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Anticholinergic Agent
Atropine Eye Drops for Near-Sightedness
Phase 3
Waitlist Available
Research Sponsored by Ocumension (Hong Kong) Limited
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 at month 36
Awards & highlights
Study Summary
This trial is testing if atropine sulfate can treat myopia in children. It is a safety, tolerability, and efficacy study, which means they are testing how well and how safe the drug is.
Who is the study for?
This trial is for children with near-sightedness who have seen their condition worsen by at least -0.50D in the past year, and have less than or equal to 1.50DC of astigmatism. Kids can't join if they've had treatments for myopia control in the last 6 months or any eye surgery, or if they suffer from chronic eye inflammation.Check my eligibility
What is being tested?
The study tests OT-101 Ophthalmic Solution against a placebo (vehicle) to see if it's safe and effective for treating myopia in kids. It's a phase III trial where participants are randomly assigned to either the treatment or placebo group without knowing which one they're getting.See study design
What are the potential side effects?
Possible side effects of OT-101 may include discomfort in the eyes, dryness, redness, blurred vision, and potentially allergic reactions. The exact side effects will be monitored throughout the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at month 36
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at month 36
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of study eyes with a -0.75D of progressive myopia defined as an increase in spherical equivalent of -0.75D or greater as assessed by cycloplegic autorefraction.
Secondary outcome measures
Change in spherical equivalent (D) in the study eye as assessed by cycloplegic autorefraction
Eye
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: OT-101 plus vehicleExperimental Treatment2 Interventions
Atropine Sulfate 0.01% Ophthalmic Solution through year 3 followed by vehicle for 1 year
Group II: OT-101 aloneExperimental Treatment1 Intervention
Atropine Sulfate 0.01% Ophthalmic Solution through year 4
Group III: VehiclePlacebo Group1 Intervention
Vehicle (Investigational Product minus active ingredient) through year 4
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vehicle
2013
Completed Phase 3
~5070
Find a Location
Who is running the clinical trial?
Statistics & Data CorporationIndustry Sponsor
4 Previous Clinical Trials
379 Total Patients Enrolled
Ocumension (Hong Kong) LimitedLead Sponsor
ORA, Inc.Industry Sponsor
69 Previous Clinical Trials
8,358 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or had severe eye inflammation issues.I haven't used any special treatments to control nearsightedness in the last 6 months, except for regular glasses or soft contacts.I have had surgery to correct my vision.The person has had a progression of at least -0.50D of spherical equivalent in the last 12 months.The person has astigmatism that is less than or equal to 1.50 degrees.
Research Study Groups:
This trial has the following groups:- Group 1: Vehicle
- Group 2: OT-101 plus vehicle
- Group 3: OT-101 alone
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What sort of people would be the best subjects for this research?
"Currently, this study is recruiting 678 children with myopia that are aged between 3 and 15 years old. There are certain requirements that potential patients must meet which include: a progression of spherical equivalent by at least -0.50D in the last 12 months; and an astigmatism of 1.50DC or less."
Answered by AI
Is this research project open to those who are not yet 55 years old?
"The age limit for patients in this study is 15 years old. As long as they are 3 or older, they can participate."
Answered by AI
Are there any remaining openings for participants in this research?
"The study, which can be found on clinicaltrials.gov, is recruiting patients as of 11/1/2022. This page was first published on 4/1/2021."
Answered by AI
Does the FDA allow OT-101 Ophthalmic Solution to be sold?
"OT-101 Ophthalmic Solution received a safety score of 3 from our team because it is a Phase 3 trial. This means that there is both some efficacy data and multiple rounds of safety data available."
Answered by AI
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