NCT07370584

A Safety Study of IVMED-85 Ophthalmic Solution in Healthy Adults

A Randomized, Vehicle-Controlled, Double-Masked Study of the Safety of IVMED-85 Ophthalmic Solution in Healthy Adults

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: iVeena Delivery Systems, Inc. · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of this trial is to determine the safety of IVMED-85 eye drops in healthy adult subjects. Participants will be assigned to either the active or vehicle eyedrop group. The participants will receive eye drops twice daily for 6 weeks. Participants will not know which eyedrop they are taking.

Detailed description

Randomized, double-masked, controlled studies are the gold standard of clinical research. This is a randomized, vehicle-controlled, double-masked Phase 1 clinical study to assess the safety of IVMED-85 ophthalmic solution in healthy adult subjects. 36 subjects (ages 18-49) will be randomly and equally assigned to one of two treatment groups: vehicle ophthalmic solution or 0.20 mg/mL IVMED-85 ophthalmic solution. All subjects will dose twice daily (BID), morning and evening, in both eyes for 6 weeks. Subjects will attend 3 clinic visits (screening/baseline, Day 21, and Day 42 at which safety will be assessed. If any treatment-related adverse events occur, additional visits to monitor for resolution and/or treatment, at the Investigator's discretion, with at least 1 such visit occurring months 3 after the last study visit. In this study, the vehicle is the control treatment, chosen to help ensure that any effect observed in the IVMED-85 group is due to the active ingredient. IVMED-85 will be administered as an eye drop, a common route of administration.

Conditions

• Safety Study

Interventions

Type	Name	Description
DRUG	IVMED-85 ophthalmic solution	IVMED-85 ophthalmic solution (0.20 mg/mL), administer twice a day (morning and evening) in both eyes
DRUG	Vehicle Ophthalmic Solution	Vehicle ophthalmic solution, administer twice a day (morning and evening) in both eyes

Timeline

• Start date: 2026-02-04
• Primary completion: 2026-05-01
• Completion: 2026-07-01
• First posted: 2026-01-27
• Last updated: 2026-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study