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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06444529 | A Double-Masked Comparison of FID 123320 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness | PHASE3 | COMPLETED | 159 | — | — | Aug 21, 2024 | Jan 8, 2025 | Oct 23, 2025 | 5 | United States |
Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe). This endpoint is co-primary with the 10 hours post-instillation endpoint.
Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe). This endpoint is co-primary with the 15 minutes post-instillation endpoint.
| Arm | Type | Description |
|---|---|---|
| Apraclonidine Hydrochloride Ophthalmic Solution | EXPERIMENTAL | One drop in each eye on Day 1, followed by 2 drops in each eye on Day 2 onward for approximately 8 weeks |
| Vehicle | PLACEBO_COMPARATOR | One drop in each eye on Day 1, followed by 2 drops in each eye on Day 2 onward for approximately 8 weeks |
| Name | Type | Description |
|---|---|---|
| Apraclonidine Hydrochloride Ophthalmic Solution | DRUG | Investigational ophthalmic solution applied topically to the eye with a dropper bottle |
| Vehicle | DRUG | Vehicle (inactive ingredients) applied topically to the eye with a dropper bottle |
Key Inclusion Criteria: * Capable of giving signed informed consent; * Willing and able to follow all instructions and attend all study visits; * Able to self-administer eye drops- in the opinion of the investigator; * History of redness relief drop use within the last 6 months, or a desire to use ...