Safety Study of IVMED-85 Ophthalmic Solution in Healthy Adults
This study is testing the safety of IVMED-85 ophthalmic solution, an eye drop, in healthy adults. Researchers want to see if IVMED-85 eye drops cause any side effects. You might receive either the IVMED-85 eye drops or a vehicle ophthalmic solution (a control eye drop without the active ingredient). You would use the eye drops twice a day for 6 weeks. The study will look at your vision, eye health, and check for issues like punctal stenosis (narrowing of the tear duct) or bloody discharge. This study is for healthy adults aged 18 to 49 and is currently recruiting 36 participants.
- Study design
- This is a randomized, double-masked (meaning neither you nor the researchers will know which eye drops you are receiving), controlled study involving 36 healthy adults.
- What's involved
- You would use eye drops twice daily for 6 weeks and attend 3 clinic visits (at the start, Day 21, and Day 42).
- Compensation
- Not stated in the trial record.
- Follow-up
- If you experience any treatment-related side effects, you may have additional follow-up visits for up to 3 months after your last study visit.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Safety Study of IVMED-85 Ophthalmic Solution in Healthy Adults
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Visual acuityFrom 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 assessmentsFrom enrollment to the end of treatment at 6 weeks
Clinically significant Abnormalities in ocular assessments at any post-baseline visit
- Punctal stenosis or Bloody dischargeFrom 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 assessmentsFrom 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.