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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06538662 | An Investigation of FID 123320 for the Reduction of Ocular Redness in Pediatric and Adult Populations | PHASE3 | COMPLETED | 283 | — | — | Oct 7, 2024 | Apr 3, 2025 | Jan 22, 2026 | 10 | United States |
Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale. This is a co-primary endpoint.
Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale. This is a co-primary endpoint.
Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale.
| Arm | Type | Description |
|---|---|---|
| FID 123320 Ophthalmic Solution - Adult Cohort | EXPERIMENTAL | 1 drop instilled in each eye at Visit 2 (Day 1), followed by one drop instilled in each eye twice a day (approximately 12 hours apart) Day 2 up to Visit 5 (Day 56), followed by 1 drop instilled in each eye at Visit 5 (Day 56). |
| Vehicle - Adult Cohort | PLACEBO_COMPARATOR | 1 drop instilled in each eye at Visit 2 (Day 1), followed by one drop instilled in each eye twice a day (approximately 12 hours apart) Day 2 up to Visit 5 (Day 56), followed by 1 drop instilled in each eye at Visit 5 (Day 56). |
| FID 123320 Ophthalmic Solution - Pediatric Cohort | EXPERIMENTAL | 1 drop instilled in each eye at Visit 2 (Day 1), followed by one drop instilled in each eye twice a day (approximately 12 hours apart) Day 2 up to Visit 5 (Day 56), followed by 1 drop instilled in each eye at Visit 5 (Day 56). |
| Vehicle - Pediatric Cohort | PLACEBO_COMPARATOR | 1 drop instilled in each eye at Visit 2 (Day 1), followed by one drop instilled in each eye twice a day (approximately 12 hours apart) Day 2 up to Visit 5 (Day 56), followed by 1 drop instilled in each eye at Visit 5 (Day 56). |
| Name | Type | Description |
|---|---|---|
| FID 123320 Ophthalmic Solution | DRUG | Investigational sterile aqueous solution |
| Vehicle | DRUG | FID 123320 Ophthalmic Solution inactive ingredients |
Key Inclusion Criteria - Adult Cohort: * 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; * Have a history of vasoconstrictor (redness relief drop) use within...