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Atropine Eye Drops for Near-Sightedness
Study Summary
This trial will study the effects of microdosed atropine on myopia progression, administering the solution daily for 48 months. Eligible subjects will be re-randomized at the 36 month visit and followed for an additional year.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have had surgery on my eyelid, for eye alignment, inside my eye, or to correct my vision.I have a condition like diabetes that could affect my eyesight.I do not have any severe eye problems or unstable health conditions that could interfere with the study.You have used hard contact lenses, including orthokeratology lenses, within the past 90 days before the screening.My child was born prematurely.You are allergic to atropine.I have a history of eye conditions or surgery that affects my vision.People who have a habit of squeezing their eyelids.I have used atropine or similar eye drops for myopia.I have not had eye inflammation in the last 30 days.You have different coloration in your eyes.Refractive correction for each eye must meet the following criteria: myopia within ± 0.50 D of the manifest refraction at the Screening Visit; cylinder power within ± 0.50 D of the manifest refraction at the Screening Visit; when cylinder power is < 1.00 D, axis within ± 15 degrees of the manifest refraction; when cylinder power is ≥ 1.00 D, axis within ± 5 degrees of the manifest refraction.I have a refractive error of between -1.00 and -6.00 in both eyes, with astigmatism of ≤ 1.50 in both eyes and anisometropia of < 1.50.The person has a best-corrected visual acuity of 0.2 logMAR or better in their current correction and an interocular difference of ≤ 0.1 logMAR.I have an eye condition affecting parts like the cornea or retina.I have had a procedure to block my tear ducts.I cannot undergo certain tests due to existing neurological or genetic conditions.I have or had crossed eyes, lazy eye, or involuntary eye movement.
- Group 1: Atropine 0.01% Ophthalmic Solution
- Group 2: Atropine 0.1% Ophthalmic Solution
- Group 3: Placebo Ophthalmic Solution
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Are we still recruiting people for this experiment?
"The information readily available on clinicaltrials.gov verifies that this study is still searching for participants. This particular trial was first posted on 6/3/2019 and has been actively recruiting since then. As of right now, the goal is to have 420 participants enrolled from 19 different sites."
What other scientific research has utilized Atropine 0.01% Ophthalmic Solution?
"At the moment, there are 22 Atropine 0.01% Ophthalmic Solution trials underway. Of those, 6 have reached Phase 3. Although a majority of these trials are based in Shanghai, China, there are 149 total locations running these tests worldwide."
Has the FDA given its okay to use Atropine 0.01% Ophthalmic Solution?
"Power gave atropine a safety score of 3 because it is in Phase 3 clinical trials. This means that, while there is still some testing to be done, the medication has shown efficacy and multiple rounds of data support its safety."
What condition does Atropine 0.01% Ophthalmic Solution help alleviate?
"Ophthalmic Solution Atropine 0.01% is used to treat conditions such as uncontrollable laughing, rhinorrhoea, and an overabundance of bile fluid."
What are the requirements for participants in this clinical trial?
"This clinical trial is looking for 420 participants who are between the ages of 3 and 12 and have myopia. The following refractive correction criteria must be met: myopia within ± 0.50 D of the manifest refraction at the Screening Visit; cylinder power within ± 0.50 D of the manifest refraction at the Screening Visit; when cylinder power is < 1.00 D, axis within ± 15 degrees of the manifest refraction; when cylinder power is ≥ 1.00 D, axis within ± 5 degrees of the manifest refraction., Best-corrected distance visual acuity in current correction of 0."
Does this research involve seniors or are they restricted to a younger age group?
"The age requirements to participate in this particular trial are that applicants must be between 3 and 12 years old. Out of the 102 total clinical trials, 76 are for patients younger than 18 while 26 are for senior citizens."
How many individuals are being studied in this clinical trial?
"420 individuals that meet the eligibility for this clinical study are required in order for data to be collected. Eyenovia Inc., is sponsoring the trial and will have locations at Vanderbilt University Medical Center and Midwestern University."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
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Most responsive sites:
- Marshall Ketchum University College of Optometry: < 24 hours
Average response time
- < 1 Day
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