NCT05592912

Safety and Efficacy of HydroLenz for Vitrectomy-Induced Lens Opacities

Safety and Preliminary Efficacy of Two Dose Levels of HydroLenz as a Protectant for Vitrectomy-Induced Lens Opacities in Subjects Undergoing Vitrectomy

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: PromiSight, LLC · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to provide safety data for two different dosages of HydroLenz. Secondary objectives are to provide preliminary data to determine whether HydroLenz has the same effect in humans as it does in the porcine model; to confirm the reliability of methods for evaluating lens opacity; and, to acquire information that can be used to design the pivotal study.

Conditions

• Pars Plana Vitrectomy

Interventions

Type	Name	Description
DRUG	HydroLenz Injection	The HydroLenz injection will be administered at the conclusion of the vitrectomy procedure on the operative day
OTHER	No HydroLenz Injection	No HydroLenz injection will be administered at the conclusion of the vitrectomy procedure on the operative day.

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2022-10-25
• Last updated: 2025-07-25

Regulatory

• FDA-regulated drug study