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| Name | Class |
|---|---|
| Sun Pharmaceutical Industries Limited | INDUSTRY |
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The primary objective of this study is to show that CEQUA (cyclosporine 0.09% ophthalmic solution) improves symptoms of dry eye disease in a population of patients with Sjogren's Syndrome diagnosis.
After being informed about the study and potential risks, all participants giving informed consent will have an eye exam and will be asked about their medical history to determine eligibility for the study. Eligible participants will continue to the second visit the same day or up to 10 days later. During the second visit participants will answer questionnaires about their eyes and have their vision, eyes, and tears examined. All participants will be given CEQUA to use over the duration of the study. The same procedures will be repeated every four weeks for 3 months total.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclosporine | Experimental | Participants receive Cyclosporine 0.09% Ophthalmic Solution (Cequa), 1 drop, each eye, twice a day for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclosporine 0.09% Ophthalmic Solution | Drug | one drop each eye twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in total corneal staining | Expanded NEI corneal staining scale ranging from 0 to 15 | Baseline and week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in total conjunctival staining | Expanded NEI conjunctival staining scale ranging from 0 to 20 | Baseline and week 12 |
| Mean change from baseline in the score of dry eye questionnaires |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Rocco Robilotto, OD, PhD | Center for Ophthalmic and Vision Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Ophthalmic and Vision Recearch | Manhattan | New York | 10022 | United States |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D012859 | Sjogren's Syndrome |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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Dry eye questionnaire score ranging from 0 to 28
| Baseline and week 12 |
| D007592 |
| Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |