Trials / Not Yet Recruiting

Not Yet RecruitingNCT05761795

Efficacy of IVMED-85 on Pediatric Myopia

A Randomized, Controlled, Double-Masked Adaptive Design Evaluation of the Safety and Preliminary Efficacy of IVMED-85 on Pediatric Myopia

Status: Not Yet Recruiting
Phase: Phase 1 / Phase 2
Study type: Interventional
Enrollment: 216 (estimated)

Sponsor: iVeena Delivery Systems, Inc. · Industry
Sex: All
Age: 5 Years – 16 Years
Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	IVMED 85	Eye drop
DRUG	Placebo	Placebo eye drop

Timeline

Start date: 2024-02-01
Primary completion: 2026-05-01
Completion: 2026-12-01
First posted: 2023-03-09
Last updated: 2023-09-29

Source: ClinicalTrials.gov record NCT05761795. Inclusion in this directory is not an endorsement.