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
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
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
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
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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