Phase I Clinical Trial to Evaluate the Safety and Tolerability of Ophtalmic Solution PRO-201

NCT05470881 | Completed Phase 1 Results DMC

• 1 other identifier: SOPH201-0521/I
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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 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),

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• 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.

  Through Day 21 ± 1 (Safety Call)

• Number of Patients With Photophobia

  The number of cases of photophobia.

  Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)

Secondary Outcomes (3)

• Pupillary Diameter

  Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)

• Percentage of Expected Adverse Events

  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)

  Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)

Other Outcomes (6)

• Changes in Intraocular Pressure (IOP)

  Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)

• Number of Cases With Corneal and Conjunctival Staining With Fluorescein

  Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)

• Measurement of Vital Signs (Systolic Blood Pressure)

  Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)

Study Arms (1)

PRO-201

EXPERIMENTAL

A total of 29 anticipated healthy volunteers will be exposed to the investigation product.

Drug: Atropine Sulfate

Interventions

Atropine Sulfate DRUG

Administration of one drop QD on both eyes for 14 days.

PRO-201

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Laboratorios Sophia S.A de C.V.: lead

Study Sites (1)

IIMET Investigación e Innovación en Medicina Traslacional

Guadalajara, Jalisco, 44610, Mexico

Location

MeSH Terms

Conditions

Myopia

Interventions

Atropine

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Alejandra Sanchez-Ríos M.D.
• Organization: Laboratorios Sophia

alejandra.sanchez@sophia.com.mx

:+52 (33) 3001 4200

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase I, controlled, non-comparative, open, unicentric study.

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: July 22, 2022
• Study Start: August 20, 2022
• Primary Completion: December 26, 2022
• Study Completion: December 26, 2022
• Last Updated: February 5, 2026
• Results First Posted: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)