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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02280473 | A Safety and Efficacy Study of Refresh Optive® Gel Drops in Patients With Dry Eye Disease | PHASE3 | COMPLETED | 188 | — | — | Nov 13, 2014 | Mar 16, 2015 | Apr 16, 2019 | 10 | United States |
The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.
| Arm | Type | Description |
|---|---|---|
| Refresh Optive® Gel Drops | EXPERIMENTAL | Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
| REFRESH LIQUIGEL® | ACTIVE_COMPARATOR | REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
| Name | Type | Description |
|---|---|---|
| Refresh Optive® Gel Drops | DRUG | Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
| REFRESH LIQUIGEL® | DRUG | REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
Inclusion Criteria: * Current use of an artificial tear product * Visual acuity of at least 20/32 (while wearing glasses, if necessary). Exclusion Criteria: * Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study * Cataract surgery, laser-assisted in si...