MyopiaPhase 1PRO-201NCT05470881
Phase I Clinical Trial to Evaluate the Safety and Tolerability of Ophtalmic Solution PRO-201
A Phase 1 study testing Atropine Sulfate in people with Myopia, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
Trial summary
Evaluation of the safety and tolerability of PRO-201 (0.01% sulfate atropine) after its instillation on the ocular surface of healthy volunteers through the following variables: unexpected adverse events incidence and photophobia (primary outcome variables); as well as pupillary diameter, expected adverse events… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Atropine Sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteMexico
- Study dates
- 20 Aug 2022to 26 Dec 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
IIMET Investigación e Innovación en Medicina Traslacional
Guadalajara, Jalisco, 44610
About this study
Official title: Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-201 Ophthalmic Solution Applied on the Ocular Surface of Healthy Volunteers.
Evaluation of the safety and tolerability of PRO-201 (0.01% sulfate atropine) after its instillation on the ocular surface of healthy volunteers through the following variables: unexpected adverse events incidence and photophobia (primary outcome variables); as well as pupillary diameter, expected adverse events incidence, best near corrected visual acuity (BNCVA), best corrected visual acuity (BCVA), intraocular pressure (IOP), corneal and conjunctival staining, heart rate, blood pressure and ocular confort index (OCI),
Read the detailed description
A total of 29 healthy volunteers will be enrolled in this study. They will receive one drop of the investigation product PRO-201 (0.01% atropine sulfate) once a day (QD) for a total of 14 days on both eyes. A final safety call will be performed one week after the last day of product application.
- Conditions
- Myopia
- Being tested
- Atropine Sulfate
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine SulfateDrug
Administration of one drop QD on both eyes for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| PRO-201 | Experimental | A total of 29 anticipated healthy volunteers will be exposed to the investigation product. Receives: Drug: Atropine Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Unexpected Adverse Events
The number of adverse events presented that are not previously described / known for the active substance in this pharmaceutic form and concentration.
Measured: Through Day 21 ± 1 (Safety Call)
Number of Patients With Photophobia
The number of cases of photophobia.
Measured: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Secondary outcomes (3)
Pupillary Diameter
Measurement of pupillary diameter after exposure to the investigation product.
Measured: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Percentage of Expected Adverse Events
The percentage of adverse events presented that are expected, or previously described / known for the active substance in this pharmaceutic form and concentration.
Measured: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit), 21 ± 1 (Safety Call)
Measurement of the Change in Best Near Corrected Visual Acuity (BCNVA)
The change in BCNVA after exposure to investigation product, compared to basal value.
Measured: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start20 Aug 2022
- Primary completion26 Dec 2022
- Study completion26 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase I, controlled, non-comparative, open, unicentric study.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Sophia S.A de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470881
- Sponsor's protocol ID
- SOPH201-0521/I
- Acronym
- PRO-201
- Status last verified
- Feb 2026
- First submitted
- 23 Mar 2022
- Last updated
- 5 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-201 Ophthalmic Solution Applied on the Ocular Surface of Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT05470881
- Acronym / sponsor ID
- PRO-201 / SOPH201-0521/I
- Conditions
- Myopia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2022 (actual)
- Primary completion
- 26 Dec 2022 (actual)
- Study completion
- 26 Dec 2022 (actual)
- First posted
- 22 Jul 2022 (actual)
- Results
- Posted 5 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the safety and tolerability of PRO-201 (0.01% sulfate atropine) after its instillation on the ocular surface of healthy volunteers through the following variables: unexpected adverse events incidence and photophobia (primary outcome variables); as well as pupillary diameter, expected adverse events incidence, best near corrected visual acuity (BNCVA), best corrected visual acuity (BCVA), intraocular pressure (IOP), corneal and conjunctival staining, heart rate, blood pressure and ocular confort index (OCI),
Detailed description
A total of 29 healthy volunteers will be enrolled in this study. They will receive one drop of the investigation product PRO-201 (0.01% atropine sulfate) once a day (QD) for a total of 14 days on both eyes. A final safety call will be performed one week after the last day of product application.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase I, controlled, non-comparative, open, unicentric study.
| Arm | Type | Receives |
|---|---|---|
| PRO-201 | Experimental | Drug: Atropine SulfateA total of 29 anticipated healthy volunteers will be exposed to the investigation product. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atropine SulfateAdministration of one drop QD on both eyes for 14 days. | Drug | PRO-201 |
Primary outcome
Number of Unexpected Adverse Events
Time frame: Through Day 21 ± 1 (Safety Call)
The number of adverse events presented that are not previously described / known for the active substance in this pharmaceutic form and concentration.
Number of Patients With Photophobia
Time frame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
The number of cases of photophobia.
3 secondary outcomes
Pupillary Diameter
Time frame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Percentage of Expected Adverse Events
Time frame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit), 21 ± 1 (Safety Call)
Measurement of the Change in Best Near Corrected Visual Acuity (BCNVA)
Time frame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Atropine Sulfate in people with Myopia, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Unexpected Adverse Events (time frame: Through Day 21 ± 1 (Safety Call)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.