This first-in-human, randomized, pivotal trial evaluated the safety and efficacy of CK2-085, a transparent, self-assembling peptide gel, for improving intraoperative visibility in glaucoma surgery. Sixty-eight glaucoma patients were randomized 1:1 to surgery with or without CK2-085. Subjective interoperative visibility evaluation (IVE), surgical feasibility evaluation (SFE) and Diathermy Evaluation (DE) scores were used to assess the surgery itself. Postoperatively, the surgical outcome was assessed by measurements of intraocular pressure (IOP), best-corrected visual acuity and corneal endothelial cell density, along with slit lamp microscopic and fundus examinations and an evaluation of adverse events. Intraoperative visibility when using CK2-085, scored at 51.5%, was significantly higher than that in the control, non-CK2-085 group (17.6%, p = 0.004). However, the surgical feasibility evaluation showed the CK2-085 group failed to establish non-inferiority against non-CK2-085 groups, which may have been affected by the surgeon’s learning curve. Analysis confirmed that the difference in diathermy use did not confound these findings. IOP one month after the operation was not significantly different between the CK2gel and control groups (p = 0.54). Occasional adverse events were temporary and occurred equally in both groups. CK2-085 is a safe and effective material for use in the maintenance of intraoperative visibility during glaucoma surgery.
Matsushita et al. (Mon,) studied this question.