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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05878067 | A Study to Assess Symptom Relief and Product Tolerability of ABBV-444 Drops in Adult Participants | PHASE3 | COMPLETED | 40 | — | — | Jun 27, 2023 | Oct 6, 2023 | Oct 15, 2024 | 1 | United States |
The OSDI is a 12-question survey for participants to document their dry eye disease symptoms. The OSDI consists of a 5-point scale ranging from 0 (none of the time) to 4 (all of the time), with higher scores representing greater disability. The scores from the 12 questions are totaled and converted to an overall score ranging from 0 (no disability) to 100 (complete disability). A negative number change from baseline represents an improvement.
| Arm | Type | Description |
|---|---|---|
| ABBV-444 | EXPERIMENTAL | Participants will administer 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days. |
| Name | Type | Description |
|---|---|---|
| ABBV-444 | DRUG | Lubricant Eye drops |
Inclusion Criteria: * Had used artificial tears for dry eyes within the past year * OSDI score of ≥ 18 and ≤ 65 (based upon a 0 to 100 scale) at Screening and Baseline Visits Three consecutive tear breakup time (TBUT) tests ≤ 10 seconds in at least 1 eye at Day -7 (screening) * Grade 1 to 4 (modifi...