Safety testing of IVMED-85 eye drops in healthy adults

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

This trial will test if IVMED-85 eye drops are safe for healthy adults ages 18 to 49 when used twice daily for six weeks.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 49 Years
• Sex: All
• Sponsor: iVeena Delivery Systems, Inc. (Industry-sponsored)
• Locations: 1 site (Memphis, Tennessee)
• Trial ID: NCT07370584 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-masked, vehicle-controlled Phase 1 trial enrolling 36 healthy adults who will be equally assigned to receive either IVMED-85 ophthalmic solution (0.20 mg/mL) or a matching vehicle. Participants will dose both eyes twice daily (morning and evening) for 6 weeks and attend in-person clinic visits at screening/baseline, Day 21, and Day 42 for safety assessments. The trial focuses on ocular safety measures including vision, corneal thickness, and intraocular pressure, with additional follow-up visits if any treatment-related adverse events occur. The vehicle control helps distinguish effects of the active ingredient from the drop formulation itself.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18–49 with good baseline vision, corneal thickness of 450–670 μm, IOP ≤22 mmHg, willing to stop topical ocular medications and follow study restrictions such as avoiding mascara and indoor swimming for 6 weeks.

Not a fit: People with existing eye disease, out-of-range corneal thickness or intraocular pressure, those who cannot stop topical ocular medications, or anyone outside the 18–49 age range are unlikely to be eligible or receive benefit from this safety-focused study.

Why it matters

Potential benefit: If shown to be safe, IVMED-85 could advance to later trials and potentially become an eye-drop option for eye conditions like myopia.

How similar studies have performed: Early-phase safety studies of topical ophthalmic products are common and many have shown acceptable safety profiles, but IVMED-85 itself is a novel formulation being tested in humans for the first time.

Eligibility criteria

Inclusion Criteria:

* 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.

  1. Age 18-49. -
  2. Ability to voluntarily provide written informed consent. -
  3. Being clinically healthy, as determined by the investigator. -
  4. Willing and able to comply with clinic visits and study-related procedures. -
  5. Willing and able to discontinue use of topical ocular medications, unless approved by investigator. Note: Artificial tears are allowed but must not be used within 30 minutes before or after administration of the study investigational product (IP). -
  6. BCVA better than or equal to 0.2 logarithm of the minimum angle of resolution (logMAR) (20/30 Snellen equivalent). -
  7. Corneal thickness 450 to 670 μm. -
  8. Intraocular pressure (IOP) ≤22 mmHg. -
  9. Willingness to not wear mascara for 6 weeks of the study. -
  10. Willingness to not swim in an indoor pool for 6 weeks of the study. -

Exclusion Criteria:

Subjects who meet any of the following criteria at Visit 1 will not be eligible to enroll in the study. Ocular criteria apply to either eye.

1. 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. -
2. Known copper allergy, sensitivity, or processing disorder (e.g., Wilson's disease). -
3. Presence of significant central corneal scarring or hydrops. -
4. History or presence of punctal stenosis or bloody discharge. -
5. History of or presence of nasolacrimal duct occlusion, nasolacrimal system trauma, nasolacrimal or eyelid cancer, ectropion or entropion, dacryocystitis, dacryoadenitis, chronic conjunctivitis, recurrent subconjunctival hemorrhage, trichiasis, distichiasis, or uncontrolled dry eye. -
6. Previous cornea, glaucoma, eyelid, strabismus (exotropia or esotropia), or intraocular surgeries. -
7. Current or previous ocular disorder, including but not limited to: strabismus (exotropia or esotropia), amblyopia, glaucoma, macular degeneration, cataract, retinal detachment or nystagmus, or abnormality of the central cornea, lens, iris, ciliary body, or central retina. -
8. Presence of any medical condition predisposing the subject to craniofacial anomalies, degenerative myopia, or abnormal ocular refractive anatomy (e.g., osteogenesis imperfecta or Stickler, Down, Ehlers-Danlos, Donnai-Barrow, Treacher-Collins, or Apert/Crouzon/ Pfeiffer syndrome). -
9. Active or recent (within 2 weeks prior to screening) bacterial, viral, or allergic conjunctivitis. -
10. Active allergies causing uncontrolled ocular and nasal symptoms. -
11. Active sinusitis. -
12. Current or previous hypothyroidism or hyperthyroidism. -
13. Ongoing or recent (within 3 months prior to screening) chronic use of eyedrops containing preservatives such as benzalkonium chloride (BAK), Purite, or Polyquad. -
14. History of uncontrolled gastroenteric reflux disease or deviated nasal septum. -
15. If a female of childbearing potential (FOCBP):

    1. Are pregnant or lactating.
    2. Are unwilling to use an effective form of contraception (e.g., hormonal, oral, transdermal, implant, injection, or abstinence) for the duration of the study. -
16. A male subject with a partner who is a FOCBP unwilling to use an effective form of contraceptives (e.g., barrier, hormonal, oral, transdermal, implant, injection, or abstinence) for either themselves or their partner, as appropriate, for the duration of the study. -

Where this trial is running

Memphis, Tennessee

• Total Eye Care, P.A. — Memphis, Tennessee, United States (Recruiting)

Study contacts

• Study coordinator: David Evans, OD

Conditions Safety Study; eye drops; safety; myopia