TFI) device before and after treatment with Restasis, the treatment indicated for their condition.
    Intervention Type
    Device
    Intervention Name(s)
    Tear Film Imager
    Other Intervention Name(s)
    TFI
    Intervention Description
    The TFI is an imaging device based on standard camera that uses white light to image the tear film in an ultra high resolution. DES patients in this study will be imaged before and 3 months after initiation of treatment with Restasis (the treatment indicated for their condition).
    Intervention Type
    Drug
    Intervention Name(s)
    Restasis
    Other Intervention Name(s)
    Ophthalmic Cyclosporine A 0.05%
    Intervention Description
    Restasis therapy is given to all of the patients as indicated for moderate-severe DES. TFI imaging is performed before and 3 months after initiation of therapy.
    Primary Outcome Measure Information:
    Title
    Tear Film changes
    Description
    The tear film layers are imaged by the TFI before and after Restasis therapy. We will compare the differences in the tear film image in eyes before after therapy and see if there are significant differences between them.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Non-pregnant adults, excluding individuals with legal misjudgement, with moderate-severe Dry Eye Syndrome (DES). Moderate-severe DES will be defined by the following criteria: Schirmer test without anesthesia < 7 mm / 5 seconds AND One or more of the following (a-c): OSDI score >20 Positive fluorescein staining (staining degree 1 in one of the eyes, where 0=no staining, 3=very significant staining) Tear Break-Up Time (TBUT) <= 8 seconds in one of the eyes. Exclusion Criteria: Disagreement to participate in the trial Stevens-Johnson syndrome Post-burn ocular injury Chronic ocular diseases other that DES requiring topical treatment Ocular herpes simplex disease Persistent ocular inflammation or infection Active blepharitis or blepharitis defined more severe than mild Intraocular procedure less than 3 months prior to participation in the trial Punctal plugs in one of the eyes Subepithelial corneal scars Neurotrophic cornea Contact lens use in the 3 months prior to participation in the trial Current topical treatment with Cyclosporine A Previous refractive surgery Keratoconus patients
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yael Yohai Patael, M.D.
    Phone
    +972544914544
    Email
    yael.yohai@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fani Segev, M.D.
    Phone
    +972526995044
    Email
    fsegev@netvision.net.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fani Segev, M.D.
    Organizational Affiliation
    Ophthalmology department, MeirMC, Israel
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    16004673
    Citation
    Stonecipher K, Perry HD, Gross RH, Kerney DL. The impact of topical cyclosporine A emulsion 0.05% on the outcomes of patients with keratoconjunctivitis sicca. Curr Med Res Opin. 2005 Jul;21(7):1057-63. doi: 10.1185/030079905X50615.
    Results Reference
    background
    PubMed Identifier
    17075627
    Citation
    Pflugfelder SC. Anti-inflammatory therapy of dry eye. Ocul Surf. 2003 Jan;1(1):31-6. doi: 10.1016/s1542-0124(12)70005-8.
    Results Reference
    background

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    Corneal Tear Film Imaging of the Cornea Before and After Restasis Therapy

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