Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • IVMED-85 ophthalmic solution

    Drug

    IVMED-85 ophthalmic solution (0.20 mg/mL), administer twice a day (morning and evening) in both eyes

  • Vehicle Ophthalmic Solution

    Drug

    Vehicle ophthalmic solution, administer twice a day (morning and evening) in both eyes

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Vehicle ophthalmic solutionPlacebo comparator 1 intervention
Group B: IVMED-85 ophthalmic solutionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Visual acuity

Change from baseline in corrected distance visual acuity (CDVA) with Early Treatment Diabetic Retinopathy Study (ETDRS) in the study eye (SE) at all post-baseline visits. The change in ETDRS scores will be recorded as logMAR scores and letters missed on the eye chart. A logMAR of 0.0 corresponds to 20/20 vision; higher values indicate greater myopia (near-sighted), and lower values indicate greater hyperopia (far-sighted) .

Time frame
From enrollment to the end of treatment at 6 weeks
2

Change in eye assessments

Clinically significant Abnormalities in ocular assessments at any post-baseline visit

Time frame
From enrollment to the end of treatment at 6 weeks
3

Punctal stenosis or Bloody discharge

Development of punctal stenosis or bloody discharge over the course of the study

Time frame
From enrollment to the end of treatment at 6 weeks
4

Change in ocular assessments

Change from baseline in ocular symptoms assessment (discomfort, burning, irritation, photophobia, and redness) at all post-baseline visits.

Time frame
From enrollment to the end of treatment at 6 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

iVeena Delivery Systems, Inc.

Lead sponsor

Lexitas Pharma Services, Inc.

Collaborator

Source ClinicalTrials.gov
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