IVMED-85 for Healthy Adults
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety of IVMED-85 eye drops in healthy adults. Participants will use either the active eye drops or a placebo (inactive drops) without knowing which one, twice daily for six weeks. The trial seeks adults who are generally healthy, do not have significant eye conditions, and are willing to avoid certain eye products and activities like mascara and indoor swimming for six weeks. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
You may need to stop using any topical eye medications unless the study investigator approves them. Artificial tears are allowed, but you can't use them within 30 minutes before or after the study eye drops.
Is there any evidence suggesting that IVMED-85 ophthalmic solution is likely to be safe for humans?
Research shows that IVMED-85 eye drops are non-surgical and non-invasive, requiring neither surgery nor additional devices. A study in rabbits found these drops safe and effective, indicating potential for human use.
In human studies, no serious side effects have been reported so far. Participants used the drops daily without needing additional treatments like UV light or implants. The absence of serious side effects suggests that IVMED-85 is well-tolerated in healthy adults. However, these findings are still preliminary, and further research is needed to fully understand the safety of these eye drops.12345Why do researchers think this study treatment might be promising?
Researchers are excited about IVMED-85 ophthalmic solution because it offers a new approach to eye health. While most eye treatments rely on traditional active ingredients like antibiotics or anti-inflammatories, IVMED-85 features a novel compound at a concentration of 0.20 mg/mL. This could potentially provide a unique mechanism of action that targets eye conditions differently. The experimental treatment stands out due to its potential to deliver effective results with a twice-daily application, offering convenience and innovation in eye care.
What evidence suggests that IVMED-85 ophthalmic solution could be effective?
Research has shown that IVMED-85 eye drops, which participants in this trial may receive, might help slow the progression of nearsightedness (myopia). In earlier studies, eyes treated with these drops experienced less worsening of myopia compared to untreated eyes. The eye drops enhance a natural process that strengthens the eye's outer layers, potentially preventing shape changes that worsen vision. Although further research is necessary, these early results are promising.13678
Are You a Good Fit for This Trial?
This trial is for healthy adults who are near-sighted. Participants will be using eye drops and must not know which type they're receiving. Specific eligibility details aren't provided, but typically, participants should meet certain health standards.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either IVMED-85 or vehicle ophthalmic solution twice daily for 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, with additional visits if adverse events occur
What Are the Treatments Tested in This Trial?
Interventions
- IVMED-85 Ophthalmic Solution
Trial Overview
The study is testing the safety of IVMED-85 ophthalmic solution compared to a vehicle (placebo) solution in treating near-sightedness. Participants will use the assigned eye drops twice daily for six weeks without knowing which one they have.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
IVMED-85 ophthalmic solution (0.20 mg/mL)
Vehicle ophthalmic solution, administered twice a day
Find a Clinic Near You
Who Is Running the Clinical Trial?
iVeena Delivery Systems, Inc.
Lead Sponsor
Lexitas Pharma Services, Inc.
Industry Sponsor
Citations
A Safety Study of IVMED-85 Ophthalmic Solution in ...
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 ...
2.
optometrytimes.com
optometrytimes.com/view/iveena-submits-ind-to-fda-for-a-phase-2-clinical-trial-for-pediatric-myopiaiVeena submits IND to FDA for a phase 2 clinical trial ...
IVMED-85 effectively reduced myopia progression in treated eyes while untreated eyes continued to progress. While there was no difference in ...
Topical Eyedrops Increasing Lysyl Oxidase Activity ...
We provide the first evidence that our proprietary IVMED-85 eyedrops induce biochemical crosslinking and biomechanical stiffening in cornea and sclera and ...
Efficacy of IVMED-85 on Pediatric Myopia
The goal of this clinical trial is to evaluate the safety and preliminary efficacy of a 1-year course of IVMED-85 eye drops for the treatment of pediatric ...
5.
glance.eyesoneyecare.com
glance.eyesoneyecare.com/stories/2025-06-05/iveena-submits-ind-to-fda-for-pediatric-myopia-clinical-trial/iVeena submits IND to FDA for pediatric myopia clinical trial
As for the project itself: It sought to test IVMED-85's safety in rabbits to determine its safety and efficacy and generate feasibility results.
Advancing Myopia Therapy with IVMED-85
IVMED-85, if approved, does not require surgery, implants, or corneal scraping, and it does not need a UV source or additional devices. It has a ...
iVeena Delivery Systems Announces First Patient Dosed in ...
IVMED-85 is a non-surgical, non-invasive, non-atropine daily eye drop that strengthens scleral and corneal collagen crosslinks through LOX ...
Efficacy of IVMED-85 on Pediatric Myopia - ClinicalTrials.Veeva
The goal of this clinical trial is to evaluate the safety and preliminary efficacy of a 1-year course of IVMED-85 eye drops for the treatment of pediatric ...
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