Safety and Tolerability Evaluation of PRO-230 Ophthalmic Solution

• Status: Not yet recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase I Study to evaluate safety and tolerability of PRO-230 (atropine sulphate 0.05%) ophthalmic solution through evaluation of incidence of non-expected adverse events (AE), photophobia, pupillary diameter, incidence of expected adverse events, and best near corrected visual acuity (BNCVA)

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Laboratorios Sophia S.A de C.V.
• Treatments: Atropine

Criteria

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.

• 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.