Not provided
Not provided
Not provided
Not provided
Not provided
COVID restrictions
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Novartis | INDUSTRY |
Not provided
Not provided
Not provided
The purpose of this study is to assess the duration of time (in weeks) for improvement in objective dry eye markers for people who are placed on lifitegrast 0.5% (Xiidra®), an FDA-approved therapy for dry eyes.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifitegrast 5% Ophthalmic Solution | Experimental | Participants will received lifitegrast 5% ophthalmic solution twice a day in each eye for approximately 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifitegrast 5% Ophthalmic Solution | Drug | Participants will received lifitegrast 5% ophthalmic solution twice a day in each eye for approximately 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change in proportion of subjects demonstrating improved tear film osmolarity | Improved tear film osmolarity will be defined as an osmolarity reading of less than or equal to 308 mOsm/L or an inter-eye difference osmolarity reading of less than or equal to 8 mOsm/L. | Baseline, Weeks 1, 2, 3 and 4 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects demonstrating normal Matrix Metallopeptidase 9 (MMP9). | Normal MMP9 is determined by 2 blinded investigators who each independently read the test result as negative and who are in agreement. | Week 4 |
| The proportion of subjects demonstrating normal Tear Break-Up Time (TBUT). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christopher Starr, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Ophthalmology | New York | New York | 10021 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C575157 | lifitegrast |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Greater than 10 seconds is normal, 5 to 10 seconds is marginal, and less than 5 seconds is low. |
| Week 4 |
| The proportion of subjects demonstrating normal corneal fluorescein staining. | Corneal staining will be assessed using the National Eye Institute Scale for corneal staining. | Week 4 |
| The proportion of subjects demonstrating improvement in their symptoms as measured by the modified SANDE Questionnaire. | A modified SANDE Questionnaire uses a visual analogue scale at the Baseline Visit to measure the frequency and severity of subject's dry eyes symptoms. Subsequent visit Questionnaires will use a visual analogue scale to measure the change in symptoms compare to the results of the prior visit. | Week 4 |
| D020228 |
| Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |