Actively Recruiting
A Safety Study of IVMED-85 Ophthalmic Solution in Healthy Adults
Led by iVeena Delivery Systems, Inc. · Updated on 2026-02-05
36
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
I
iVeena Delivery Systems, Inc.
Lead Sponsor
L
Lexitas Pharma Services, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Safety Study of IVMED-85 Ophthalmic Solution in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 49 years
- Ability to provide written informed consent voluntarily
- Clinically healthy as determined by the investigator
- Willing and able to attend clinic visits and follow study procedures
- Willing and able to stop using topical eye medications unless approved by investigator (artificial tears allowed but not within 30 minutes before or after study drops)
- Best corrected visual acuity (BCVA) of 20/30 (logMAR 0.2) or better
- Corneal thickness between 450 and 670 micrometers
- Intraocular pressure (IOP) of 22 mmHg or less
- Willingness to not wear mascara for the 6-week study
- Willingness to avoid swimming in indoor pools for 6 weeks
You will not qualify if you...
- Participation in another clinical trial using investigational drugs within 30 days prior to screening or during this study
- Known allergy or sensitivity to copper or related disorders such as Wilson's disease
- Significant central corneal scarring or hydrops
- History or presence of punctal stenosis or bloody discharge
- History or presence of nasolacrimal duct or eyelid disorders including occlusion, trauma, cancer, ectropion, entropion, dacryocystitis, dacryoadenitis, chronic conjunctivitis, recurrent subconjunctival hemorrhage, trichiasis, distichiasis, or uncontrolled dry eye
- Previous eye surgeries including cornea, glaucoma, eyelid, strabismus, or intraocular surgeries
- Current or past ocular disorders such as strabismus, amblyopia, glaucoma, macular degeneration, cataract, retinal detachment, nystagmus, or abnormalities of the central cornea, lens, iris, ciliary body, or retina
- Medical conditions predisposing to craniofacial anomalies or abnormal eye anatomy like osteogenesis imperfecta or genetic syndromes listed
- Active or recent (within 2 weeks) bacterial, viral, or allergic conjunctivitis
- Active allergies causing uncontrolled eye or nasal symptoms
- Active sinusitis
- Current or past thyroid disorders
- Recent or ongoing chronic use (within 3 months) of preserved eye drops
- History of uncontrolled gastroesophageal reflux disease or deviated nasal septum
- For women of childbearing potential: pregnant, lactating, or unwilling to use effective contraception during the study
- For male participants with female partners of childbearing potential: unwillingness to use effective contraception during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Total Eye Care, P.A.
Memphis, Tennessee, United States, 38119
Actively Recruiting
Research Team
D
David Evans, OD
CONTACT
A
Ariel McNatt
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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