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senofilcon A TEST Lens, senofilcon A CONTROL Lens · 1 trial · 2 indications
Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Observations from each study period are treated as independent (for the descriptive summary only). The average of all observations for each lens was reported.
Overall vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Observations from each study period are treated as independent (for the descriptive summary only). The average of all observations for each lens was reported.
| Arm | Type | Description |
|---|---|---|
| TEST/CONTROL/CONTROL | EXPERIMENTAL | Subjects that are of 18 years or older and current spherical soft contact lens wearers will wear the Test and Control lenses for two weeks each in random order with one of the study lenses being worn twice for a total of 6 weeks per subject. |
| CONTROL/TEST/TEST | EXPERIMENTAL | Subjects that are of 18 years or older and current spherical soft contact lens wearers will wear the Test and Control lenses for two weeks each in random order with one of the study lenses being worn twice for a total of 6 weeks per subject. |
| Name | Type | Description |
|---|---|---|
| senofilcon A TEST Lens | DEVICE | senofilcon A with new UV blocker investigational process |
| senofilcon A CONTROL Lens | DEVICE | senofilcon A with new UV blocker standard process |
Inclusion Criteria: * Potential subjects must satisfy all of the following criteria to be enrolled in the study: 1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. 2. Appear able and willing to adhere to the instructi...
Senofilcon A TEST Lens is an investigational contact lens being studied for the correction of refraction error and attenuation of bright light. It is in Phase 2 clinical development and is not approved by the FDA. The lens is intended for use in ophthalmology to address refractive errors.
Senofilcon A TEST Lens is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical trials to evaluate the safety and effectiveness of this investigational contact lens for correcting refractive errors.
Senofilcon A TEST Lens is in Phase 2 clinical development. It is an investigational product and has not received FDA approval. The Phase 2 trial has been completed, and the lens is being studied for the correction of refraction error and attenuation of bright light.
Senofilcon A TEST Lens has one completed Phase 2 clinical trial registered as NCT03475875, titled "Contact Lenses With New UV-blocker Manufactured With Different Techniques." The trial enrolled 92 participants in the United States, with healthy volunteers aged 18 years and older, and included both male and female subjects.
Senofilcon A TEST Lens and senofilcon A CONTROL Lens are distinct products studied in the same clinical trial. The TEST lens is the investigational product, while the CONTROL lens serves as a comparator in the controlled, double-blind study. Both are contact lenses developed by Johnson & Johnson for refractive error correction.