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FID 123320 · 1 trial · 2 indications
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...
FID 123320 is an investigational small molecule being developed for the reduction of ocular redness and eye irritation. It is intended for use in pediatric and adult populations. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
FID 123320 is being developed by Alcon Inc., a company traded on the New York Stock Exchange under the ticker symbol ALC. Alcon is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for ocular redness.
FID 123320 is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies. The drug is being studied for the reduction of ocular redness and eye irritation in both pediatric and adult patients.
FID 123320 has one completed Phase 3 clinical trial registered under NCT06538662. This study investigated the drug for the reduction of ocular redness in pediatric and adult populations. The trial enrolled 283 participants in the United States and was randomized, double-blind, and placebo-controlled.
FID 123320 is not FDA approved. It is an investigational drug currently in Phase 3 clinical development. A completed Phase 3 trial (NCT06538662) evaluated its use for ocular redness, but regulatory approval has not been granted.