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Also known as F# 13418-148 Eye Drops
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 developed by Johnson & Johnson for ophthalmic use. It is also known as F# 13418-148 Eye Drops. The product is in Phase 3 clinical development and has been studied in a completed trial evaluating investigational over-the-counter eye drops.
F# 13418-148 Eye is being developed as an ophthalmic solution, meaning it is intended for eye-related use. Its only recorded clinical study enrolled healthy adult volunteers and evaluated investigational over-the-counter eye drops. The specific medical condition it is intended to treat has not been established through an approved indication.
F# 13418-148 Eye is developed by Johnson & Johnson, which trades under the ticker JNJ. The company is the sponsor behind the ophthalmic solution program, including the Phase 3 study conducted in the United States.
F# 13418-148 Eye is in Phase 3 clinical development. It is an investigational product and is not approved for commercial use. One Phase 3 trial has been completed, and no trials are currently active.
F# 13418-148 Eye has been studied in one Phase 3 trial, NCT03198000, titled A Study to Evaluate the Efficacy of Investigational OTC Eye Drops. That trial enrolled 120 participants in the United States, was randomized, double blind, and active controlled, and has completed.
Yes, F# 13418-148 Eye Drops is an alternative name for F# 13418-148 Eye. Both names refer to the same Johnson & Johnson ophthalmic solution in Phase 3 development, so readers searching either name are looking at the same investigational asset.