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
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
Connect with a study center
IIMET Investigación e Innovación en Medicina Traslacional
Guadalajara, Jalisco 44610
MexicoSite Not Available
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