Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Brimonidine 0.025%/ Ketotifen 0.035% · 3 trials · 2 indications
TEAE is defined as any untoward medical occurrence or undesirable event(s) that begins or worsens following administration of the study drug, whether or not considered related to the treatment by the Investigator. A TEAE is considered serious if, in the view of the Investigator or Sponsor, it results in any of the following outcomes: death, a life-threatening TEAE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, an important medical event that jeopardized the participant and required medical intervention, or sight-threatening (possibly resulting in persistent or significant loss of vision)
Ocular itching score evaluated by the subject at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-4 scale, allowing half unit increments), with 4 is the worse outcome.
Ocular redness evaluated by the Investigator using slit lamp at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-4 scale, allowing half unit increments), with 4 being the worse outcome.
Ocular itching score (measured on a 0-4 unit scale, allowing half-unit increments; average score of the subject's two eyes) assessed by the subjects at 3 (±1), 5 (±1), and 7 (±1) minutes post-CAC.
Conjunctival redness score (measured on a 0-4unit scale, allowing half-unit increments; average score of the subject's two eyes) assessed by investigator at 7 (±1), 15 (±1), and 20 (±1) minutes post-CAC.
| Arm | Type | Description |
|---|---|---|
| Brimonidine tartrate 0.025%/ketotifen fumarate 0.035% combination ophthalmic solution | EXPERIMENTAL | - |
| Vehicle ophthalmic solution | ACTIVE_COMPARATOR | - |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | EXPERIMENTAL | Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution |
| Ketotifen fumarate ophthalmic solution 0.035% | EXPERIMENTAL | Ketotifen fumarate ophthalmic solution 0.035% |
| Brimonidine tartrate ophthalmic solution 0.025% | EXPERIMENTAL | Brimonidine tartrate ophthalmic solution 0.025% |
| Combination | EXPERIMENTAL | Brimonidine tartrate 0.025%/ketotifen fumarate 0.035% combination ophthalmic solution |
| Ketotifen fumarate | ACTIVE_COMPARATOR | ketotifen fumarate 0.035% ophthalmic solution |
| Brimonidine tartrate | ACTIVE_COMPARATOR | brimonidine tartrate 0.025% ophthalmic solution |
| Vehicle | PLACEBO_COMPARATOR | vehicle ophthalmic solution |
| Name | Type | Description |
|---|---|---|
| Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution (Combo) | DRUG | Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution (Combo) |
| Vehicle of brimonidine tartrate 0.025%/ketotifen fumarate 0.035% ophthalmic solution | DRUG | Vehicle of brimonidine tartrate 0.025%/ketotifen fumarate 0.035% ophthalmic solution |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | DRUG | Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution |
| Ketotifen fumarate ophthalmic solution 0.035% | DRUG | Ketotifen fumarate ophthalmic solution 0.035% |
| Brimonidine tartrate ophthalmic solution 0.025% | DRUG | Brimonidine tartrate ophthalmic solution 0.025% |
| Experimental: Vehicle ophthalmic solution | DRUG | Experimental: Vehicle ophthalmic solution |
| Brimonidine tartrate 0.025%/ketotifen fumarate 0.035% | DRUG | combination ophthalmic solution |
| Brimonidine Tartrate 0.025% | DRUG | ophthalmic Solution |
| Ketotifen Fumarate 0.035% | DRUG | ophthalmic Solution |
| Vehicle | DRUG | ophthalmic Solution |
Inclusion Criteria: 1. be at least 5 years of age at Screening Visit or Visit 1 (if Screening and Visit 1 are done on the same day), of either sex and any race (a government issued ID and/or birth certificate will be verified at the time ICF is signed); 2. provide written informed consent and sign ...