Safety StudyPhase 1NCT07370584
A Safety Study of IVMED-85 Ophthalmic Solution in Healthy Adults
A Phase 1 study testing IVMED-85 ophthalmic solution in people with Safety Study, run by iVeena Delivery Systems, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Study
- What is being tested?
- IVMED-85 ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2026to 13 May 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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. -
- 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). -
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- 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. -
Who cannot join
- 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. -
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- 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. -
- 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, as appropriate, for the duration of the study. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Vehicle-Controlled, Double-Masked Study of the Safety of IVMED-85 Ophthalmic Solution in Healthy Adults
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.
Read the detailed description
Randomized, double-masked, controlled studies are the gold standard of clinical research. This is a randomized, vehicle-controlled, double-masked Phase 1 clinical study to assess the safety of IVMED-85 ophthalmic solution in healthy adult subjects. 36 subjects (ages 18-49) will be randomly and equally assigned to one of two treatment groups: vehicle ophthalmic solution or 0.20 mg/mL IVMED-85 ophthalmic solution.
All subjects will dose twice daily (BID), morning and evening, in both eyes for 6 weeks. Subjects will attend 3 clinic visits (screening/baseline, Day 21, and Day 42 at which safety will be assessed. If any treatment-related adverse events occur, additional visits to monitor for resolution and/or treatment, at the Investigator's discretion, with at least 1 such visit occurring months 3 after the last study visit.
In this study, the vehicle is the control treatment, chosen to help ensure that any effect observed in the IVMED-85 group is due to the active ingredient. IVMED-85 will be administered as an eye drop, a common route of administration.
- Conditions
- Safety Study
- Being tested
- IVMED-85 ophthalmic solution, Vehicle Ophthalmic Solution
- Keywords
- eye drops, safety, myopia
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVMED-85 ophthalmic solutionDrug
IVMED-85 ophthalmic solution (0.20 mg/mL), administer twice a day (morning and evening) in both eyes
Vehicle Ophthalmic SolutionDrug
Vehicle ophthalmic solution, administer twice a day (morning and evening) in both eyes
| Study group | Role | What they receive |
|---|---|---|
| Vehicle ophthalmic solution | Placebo comparator | Vehicle ophthalmic solution, administered twice a day Receives: Drug: Vehicle Ophthalmic Solution |
| IVMED-85 ophthalmic solution | Experimental | IVMED-85 ophthalmic solution (0.20 mg/mL) Receives: Drug: IVMED-85 ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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) .
Measured: 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
Measured: 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
Measured: 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.
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start4 Feb 2026
- Primary completion1 Apr 2026
- Study completion13 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- iVeena Delivery Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lexitas Pharma Services, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370584
- Sponsor's protocol ID
- IVNA 22-02
- Status last verified
- Nov 2026
- First submitted
- 19 Jan 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified patient data that underlie the results reported in future publications, along with the protocol and statistical analysis plan, will be made available upon reasonable request. Data will be available beginning 12 months following publication and may be accessed by qualified researchers who submit methodologically sound proposal, subject to approval and execution of a data sharing agreement
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Vehicle-Controlled, Double-Masked Study of the Safety of IVMED-85 Ophthalmic Solution in Healthy Adults
- ClinicalTrials.gov ID
- NCT07370584
- Acronym / sponsor ID
- IVNA 22-02
- Conditions
- Safety Study
- Keywords
- eye drops, safety, myopia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- iVeena Delivery Systems, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Lexitas Pharma Services, Inc.
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 13 May 2026 (actual)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Randomized, double-masked, controlled studies are the gold standard of clinical research. This is a randomized, vehicle-controlled, double-masked Phase 1 clinical study to assess the safety of IVMED-85 ophthalmic solution in healthy adult subjects. 36 subjects (ages 18-49) will be randomly and equally assigned to one of two treatment groups: vehicle ophthalmic solution or 0.20 mg/mL IVMED-85 ophthalmic solution.
All subjects will dose twice daily (BID), morning and evening, in both eyes for 6 weeks. Subjects will attend 3 clinic visits (screening/baseline, Day 21, and Day 42 at which safety will be assessed. If any treatment-related adverse events occur, additional visits to monitor for resolution and/or treatment, at the Investigator's discretion, with at least 1 such visit occurring months 3 after the last study visit.
In this study, the vehicle is the control treatment, chosen to help ensure that any effect observed in the IVMED-85 group is due to the active ingredient. IVMED-85 will be administered as an eye drop, a common route of administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vehicle ophthalmic solution | Placebo comparator | Drug: Vehicle Ophthalmic SolutionVehicle ophthalmic solution, administered twice a day |
| IVMED-85 ophthalmic solution | Experimental | Drug: IVMED-85 ophthalmic solutionIVMED-85 ophthalmic solution (0.20 mg/mL) |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (19 listed)
- 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. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVMED-85 ophthalmic solutionIVMED-85 ophthalmic solution (0.20 mg/mL), administer twice a day (morning and evening) in both eyes | Drug | IVMED-85 ophthalmic solution |
| Vehicle Ophthalmic SolutionVehicle ophthalmic solution, administer twice a day (morning and evening) in both eyes | Drug | Vehicle ophthalmic solution |
Primary outcome
Visual acuity
Time frame: From enrollment to the end of treatment at 6 weeks
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) .
Change in eye assessments
Time frame: From enrollment to the end of treatment at 6 weeks
Clinically significant Abnormalities in ocular assessments at any post-baseline visit
Punctal stenosis or Bloody discharge
Time frame: From enrollment to the end of treatment at 6 weeks
Development of punctal stenosis or bloody discharge over the course of the study
Change in ocular assessments
Time frame: From enrollment to the end of treatment at 6 weeks
Change from baseline in ocular symptoms assessment (discomfort, burning, irritation, photophobia, and redness) at all post-baseline visits.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Yes. Deidentified patient data that underlie the results reported in future publications, along with the protocol and statistical analysis plan, will be made available upon reasonable request. Data will be available beginning 12 months following publication and may be accessed by qualified researchers who submit methodologically sound proposal, subject to approval and execution of a data sharing agreement
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IVMED-85 ophthalmic solution in people with Safety Study, run by iVeena Delivery Systems, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: From enrollment to the end of treatment at 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.