New eye drops for nearsightedness pass early safety check
NCT ID NCT05470881
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested the safety of PRO-201 eye drops (a low-dose atropine solution) in 29 healthy adults aged 18 to 35. The main goal was to see if the drops cause unexpected side effects or light sensitivity. Researchers also checked vision, eye pressure, and comfort. The study is complete, but results are not yet available.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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29 people
The number who actually took part.
- Started
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Aug 2022
- Finished
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Dec 2022
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 35 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Being clinically healthy * Ability to voluntarily sign an informed consent form (ICF). * Ability and willingness to comply with the scheduled visits according to the intervention plan and other procedures of the study. * Age between 18 and 35. * Absence of history of contact lens use. * Women of childbearing age must agree to continue (starting ≥ 30 days previous to the ICF) the use of a hormonal contraception method of a intrauterine device (IUD) during the period of the study. * Best corrected visual acuity (BVCA) of at least 20/30 (logMAR 0.2) or better in both eyes. * Best near corrected visual acuity (BNVCA) of at least 20/25 (logMAR 0.1) or better in both eyes. * Presenting vital signs within normal parameters. * Presenting an IOP ≥10 and ≤ 21 mmHg Exclusion Criteria: * Using any kind of ophthalmic topical products. * Presenting known allergy or intolerance to any ingrediente of atropine eyedrops or any other derivatives of antimuscarinic agents. * Using any medication of herbolary products (plant extracts, infusions, naturist preparations, homeopathy, etc) through any route of administration * For women: being pregnant, breastfeeding or planning to get pregnant during the period of the study. * Having participated in any clinical study 90 days prior to the inclusion in this study. * Having participated in this clinical study. * Inability to follow the lifestyle considerations of this study. * History of any chronic degenerative disease, including diabetes and hypertension. * Presenting active inflammatory or infectious diseases when entering this study. * Presenting unresolved lesions or trauma when entering this study. * History of any ocular surgery. * History of any surgery, non-ocular, within the previous 3 months of entering this studies. * Being or having an direct family member (spouse, parent/legal guardian, sibling, etc) as employee of the investigation site or the sponsor, who participates directly in this study. Elimination criteria: * Withdraw of ICF. * Adverse event, related or not to the investigation product, that according to the principal investigator and/or the sponsor may affect the integrity of the patient to continue safely with the study's procedures. * Hypersensitivity or lack of tolerance to any of the ingredients used during the study's procedures (fluorescein, lissamine green, tetracaine, etc) * Hypersensitivity or lack of tolerance to the investigation product. * Presenting an adherence to treatment \< 90%, as determined through the subjects diary.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
IIMET Investigación e Innovación en Medicina Traslacional
Guadalajara, Jalisco, 44610, Mexico
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Other studies related to the condition(s) this trial covers.
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