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

ConditionSafety Study

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-49

SponsoriVeena Delivery Systems, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

Subjects who meet all the following inclusion criteria at Visit 1 will be eligible to enroll in the study. Ocular criteria apply to both eyes.

Age 18-49. -

Ability to voluntarily provide written informed consent. -

Being clinically healthy, as determined by the investigator. -

Disqualifiers

Participation in a clinical trial with the use of any investigational drug or treatment within 30 days prior to Visit 1 and duration of the study. -

Known copper allergy, sensitivity, or processing disorder (e.g., Wilson's disease). -

Presence of significant central corneal scarring or hydrops. -

History or presence of punctal stenosis or bloody discharge. -

Trial design

Treatments tested in this trial

IVMED-85 ophthalmic solution
Vehicle Ophthalmic Solution

Treatment groups

36 Participants

are divided into 2 treatment groups

Sponsors and collaborators

iVeena Delivery Systems, Inc.

Lead sponsor

Lexitas Pharma Services, Inc.

Collaborator

Source ClinicalTrials.gov