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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05814757 | OTX-DED for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED) | PHASE2 | COMPLETED | 100 | — | — | May 11, 2023 | May 22, 2024 | Jul 10, 2024 | 1 | United States |
Visual Analogue Scale (0 mm - no discomfort to 100mm - maximal (the most) discomfort)
| Arm | Type | Description |
|---|---|---|
| OTX-DED 0.3mg | EXPERIMENTAL | - |
| Controlled Insertion utilizing Collagen Punctal Plug | EXPERIMENTAL | - |
| Collagen Punctal Plug (Full Insertion) | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| OTX-DED | DRUG | 0.3mg dexamethasone ophthalmic insert |
| Controlled Insertion | DRUG | Collagen Punctal Plug 0.2mm (Controlled Insertion) |
| Collagen Punctal Plug | DRUG | Collagen Punctal Plug 0.2mm (Full Insertion) |
Inclusion Criteria: * VAS eye dryness severity score ≥ 35 and ≤ 90 at screening. * Investigator assessment of bulbar conjunctival hyperemia grade ≥ 2 (CCLRU; 0 - 4 scale). * Unanesthetized Schirmer of \> 0 and ≤ 10 mm. * Must not have used Artificial Tears during the Screening period. * IOP in both...