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AL-4943A · 3 trials · 1 indication
A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.
A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.
An adverse event was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.
A treatment efficacy CAC was performed 16 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.
| Arm | Type | Description |
|---|---|---|
| AL-4943A | EXPERIMENTAL | AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 |
| PATADAY | ACTIVE_COMPARATOR | Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 |
| PATANOL | ACTIVE_COMPARATOR | Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 |
| Vehicle | PLACEBO_COMPARATOR | AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 |
| AL-4943A Vehicle | PLACEBO_COMPARATOR | AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks |
| Name | Type | Description |
|---|---|---|
| AL-4943A ophthalmic solution | DRUG | - |
| Olopatadine hydrochloride ophthalmic solution, 0.2% | DRUG | - |
| Olopatadine hydrochloride ophthalmic solution, 0.1% | DRUG | - |
| AL-4943A ophthalmic solution vehicle | DRUG | - |
| AL-4943A vehicle | DRUG | Inactive ingredients used as placebo |
Inclusion Criteria: * Able to be dosed in both eyes, able and willing to make the required study visits and to follow instructions. * Negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period. * Diagnostic skin test indicative of al...
AL-4943A is an investigational small molecule ophthalmic solution being developed for the treatment of allergic conjunctivitis. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
AL-4943A is being developed by Alcon Inc., a company traded on the New York Stock Exchange under the ticker symbol ALC. The drug is an investigational ophthalmic solution intended for patients with allergic conjunctivitis.
AL-4943A is in Phase 3 clinical development. It is an investigational drug and has not yet received regulatory approval. Three Phase 3 trials have been completed, with a total of 1,817 participants enrolled across the studies.
AL-4943A has completed three Phase 3 clinical trials: NCT01479374, which evaluated efficacy and safety using the conjunctival allergen challenge model in 397 patients; NCT01698814, a six-week safety study in 518 participants; and NCT01743027, an efficacy and safety study in 902 patients. All trials were randomized, double-blind, and placebo-controlled.
AL-4943A is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for allergic conjunctivitis. All three completed Phase 3 trials have finished, but the drug has not yet received marketing authorization from regulatory agencies.