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Keratoconjunctivitis sicca, also known as dry eye syndrome, is one of the most common ophthalmological diseases and is treated with tear substitutes to moisten the surface of the eye and, in more severe cases of this disease, with local anti-inflammatory therapy with corticosteroids or ciclosporin A. In patients with rheumatological diseases, such as Sjögren's syndrome, dry eye syndrome of severe extent occurs particularly frequently, which is why topical anti-inflammatory therapy is often necessary in these patients.
Aim of this study is to evaluate the treatment of severe dry eye syndrome with topical cyclosporin eyedrops with and without topical corticosteroids at the beginning of the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| right eye: Ciclosporin, left eye: Ciclosporin + Hydrocortisone | Experimental | Patients receive treatment with Ciclosporin eyedrops for the right eye and Ciclosporin eyedrops + Hydrocortisone eyedrops for the left eye |
|
| left eye: Ciclosporin, right eye: Ciclosporin + Hydrocortisone | Experimental | Patients receive treatment with Ciclosporin eyedrops for the left eye and Ciclosporin eyedrops + Hydrocortisone eyedrops for the right eye |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclosporin | Drug | Cyclosporin eyedrops |
|
| Measure | Description | Time Frame |
|---|---|---|
| tearfilm breakup time | tearfilm breakup time measured with Fluorescein | 6 months |
| corneal fluorescein staining | corneal fluorescein staining staged with Oxford grading scale, ranging from 0 (no staining) to 5 (maximal staining) | 6 months |
| corneal optical aberrations | corneal optical aberrations measured with iTrace aberrometry | 6 months |
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Inclusion Criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Augenabteilung - Klinik Hietzing | Vienna | 1130 | Austria |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| D006854 | Hydrocortisone |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Hydrocortisone | Drug | Hydrocortisone eyedrops |
|
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |