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Also known as AL-4943A ophthalmic solution
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 ophthalmic solution being developed for the treatment of allergic conjunctivitis. It is a small molecule formulated for topical eye administration and has been studied in Phase 3 clinical trials in patients with this condition.
AL-4943A is being developed by Alcon Inc., which trades on the New York Stock Exchange under the ticker ALC. Alcon is an eye care company, and AL-4943A is part of its ophthalmology pipeline.
AL-4943A is in Phase 3 clinical development. Three Phase 3 trials have been completed, and no trials are currently active. The program has enrolled a total of 1,817 participants across these completed studies.
AL-4943A has been evaluated in three completed Phase 3 trials: NCT01743027, which enrolled 902 patients with allergic conjunctivitis; NCT01698814, a six-week safety study enrolling 518 participants; and NCT01479374, which enrolled 397 patients using the conjunctival allergen challenge model.
Yes. AL-4943A ophthalmic solution and AL-4943A Ophthalmic Solution are alternative names for the same investigational product, AL-4943A. All refer to the topical eye drop formulation being developed by Alcon Inc. for allergic conjunctivitis.
The AL-4943A Phase 3 trials were randomized, double-blind, and placebo-controlled. Two studies enrolled adults aged 18 years and older with allergic conjunctivitis, while the six-week safety study NCT01698814 included participants from 2 years of age, including healthy volunteers.