Phase I Clinical Trial to Evaluate the Safety and Tolerability of Ophtalmic Solution PRO-201 (NCT05470881) | Clinical Trial Compass
CompletedPhase 1
Phase I Clinical Trial to Evaluate the Safety and Tolerability of Ophtalmic Solution PRO-201
Mexico29 participantsStarted 2022-08-20
Plain-language 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),
Who can participate
Age range18 Years – 35 Years
SexALL
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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.
* Inability to follow the lifestyle considerations of this study.
* History of any chronic degenerative disease, includi…