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Efficacy of IVMED-85 on Pediatric Myopia

NCT05761795 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2023-09-29

No results posted yet for this study

Summary

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 myopia by assessing its safety effects on visual acuity and its effect on the change and/or progression of myopia.

The main question\[s\] it aims to answer are:

* Does IVMED 85 improve visual acuity
* Does IVMED 85 slow or otherwise change the progression of myopia

Participants will use eyedrops twice a day for one year. Researchers will compare IVMED 85 to a placebo.

Conditions

  • Myopia, Progressive

Interventions

DRUG

IVMED 85

Eye drop

DRUG

Placebo

Placebo eye drop

Sponsors & Collaborators

  • iVeena Delivery Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Sarah Molokhia · iVeena Delivery Systems, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2026-05-31
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05761795 on ClinicalTrials.gov