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This study will evaluate the effect of TRYPTYR in patients with Sjögren's syndrome-related dry eye disease. The goal is to determine whether TRYPTYR can improve symptoms and signs of dry eye in this specific patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study eye | Experimental | The study eye is the eye with the lower pre-drop unanesthetized Schirmer score performed at the baseline visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRYPTYR (Acoltremon ophthalmic solution 0.003%) | Drug | Drop to be instilled before and after endpoint measurement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from pre-instillation to 3 minutes post-TRYPTYR instillation in study eye unanesthetized Schirmer's test at Visit 1 (baseline) | Unanesthetized Schirmer's test will be measured prior to instillation and then again 3 minutes after instillation of the TRYPTYR. The difference between the 2 measurements will be compared. | 3 minutes |
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Inclusion Criteria:
Subjects must fulfill the following conditions to qualify for enrollment into the trial
Exclusion Criteria:
Subjects with any of the following conditions on the eligibility exam may NOT be enrolled into the trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gina Thomas | Contact | 9412634784 | gina.thomas@useye.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center For Sight | Recruiting | Venice | Florida | 34285 | United States |
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