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New eye drops for nearsightedness pass early safety check

NCT ID NCT05470881

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

29 people

The number who actually took part.

Started

Aug 2022

Finished

Dec 2022

Lead sponsor

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

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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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