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

Last updated: December 5, 2023
Sponsor: Laboratorios Sophia S.A de C.V.
Overall Status: Completed

Phase

1

Condition

Myopia

Treatment

Atropine Sulfate

Clinical Study ID

NCT05470881
SOPH201-0521/I
  • Ages 18-35
  • All Genders
  • Accepts Healthy Volunteers

Study 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),

Eligibility Criteria

Inclusion

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 theintervention 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 theICF) the use of a hormonal contraception method of a intrauterine device (IUD) duringthe period of the study.
  • Best corrected visual acuity (BVCA) of at least 20/30 (logMAR 0.2) or better in botheyes.
  • Best near corrected visual acuity (BNVCA) of at least 20/25 (logMAR 0.1) or better inboth eyes.
  • Presenting vital signs within normal parameters.
  • Presenting an IOP ≥10 and ≤ 21 mmHg

Exclusion

Exclusion Criteria:

  • Using any kind of ophthalmic topical products.
  • Presenting known allergy or intolerance to any ingrediente of atropine eyedrops or anyother derivatives of antimuscarinic agents.
  • Using any medication of herbolary products (plant extracts, infusions, naturistpreparations, homeopathy, etc) through any route of administration
  • For women: being pregnant, breastfeeding or planning to get pregnant during the periodof the study.
  • Having participated in any clinical study 90 days prior to the inclusion in thisstudy.
  • 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 thisstudies.
  • 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 inthis study. Elimination criteria:
  • Withdraw of ICF.
  • Adverse event, related or not to the investigation product, that according to theprincipal investigator and/or the sponsor may affect the integrity of the patient tocontinue safely with the study's procedures.
  • Hypersensitivity or lack of tolerance to any of the ingredients used during thestudy'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.

Study Design

Total Participants: 29
Treatment Group(s): 1
Primary Treatment: Atropine Sulfate
Phase: 1
Study Start date:
August 20, 2022
Estimated Completion Date:
December 26, 2022

Study 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.

Connect with a study center

  • IIMET Investigación e Innovación en Medicina Traslacional

    Guadalajara, Jalisco 44610
    Mexico

    Site Not Available

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