Dry Eye Syndrome Clinical Trial
Official title:
Corneal Tear Film Imaging of the Cornea Before and After Restasis Therapy
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02597803 -
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1
|
Phase 2/Phase 3 | |
| Completed |
NCT02522312 -
A Retrospective Analysis of Restasis® Benefits in Dry Eye Contact Lens Patients
|
N/A | |
| Completed |
NCT01863368 -
Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining
|
N/A | |
| Completed |
NCT01753752 -
Evaluation of the Corneal Residence Time of Chitosan-N-acetylcysteine Eye Drops in Patients With Dry Eye Syndrome After Single and Multiple Instillation
|
Phase 2 | |
| Completed |
NCT01753687 -
Correlation of Different Signs for Assessment of Dry Eye Syndrome
|
N/A | |
| Completed |
NCT01198782 -
Evaluating Safety and Efficacy of FID 112903 Post Discontinuation of Long-term Use of RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%
|
Phase 4 | |
| Completed |
NCT01212471 -
A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease
|
Phase 3 | |
| Completed |
NCT01162954 -
Phase I Study to Evaluate the Tolerability of Eye Drop DA-6034 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT00535054 -
Study to Assess the Safety and Patients' Satisfaction of Tears Again* in the Treatment of Dry Eye Symptoms
|
N/A | |
| Completed |
NCT00544713 -
Evaluate the Safety and Efficacy of a New Artificial Tear for Use After LASIK Surgery
|
N/A | |
| Completed |
NCT00344721 -
A Placebo Controlled Double Masked Clinical Assessment Study of Essential Fatty Acid Supplement and Its Effect on Patients With Apparent Aqueous Deficient Dry Eye Syndrome
|
N/A | |
| Completed |
NCT03830359 -
Efficacy, Safety of T2769 in Dry Eye Disease
|
N/A | |
| Completed |
NCT04139122 -
Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease
|
Phase 1/Phase 2 | |
| Completed |
NCT02758327 -
Evaluation of Tear Osmolarity Over Time With Sustained Use of Thera Tears Lubricating Drops
|
Phase 4 | |
| Completed |
NCT02066051 -
IPL and Meibomian Gland Expression to Treat Ocular Rosacea Ocular GVHD
|
N/A | |
| Completed |
NCT01970917 -
Effect of Olixia Pure® Eye Drops on Tear Film Thickness in Healthy Subjects
|
Phase 4 | |
| Completed |
NCT02092207 -
Phase 2 Study to Evaluation the Safety and Efficacy of Orally Administered KL7016 in Patients With Dry Eye Syndrome
|
Phase 2 | |
| Completed |
NCT01541891 -
Efficacy and Safety of PRO-148 Ophthalmic Solution Versus SYSTANE® in the Treatment of Patients With Dry Eye Syndrome
|
Phase 2 | |
| Completed |
NCT01252121 -
Residence Time Evaluation of Systane Ultra Lubricant Eye Drops vs. Hialid and Saline
|
N/A | |
| Completed |
NCT00765804 -
Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Dry Eye
|
Phase 2 |