Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ketotifen, 0.025% · 1 trial · 1 indication
Ocular discomfort as measured by Visual Analog Scale (VAS) with 0=none to 50=severe, was assessed by subjects every 30 seconds between 0 to 180 seconds after drop instillation (at 0, 30, 60, 90, 120, 150, and 180 seconds). Peak discomfort (maximum observed VAS discomfort score over the 3-minute period) for each subject in each period was analyzed.
| Arm | Type | Description |
|---|---|---|
| Olopatadine, 0.7% | EXPERIMENTAL | Olopatadine hydrochloride ophthalmic solution, 0.7%, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic vehicle and ketotifen fumarate ophthalmic solution, 0.025%, Periods 2 and 3, as randomized |
| Vehicle | PLACEBO_COMPARATOR | Olopatadine hydrochloride ophthalmic solution vehicle, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic solution, 0.7% and ketotifen fumarate ophthalmic solution, 0.025%, Periods 2 and 3, as randomized |
| Zaditor | ACTIVE_COMPARATOR | Ketotifen fumarate ophthalmic solution, 0.025%, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic solution, 0.7% and olopatadine hydrochloride ophthalmic solution vehicle, Periods 2 and 3, as randomized |
| Name | Type | Description |
|---|---|---|
| Olopatadine hydrochloride ophthalmic solution, 0.7% | DRUG | Treatment A |
| Olopatadine hydrochloride ophthalmic solution vehicle | DRUG | Treatment B, inactive ingredients used as placebo |
| Ketotifen fumarate ophthalmic solution, 0.025% | DRUG | Treatment C |
Inclusion Criteria: * Able to be dosed in both eyes, to follow instructions, and willing and able to attend required study visits. * Negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period. * Other protocol-defined inclusion crite...
Ketotifen 0.025% is an ophthalmic solution used for allergic conjunctivitis, a condition characterized by eye redness, itching, and swelling due to an allergic reaction. It is being developed as a small molecule treatment administered directly to the eye to address these symptoms.
Alcon Inc. (NYSE: ALC) is developing Ketotifen 0.025% for allergic conjunctivitis. The company is conducting clinical trials to evaluate the safety and comfort of this ophthalmic solution.
Ketotifen 0.025% is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed to assess its safety and tolerability in healthy volunteers.
Ketotifen 0.025% has one completed clinical trial, NCT01326858, titled 'Safety and Comfort of AL-4943A Ophthalmic Solution.' This Phase 1, randomized, double-blind, placebo-controlled study enrolled 50 participants aged 18 years and older to evaluate the solution's safety and comfort in allergic conjunctivitis.
Yes, Ketotifen 0.025% is also known as AL-4943A. In clinical trials, the drug is referred to by this alternative name, as seen in the study title 'Safety and Comfort of AL-4943A Ophthalmic Solution.'