Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01338610 | ESBA105 in Patients With Severe Dry Eye | PHASE2 | COMPLETED | 334 | — | — | Jun 1, 2011 | Feb 1, 2012 | Apr 19, 2013 | 1 | United States |
An electronic Visual Analog Scale (eVAS) was used by the subject to assess ocular discomfort, both frequency and severity, at Day 0 (pre-treatment) and daily thereafter for 28 days. Assessments were entered into a LogPad® (handheld electronic device). The VAS frequency score ranged from 0 (rarely) to 100 (all the time), and the VAS severity score ranged from 0 (very mildly uncomfortable) to 100 (very severely uncomfortable). The Global Ocular Discomfort Score is a composite of the frequency and severity VAS scores (0-100).
| Arm | Type | Description |
|---|---|---|
| ESBA105 | EXPERIMENTAL | ESBA105 ophthalmic solution, 1 drop in each eye 3 times per day for 4 weeks |
| Vehicle | PLACEBO_COMPARATOR | ESBA105 vehicle, 1 drop in each eye 3 times per day for 4 weeks |
| Name | Type | Description |
|---|---|---|
| ESBA105 ophthalmic solution | BIOLOGICAL | - |
| ESBA105 vehicle | OTHER | Inactive ingredients used as Run-In and placebo comparator |
Inclusion Criteria: * Ongoing physician diagnosis of dry eye for at least 6 months. * Use of artificial tears, gels, lubricants, or re-wetting drops on a regular basis. * Experience persistent ocular discomfort. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Contact ...