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Anticholinergic

experimental for Near-sightedness

Phase 3
Waitlist Available
Research Sponsored by The V.P. Vyhodcev Eye Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline - 12 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Pivotal Trial

Summary

This trial tests if using a small amount of atropine eye drops can slow down worsening eyesight in Russian children with nearsightedness. The study aims to see if this treatment is safe and effective without causing significant side effects. Researchers are particularly interested in whether it works as well in Russian children as it does in Asian children. Atropine eye drops at low concentrations have been shown to slow myopia progression in children in various studies, including those conducted in East Asia and the USA.

Eligible Conditions
  • Near-sightedness

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline - 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline - 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
change in axial length
change in myopic progression rate
Secondary study objectives
change in difference between manifest and cycloplegic refractions
change in positive relative accommodation
tear production

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: experimentalExperimental Treatment1 Intervention
0.01% Atropine Sulfate solution in "Comfort Drops", nightly instillations to both eyes

Find a Location

Who is running the clinical trial?

The V.P. Vyhodcev Eye HospitalLead Sponsor
~12 spots leftby Nov 2025
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