Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bausch & Lomb Incorporated | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
To evaluate glaucoma patients' response to treatment with Xiidra, an FDA-approved drug for ocular surface discomfort, which will be prescribed as standard of care treatment.
To assess glaucoma patients' response to treatment with Xiidra (Lifitegrast ophthalmic solution) 5% for ocular surface discomfort caused, in part, by topical glaucoma antihypertensive medications.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Xiidra (Lifitegrast ophthalmic solution) 5% applied to both eye (OU) for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xiidra (Lifitegrast ophthalmic solution) 5% | Drug | FDA approved lifitegrast opthalmic solution eye drop |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to week 12 in corneal fluorescein staining score | Change in corneal fluorescein staining score | From baseline to Week 12 |
| Change from baseline to week 12 in eye dryness score (EDS) | Change in eye dryness score (EDS) | From baseline to Week 12 |
| Change from baseline to week 12 in ocular surface disease index (OSDI) questionnaire score | Change in ocular surface disease index (OSDI) questionnaire score | From baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change at intermediate week visits in corneal fluorescein staining score | Change in corneal fluorescein staining score | From baseline and at weeks 2, 6, and 12 |
| Change at intermediate week visits in eye dryness score (EDS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Glaucoma patients suffering from ocular surface discomfort
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benjamin B Bert, MD | Contact | 626-817-4701 | BBert@mednet.ucla.edu | |
| Mayra Raygoza | Contact | 16268174747 | 19093 | Mraygoza@mednet.ucla.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Doheny Eye Center UCLA | Recruiting | Fountain Valley | California | 92708 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 4, 2020 | Apr 8, 2020 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C575157 | lifitegrast |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Change in eye dryness score (EDS)
| From baseline and at weeks 2, 6, and 12 |
| Change at intermediate week visits in ocular surface disease index (OSDI) questionnaire score | Change in ocular surface disease index (OSDI) questionnaire score | From baseline and at weeks 2, 6, and 12 |
| Changes in the subcategories of ocular surface disease index (OSDI) questionnaire score at intermediate week visits | Change in subcategory scores of ocular surface disease index (OSDI) questionnaire | From baseline and at weeks 2, 6, and 12 |