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Corticosteroid
Atropine + Contact Lenses for Near-sightedness
Phase 4
Recruiting
Led By Donald O Mutti, OD, PhD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 months
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
"This trial aims to see how low-dose atropine eye drops and soft multifocal contact lenses affect the shape of the eyes of nearsighted young adults. Participants will have various eye tests and
Who is the study for?
This trial is for nearsighted young adults who currently wear contact lenses, have normal binocular vision, and a visual acuity of 20/25 or better. They will be assessed at the first visit to confirm eligibility.
What is being tested?
The study compares low-dose atropine eye drops used nightly with soft multifocal contact lenses worn daily against no intervention to see if they change the shape of the peripheral eye and affect focusing over 12 months.
What are the potential side effects?
Potential side effects may include discomfort from wearing contacts, reactions to atropine such as dry mouth, blurred vision, sensitivity to light, and possible dilation-related side effects during eye health checks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in ocular shape
Secondary study objectives
Axial elongation (or regression)
Change in accommodative response
Change in refractive error
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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
3Treatment groups
Experimental Treatment
Active Control
Group I: Soft multifocal contact lensesExperimental Treatment1 Intervention
Participants randomized to soft multifocal contact lenses will wear MiSight 1-day disposable contact lenses for 5-7 days per week for 12 months.
Group II: Low-dose atropineExperimental Treatment1 Intervention
Participants randomized to low-dose atropine will instill one drop of 0.05% atropine in each eye at bedtime for 12 months.
Group III: ObservationActive Control1 Intervention
Participants randomized to the observation arm will receive no intervention.
Find a Location
Who is running the clinical trial?
Ohio State UniversityLead Sponsor
871 Previous Clinical Trials
655,657 Total Patients Enrolled
Donald O Mutti, OD, PhDPrincipal InvestigatorOhio State University
3 Previous Clinical Trials
122 Total Patients Enrolled
Donald O. Mutti, OD, PhDPrincipal InvestigatorOhio State University
1 Previous Clinical Trials
6 Total Patients Enrolled