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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | December 30, 2018 |
Est. primary completion date | May 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Meir Medical Center |
Pflugfelder SC. Anti-inflammatory therapy of dry eye. Ocul Surf. 2003 Jan;1(1):31-6. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 3 months |
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