Approval Probability
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KetoNaph · 1 trial · 1 indication
An adverse event was defined as unfavorable and unintended sign, symptom, or disease temporally associated with the use of a test article, whether or not considered related to test article.
| Arm | Type | Description |
|---|---|---|
| KetoNaph | EXPERIMENTAL | KetoNaph Ophthalmic Solution |
| Vehicle | PLACEBO_COMPARATOR | Vehicle of KetoNaph Ophthalmic Solution |
| Name | Type | Description |
|---|---|---|
| KetoNaph | DRUG | Ophthalmic Solution administered BID for 6 weeks |
| Vehicle | DRUG | Vehicle of KetoNaph ophthalmic solution administered bid for six weeks |
Inclusion Criteria: * Subjects less than 18 years of age, have either a history or family history of ocular allergy. * ocular health within normal limits, including a calculated best-corrected visual acuity of 0.3 logMar or better, in each eye. For subjects under 10 years old who are developmentall...
KetoNaph is an investigational small molecule being developed for the treatment of allergic conjunctivitis, a condition affecting the eye. It is formulated as an ophthalmic solution and is currently in Phase 3 clinical development. The drug is being studied in patients as young as 2 years old.
The specific molecular target of KetoNaph is not disclosed in available information. The drug is being developed as an ophthalmic solution for allergic conjunctivitis, but its mechanism of action has not been publicly detailed. It is classified as a small molecule therapeutic.
KetoNaph is being developed by Bausch + Lomb Corporation, a company traded on the New York Stock Exchange under the ticker symbol BLCO. The company is conducting clinical trials to evaluate the safety and efficacy of this ophthalmic solution for allergic conjunctivitis.
KetoNaph is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 3 trial has been completed, which is typically the final stage before a marketing application is submitted.
KetoNaph has one completed Phase 3 clinical trial registered as NCT01159015, titled 'Study Evaluating the Safety of KetoNaph Ophthalmic Solution in Healthy Volunteers.' The trial enrolled 534 participants with allergic conjunctivitis, was randomized, double-blind, and placebo-controlled. It included healthy volunteers aged 2 years and older.
KetoNaph is not FDA approved. It is an investigational drug currently in Phase 3 clinical development. A Phase 3 trial has been completed, but regulatory approval has not been granted. The drug remains under evaluation for the treatment of allergic conjunctivitis.