J&J's TECNIS IOL trial posts results; Ebola vaccine study also completed

This week's J&J-linked activity centers on completed trial results plus a newly recruiting study.

• J&J Surgical Vision's device trial comparing the TECNIS Test IOL Model DEN00V against Control IOL Model DCB00 in 245 participants with cataracts¹ is completed, with results posted. The trial's primary outcome measured monocular photopic distance-corrected intermediate visual acuity at 66 cm for the first operative eye¹, and results showed the Test IOL scored 0.15 logMAR versus 0.31 logMAR for Control¹, with a p-value below 0.0001¹. Serious adverse events occurred in 13 of 115 Test IOL patients and 8 of 113 Control IOL patients.
• A Phase 2 Ebola vaccine study led by Universiteit Antwerpen, with J&J as a collaborator, has completed. The study evaluated immunogenicity and safety of a heterologous vaccine regimen using Ad26.ZEBOV as first dose followed by MVA-BN-Filo 56 days later in health care providers in the Democratic Republic of the Congo², with an additional randomized booster component.
• A Phase 4 study sponsored by Massachusetts General Hospital, with J&J K.K. as a collaborator, is now recruiting. The trial is examining how lumateperone affects mood symptoms and inflammation in adults with bipolar disorder over approximately 6 weeks, with an MRI scan to calculate brain biological age at baseline³, enrolling an estimated 25 participants.