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Tests treatment safety and results for Safety Study
Official title A Safety Study of IVMED-85 Ophthalmic Solution in Healthy Adults
ClinicalTrials.gov ID: NCT07370584
What this study is testing
What is IVMED-85 ophthalmic solution?
IVMED-85 ophthalmic solution is an investigational medicine, given as an once-daily, being studied as a potential treatment for safety study.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 49. Healthy volunteers may be eligible.
You may be able to join if
- people who meet all the following 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. -
- Willing and able to comply with clinic visits and study-related procedures. -
You likely can't join if
- people 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...
See the full eligibility criteria
- people who meet all the following 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. -
- 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...
- 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. -
- people 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...
- 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...
- 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...
- 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. -
- If a female of childbearing potential (FOCBP):
- Are pregnant or lactating.
- Are unwilling to use an effective form of contraception (e.g., hormonal, oral, transdermal, implant, injection, or abstinence) for the duration of the study. -
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Memphis, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 49 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Memphis, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.