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This study aims to evaluate the performance of biomarkers and their responsiveness to standard-of-care treatments (Vevye® or Xiidra®), in participants with dry eye disease (DED) compared to healthy volunteers (control participants).
This study aims to characterize longitudinal changes in signs, symptoms, molecular, and imaging markers of the ocular surface to investigate pathological mechanisms and biomarkers (BMs) of DED after treatment with either of two commercially approved therapeutics (Vevye® [cyclosporine ophthalmic solution], Xiidra® [liftegrast ophthalmic solution]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vevye® | Experimental | Participants with evaporative dry eye (EDE), aqueous deficient dry eye (ADDE) and mixed dry eye will receive Vevye®, 1 milligrams per milliliter (mg/mL) as one drop into the affected eye(s), twice daily (BID) via topical ocular instillation for 12 weeks. |
|
| Xiidra® | Experimental | Participants with EDE, ADDE, and mixed dry eye will receive Xiidra®, 50 mg/mL as one drop into the affected eye(s), BID via topical ocular instillation for 12 weeks. |
|
| Healthy Cohort | No Intervention | Healthy volunteers will be enrolled as a control group and will not receive any treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vevye® | Drug | Participants will receive Vevye® (0.1% cyclosporine ophthalmic solution) as per the schedule described in the treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Corneal Staining as Measured by Sodium Fluorescein | Up to Week 12 |
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Inclusion Criteria:
A. Inclusion Criteria for Participants with DED:
B. Inclusion Criteria for Healthy Volunteers:
- The participant does not have overt clinical signs of DED in either eye
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Research Foundation | Newport Beach | California | 92663 | United States | ||
| Butchertown Clinical Trials |
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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This is a partially masked study where health care professionals conducting the ocular assessments will be masked to treatment assignment but not to study eye assignment. However, other site personnel and participants will be unmasked.
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| Xiidra® | Drug | Participants will receive Xiidra® (5% lifitegrast ophthalmic solution) as per the schedule described in the treatment arm. |
|
|
| Louisville |
| Kentucky |
| 40206 |
| United States |
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States |
| Oculus Research | Garner | North Carolina | 27529 | United States |
| CORE Inc. | Shelby | North Carolina | 28150 | United States |
| Advancing Vision Research, LLC | Goodlettsville | Tennessee | 37072 | United States |
| Total Eyecare, P.A. | Memphis | Tennessee | 38119 | United States |
| Piedmont Eye Center | Lynchburg | Virginia | 24502-4271 | United States |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C575157 | lifitegrast |
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