Safety and Tolerability Evaluation of PRO-230 Ophthalmic Solution

Study Overview
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Brief Summary
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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)

Detailed Description
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A total of 29 healthy volunteers will apply PRO-230 ocular solution on both eyes QD (one time per day) for 14 days. The safety variables will include non expected AE, pupillary diameter and expected AE; tolerability variables will include incidence of photofobia, and BNCVA. Exploratory variables include best corrected visual acuity (BCVA), intraocular pressure (IOP), corneal an conjunctival staining with fluorescein and lissamine green, vital signs (heart rate and blood pressure), and results of the Ocular Confort Index (OCI) questionnaire. The presence of non-expected AE < 10% will deem PRO-230 as safe; while an incidence of photophobia < 30% will deem PRO-230 as tolerable.

Official Title
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Phase I Clinical Trial to Evaluate the Safety and Tolerability of the Ophthalmic Solution PRO-230 When Applied to 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. 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.

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, non comparative, open, unicentric.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRO-230<br>Healthy volunteers will apply one drop of PRO-230 ophthalmic solution (atropine sulphate) on both eyes, QD (one time per day) for 14 days. | Drug: Atropine Sulfate<br>* Atropine Sulfate 0.05% Ophthalmic Solution<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 | Change 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 previously described / known for the active substance in this pharmaceutic form and concentration. | Through Day 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. | Time Frame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit) |