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

Study Overview
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Brief Summary
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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),

Detailed Description
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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.

Official Title
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Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-201 Ophthalmic Solution Applied on the Ocular Surface of Healthy Volunteers.

Conditions
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Myopia

Intervention / Treatment
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* Drug: Atropine Sulfate


Participation Criteria
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Eligibility Criteria
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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, 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. Hypersensitivity or lack of tolerance to any of the ingredients used during the study'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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Phase I, controlled, non-comparative, open, unicentric study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRO-201<br>A total of 29 anticipated healthy volunteers will be exposed to the investigation product. | Drug: Atropine Sulfate<br>* Administration of one drop QD on both eyes for 14 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence 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) | 
| Incidence of photophobia | The number of cases of photophobia. | Through Day 21 ± 1 (Safety Call) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pupillary Diameter | Measurement of pupillary diameter after exposure to the investigation product. | Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit) | 
| Incidence of expected adverse events | The number of adverse events presented that are not previously described / known for the active substance in this pharmaceutic form and concentration. | 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 (BNCVA) | The change in BNCVA after exposure to investigation product, compared to basal value. | Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit) |