Dry Eye SyndromeNCT03403023
Corneal Tear Film Imaging of the Cornea Before and After Restasis Therapy
A study testing Tear Film Imager and Restasis in people with Dry Eye Syndrome and Tear Film Insufficiency, run by Meir Medical Center.
Trial 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%… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome, Tear Film Insufficiency
- What is being tested?
- Tear Film Imager and Restasis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2018to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Dry Eye Syndrome, Tear Film Insufficiency
- Being tested
- Tear Film Imager, Restasis
- Keywords
- Dry Eye Disease, Tear Film Imager, tear film, Cyclosporine, dry eye syndrome, keratoconjunctivitis sicca
- Medical subject headings
- Dry Eye Syndromes, Xerophthalmia, Keratoconjunctivitis Sicca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tear Film ImagerDevice
Also called TFI
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).
RestasisDrug
Also called Ophthalmic Cyclosporine A 0.05%
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.
| Study group | Role | What they receive |
|---|---|---|
| DES treated patients | Experimental | 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. Receives: Device: Tear Film Imager; Drug: Restasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start30 Jan 2018 (estimated)
- Primary completion30 May 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, segev fani, Meir Medical Center
- Investigators
- Fani Segev, M.D., Principal investigator, Ophthalmology department, MeirMC, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403023
- Sponsor's protocol ID
- 0178-16-MMC
- Status last verified
- Oct 2017
- First submitted
- 11 Jan 2018
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16004673Pflugfelder SC. Anti-inflammatory therapy of dry eye. Ocul Surf. 2003 Jan;1(1):31-6. doi: 10.1016/s1542-0124(12)70005-8.
PubMed 17075627
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Tear Film Imaging of the Cornea Before and After Restasis Therapy
- ClinicalTrials.gov ID
- NCT03403023
- Acronym / sponsor ID
- 0178-16-MMC
- Conditions
- Dry Eye Syndrome, Tear Film Insufficiency
- Keywords
- Dry Eye Disease, Tear Film Imager, tear film, Cyclosporine, dry eye syndrome, keratoconjunctivitis sicca
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 30 Jan 2018 (estimated)
- Primary completion
- 30 May 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 18 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| DES treated patients | Experimental | Device: Tear Film Imager, Drug: RestasisThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Non-pregnant adults, excluding individuals with legal misjudgement, with moderate-severe Dry Eye Syndrome (DES).
- Schirmer test without anesthesia < 7 mm / 5 seconds AND
- One or more of the following (a-c):
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tear Film ImagerAlso: TFIThe 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). | Device | DES treated patients |
| RestasisAlso: Ophthalmic Cyclosporine A 0.05%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. | Drug | DES treated patients |
Primary outcome
Tear Film changes
Time frame: 3 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Background: PubMed 16004673Stonecipher 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.
- Background: PubMed 17075627Pflugfelder SC. Anti-inflammatory therapy of dry eye. Ocul Surf. 2003 Jan;1(1):31-6. doi: 10.1016/s1542-0124(12)70005-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fani Segev, M.D. principal investigator
Ophthalmology department, MeirMC, Israel
Questions about this trial
What is this clinical trial studying?
A study testing Tear Film Imager and Restasis in people with Dry Eye Syndrome and Tear Film Insufficiency, run by Meir Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yael Yohai Patael, M.D. (+972544914544, yael.yohai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear Film changes (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03403023, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.