Clinical trial NCT03403023: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye Syndrome
Tear Film Insufficiency
Keywords: Dry Eye Disease
Tear Film Imager
tear film
Cyclosporine
dry eye syndrome
keratoconjunctivitis sicca
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DIAGNOSTIC

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.

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:

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

Primary outcomes:
measure: Tear Film changes
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ophthalmology department, MeirMC, Israel
name: Fani Segev, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.