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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01743027 | Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic Conjunctivitis | PHASE3 | COMPLETED | 902 | — | — | Jan 1, 2013 | Jul 1, 2013 | Aug 11, 2014 | - | — |
| NCT01698814 | A Six-Week Safety Study of an Investigational Ophthalmic Solution | PHASE3 | COMPLETED | 518 | — | — | Oct 1, 2012 | Jan 1, 2013 | Mar 27, 2014 | - | — |
| NCT01479374 | Efficacy and Safety of AL-4943A Ophthalmic Solution in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model | PHASE3 | COMPLETED | 397 | — | — | Jan 1, 2012 | Mar 1, 2012 | Jun 4, 2013 | - | — |
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...