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
Not provided
Not provided
Not provided
The objective of this study is to evaluate the efficacy of Rohto Dry-Aid® in comparison to Systane® Ultra on visual function and tear film stability in patients diagnosed with Dry Eye.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental |
| |
| Active Comparator | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rohto Dry-Aid® | Drug |
| ||
| Systane® Ultra |
| Measure | Description | Time Frame |
|---|---|---|
| Dry Eye Staining | Dry eye syndrome corneal and conjunctival staining assessment | 28 days |
| Dry Eye Symptom Questionnaire | Symptom assessment questionnaire | 28 days |
| Tear Film Break Up Time | Tear Film Break Up Time after instillation of fluorescein dye | 28 days |
| Visual Function Assessment | Reading Test | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Drop Comfort Assessment | The comfort of the eye drop will be performed to assess changes from baseline | Day 1 |
| Visual Acuity | Visual Acuity will be measured using the EDTRS chart to assess changes from baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gail L Torkildsen, M.D. | Andover Eye Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andover Eye Associates | Andover | Massachusetts | 01810 | 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
Not provided
Not provided
Not provided
Not provided
|
| 28 Days |
| Slit-Lamp Biomicroscopy | Slit lamp biomicroscopy exams will be performed to assess any changes from baseline | 28 Days |
| Adverse Event | Adverse Event queries | 28 Days |