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etafilcon A with ketotifen · 1 trial · 1 indication
Monocular contact lens-corrected distance visual acuity was assessed using a logMAR visual acuity scale. This was evaluated for each eye, under high luminance and high contrast conditions at 4 meters from ETDRS charts. Distance visual acuity was reported by lens type and visit.
Monocular contact lens-corrected distance visual acuity was assessed using a logMAR visual acuity scale. This was evaluated for each eye, under high luminance and high contrast conditions at 4 meters from ETDRS charts. Distance visual acuity was reported by lens type and visit.
| Arm | Type | Description |
|---|---|---|
| K-Lens | ACTIVE_COMPARATOR | etafilcon A with ketotifen. Subjects between the ages of 18-40 will be randomized into the K-Lens arm and will be scheduled for a total of two study visits with approximately 6-9 days in between. |
| Placebo Contact Lens | PLACEBO_COMPARATOR | 1-Day Acuvue. Subjects between the ages of 18-40 will be randomized into the Placebo arm and will be scheduled for a total of two study visits with approximately 6-9 days in between. |
| Name | Type | Description |
|---|---|---|
| etafilcon A with ketotifen | COMBINATION_PRODUCT | Etafilcon A with ketotifen |
| 1-Day ACUVUE | DEVICE | 1-Day ACUVUE |
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 instructio...
Etafilcon A with ketotifen is an investigational small molecule being developed for visual acuity in the ophthalmology therapeutic area. It is a contact lens material combined with the antihistamine ketotifen. The drug is currently in Phase 2 clinical development and is not yet approved by the FDA.
Etafilcon A with ketotifen is being developed by Johnson & Johnson (NYSE: JNJ). The company is conducting clinical trials to evaluate the safety and efficacy of this investigational product for visual acuity. The drug is currently in Phase 2 development.
Etafilcon A with ketotifen is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 2 trial has been completed, involving 143 participants, to evaluate the product for visual acuity.
Etafilcon A with ketotifen has one completed clinical trial, NCT03388138, titled "Clinical Evaluation of Etafilcon A With Ketotifen." This Phase 2 study enrolled 143 participants in the United States, was randomized, double-blind, and placebo-controlled, and included healthy volunteers aged 18 years and older.
No, etafilcon A with ketotifen is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. A Phase 2 trial has been completed, but the product has not yet received regulatory approval for any use.