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Antisense Oligonucleotide
SHJ002 for Near-sightedness
Phase 2
Waitlist Available
Research Sponsored by Sunhawk Vision Biotech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female, age 3-12 years
Able to tolerate eye drops in both eyes
Must not have
Previous incisional or laser surgery
Active or recent history of severe ocular infection or inflammation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test the safety and effectiveness of SHJ002 Sterile Ophthalmic Solution compared to atropine for controlling myopia. SHJ002 is a type of medication that works by
Who is the study for?
This trial is for individuals with near-sightedness, particularly those whose myopia is worsening (degenerative or progressive). Specific eligibility details are not provided, but typically participants must meet certain health standards and may need to have a specific level of myopia.
What is being tested?
The study tests the safety and effectiveness of SHJ002 Sterile Ophthalmic Solution compared to atropine in controlling myopia. SHJ002 is designed to target a microRNA related to eye growth.
What are the potential side effects?
While side effects are not detailed here, common ones for ophthalmic solutions include eye irritation, redness, discomfort, blurred vision, or allergic reactions. Atropine can cause light sensitivity and difficulty focusing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 3 and 12 years old.
Select...
I can use eye drops in both eyes without issues.
Select...
I can avoid certain medications and won't change my vision correction.
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I am a man who can father children and will use two forms of birth control.
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I agree to use two reliable birth control methods if I can have children.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had incisional or laser surgery before.
Select...
I have had a severe eye infection or inflammation recently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SHJ002Experimental Treatment1 Intervention
The assigned eyedrops will be instilled in both eyes once per day, one drop per application, 7 days a week, for 52 weeks.
Group II: AtropineActive Control1 Intervention
The assigned eyedrops will be instilled in both eyes once per day, one drop per application, 7 days a week, for 52 weeks.
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Who is running the clinical trial?
Sunhawk Vision Biotech, Inc.Lead Sponsor
2 Previous Clinical Trials
134 Total Patients Enrolled
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