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

NCT07370584 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: IVNA 22-02
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Safety Study

Keywords

eye drops; safety; myopia

Outcome Measures

Primary Outcomes (4)

• 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) .

  From enrollment to the end of treatment at 6 weeks

• Change in eye assessments

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

  From enrollment to the end of treatment at 6 weeks

• Punctal stenosis or Bloody discharge

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

  From enrollment to the end of treatment at 6 weeks

• Change in ocular assessments

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

  From enrollment to the end of treatment at 6 weeks

Study Arms (2)

Vehicle ophthalmic solution

PLACEBO COMPARATOR

Vehicle ophthalmic solution, administered twice a day

Drug: Vehicle Ophthalmic Solution

IVMED-85 ophthalmic solution

EXPERIMENTAL

IVMED-85 ophthalmic solution (0.20 mg/mL)

Drug: IVMED-85 ophthalmic solution

Interventions

IVMED-85 ophthalmic solution DRUG

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

IVMED-85 ophthalmic solution

Vehicle Ophthalmic Solution DRUG

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

Vehicle ophthalmic solution

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-49. -
• Ability to voluntarily provide written informed consent. -
• Being clinically healthy, as determined by the investigator. -
• Willing and able to comply with clinic visits and study-related procedures. -
• 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). -
• BCVA better than or equal to 0.2 logarithm of the minimum angle of resolution (logMAR) (20/30 Snellen equivalent). -
• Corneal thickness 450 to 670 μm. -
• Intraocular pressure (IOP) ≤22 mmHg. -
• Willingness to not wear mascara for 6 weeks of the study. -
• Willingness to not swim in an indoor pool for 6 weeks of the study. -

You may not qualify if:

• 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.
• 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. -
• 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. -
• Previous cornea, glaucoma, eyelid, strabismus (exotropia or esotropia), or intraocular surgeries. -
• 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. -
• 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). -
• Active or recent (within 2 weeks prior to screening) bacterial, viral, or allergic conjunctivitis. -
• Active allergies causing uncontrolled ocular and nasal symptoms. -
• Active sinusitis. -
• Current or previous hypothyroidism or hyperthyroidism. -
• Ongoing or recent (within 3 months prior to screening) chronic use of eyedrops containing preservatives such as benzalkonium chloride (BAK), Purite, or Polyquad. -
• History of uncontrolled gastroenteric reflux disease or deviated nasal septum. -

Sponsors & Collaborators

• iVeena Delivery Systems, Inc.: lead
• Lexitas Pharma Services, Inc.: collaborator

Study Sites (1)

Total Eye Care, P.A.

Memphis, Tennessee, 38119, United States

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

David Evans, OD

CONTACT

901-761-4620; tneyedoc@mac.com

Ariel McNatt

CONTACT

901-761-4620; Akalafat6060@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: January 27, 2026
• Study Start: February 4, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)