Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
F# 13418-148 Eye · 1 trial · 1 indication
Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.
The responder was defined as a subject whose assessment score at 60 seconds after the initial eye drop is less than the assessment score at baseline. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.
| Arm | Type | Description |
|---|---|---|
| Formula # 13418-148 | EXPERIMENTAL | - |
| Formula # 13418-158 | EXPERIMENTAL | - |
| Control Formula # PF004390 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| F# 13418-148 Eye Drops | DRUG | ocular clear liquid. Tetrahydrozoline 0.05%; Glycerin 0.40% 1-2 drops will be instilled as instructed over one day |
| F#13418-158 Eye Drops | DRUG | ocular clear liquid Tetrahydrozoline 0.05%; Glycerin 0.20%, Hypromellose 0.2%, Polyethylene glycol 400 1.0% 1-2 drops will be instilled as instructed over one day |
| F# PF-004390 Eye Drops | DRUG | Ocular clear liquid Tetrahydrozoline 0.05%; 1-2 drops will be instilled as instructed over one day |
Inclusion Criteria: 1. Able and willing to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment; 2. Able and willing to provide a signed and dated Informed Consent document and Authorization for the Rel...
F# 13418-148 Eye is an investigational small molecule ophthalmic solution being developed for use in eye care. It is intended for application as eye drops. The drug is currently in Phase 3 clinical development and is being studied in the United States.
F# 13418-148 Eye is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is an investigational ophthalmic solution in Phase 3 clinical development.
F# 13418-148 Eye is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 clinical trial for the drug has been completed.
F# 13418-148 Eye was studied in a completed Phase 3 clinical trial with the identifier NCT03198000. The trial, titled "A Study to Evaluate the Efficacy of Investigational OTC Eye Drops," enrolled 120 participants in the United States and was randomized, double-blind, and active-controlled.
F# 13418-148 Eye is an investigational ophthalmic solution being studied for potential over-the-counter use. The completed Phase 3 trial evaluated the efficacy of the investigational eye drops, but the drug remains in clinical development and is not yet available as an approved product.