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The purpose of this study is to evaluate the efficacy of Optive versus Systane used concomitantly with topical cyclosporine for the treatment of dry eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Systane |
|
| 2 | Active Comparator | Optive |
|
| 3 | Placebo Comparator | Restasis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systane, Optive, Restasis | Drug | Systane 30ml (in the eye) instill one drop twice a day in morning and evening Optive 15ml (in the eye) instill one drop twice a day in morning and evening Restasis 0.4ml (in the eye) instill one drop twice a day in morning and evening more frequently if needed |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | 1 yr 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Dry eye symptoms | 1yr 3 months |
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Inclusion Criteria:
· Males or females > 18 years old
Exclusion Criteria:
· Prior unsuccessful use of topical cyclosporine (defined as patients taking it at least 3 months and saw no improvements)
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| Name | Affiliation | Role |
|---|---|---|
| Robert Schultze, MD | Slingerlands Medical Building | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Schultze | Slingerlands | New York | 12159 | United States |
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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 |
|---|---|
| D003524 | Cyclosporins |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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| D000602 |
| Amino Acids, Peptides, and Proteins |