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Ketotifen 4.0% Patch

Phase 2

Allergic Conjunctivitis | Small molecule | Ophthalmology |BrainsWay Ltd.|Last Updated: Aug 4, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment122

FDA Designations

No designations recorded

Clinical trial landscape

Ketotifen 4.0% Patch · 1 trial · 1 indication

Phase 2 1
NCT00836485Evaluation of the Safety and Efficacy of Ketotifen 4.0% Patch as Compared to Placebo Patch, Olopatadine 0.2% Ophthalmic Solution, and Artificial Tears in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic ConjunctivitisAllergic Conjunctivitis
COMPLETED122 Analytics
PHASE2COMPLETED
Evaluation of the Safety and Efficacy of Ketotifen 4.0% Patch as Compared to Placebo Patch, Olopatadine 0.2% Ophthalmic Solution, and Artificial Tears in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis
Allergic ConjunctivitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Ocular itching and bulbar conjunctival redness
Visit 3 and Visit 4

Secondary Endpoints

Ocular: Ciliary, episcleral, and inferior palpebral conjunctival redness; chemosis; lid swelling; tearing; ocular mucous discharge
Visit 3 and Visit 4
Nasal: Rhinorrhea; ear or palate pruritis; nasal pruritis; nasal congestion; and a composite score of all nasal symptoms
Visit 3 and Visit 4
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALKetotifen 4.0% Patch
2PLACEBO_COMPARATORPlacebo Patch
3ACTIVE_COMPARATORPataday(TM)
4PLACEBO_COMPARATORPlacebo eye drops

Interventions

NameTypeDescription
Ketotifen 4.0% PatchDRUGThis investigational drug is a transdermal patch indicated to treat allergic conjunctivitis. Application is intended for overnight wear between 8-10 hours.
PlaceboDRUGThe control is a placebo patch that contains only the inactive ingredients of ketotifen.
Olopatadine 0.2%DRUG1 gtt/eye on two separate occasions
Artificial tearsDRUG1 gtt/eye on two separate occasions
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 18 years of age of either sex and any race * positive history of ocular allergies and a positive skin test reaction to cat hair, cat dander, dog dander, grasses, ragweed, trees, dust mites, and/or cockroaches within the past 24 months * able and willing to avoid all disallowed...

Countries:United States
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Frequently asked questions about Ketotifen 4.0% Patch

What is Ketotifen 4.0% Patch used for?

Ketotifen 4.0% Patch is an investigational small molecule being developed for the treatment of allergic conjunctivitis. It is administered as a patch and is currently in Phase 2 clinical development. The drug is being evaluated for its safety and efficacy in patients with allergic conjunctivitis.

Who makes Ketotifen 4.0% Patch?

Ketotifen 4.0% Patch is being developed by BrainsWay Ltd., a company traded under the ticker BWAY. The company is conducting clinical trials to evaluate the patch for the treatment of allergic conjunctivitis.

What phase is Ketotifen 4.0% Patch in?

Ketotifen 4.0% Patch is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 clinical trial has been completed to assess its safety and efficacy in patients with allergic conjunctivitis.

What clinical trials is Ketotifen 4.0% Patch in?

Ketotifen 4.0% Patch has one completed Phase 2 clinical trial, identified as NCT00836485. This randomized, double-blind, placebo-controlled study enrolled 122 participants in the United States to evaluate the patch compared to placebo, olopatadine 0.2% ophthalmic solution, and artificial tears in the conjunctival allergen challenge model.

How does Ketotifen 4.0% Patch work?

Ketotifen 4.0% Patch is a small molecule that is being developed for allergic conjunctivitis. The specific molecular target of the drug has not been disclosed in the available information, so its exact mechanism of action is not detailed here.