Study to Evaluate the Safety and Tolerability of PRO-231 Versus VIGAMOXI® on the Ocular Surface of Healthy Subjects

Inclusion Criteria:

• Having the ability to voluntarily give their signed informed consent.

• Ophthalmologically and clinically healthy subjects.

• Being able to and willing to comply with scheduled visits, treatment plan, and otherstudy procedures.

• Age between 18 to 45 years.

• Male or female gender.

• Women of childbearing potential who have not undergone Bilateral Tubal Occlusion (BTO [Tubal Ligation]), hysterectomy, or bilateral oophorectomy must ensurecontinuation (initiated ≥ 30 days prior to signing the informed consent form [ICF])of the use of a hormonal contraceptive method or intrauterine device (IUD) duringthe study period.

• Best corrected visual acuity (BCVA) of 20/30 or better in both eyes.

• Corneal staining ≤ grade I on the Oxford Scale.

• Having an intraocular pressure ≥ 10 and ≤ 21 mmHg.

Exclusion Criteria:

• History of hypersensitivity to fluoroquinolones, steroid anti-inflammatories, or anyof the components of the drugs under investigation.

• Use of ophthalmic medications from any pharmacological group.

• Use of medications by any other route of administration.

• Use of non-steroidal anti-inflammatory drugs, steroid anti-inflammatory drugs, orantibiotics by any route of administration in the last 30 days.

• History of eye surgery in the last 6 months.

• Use of contact lenses for a period less than two weeks prior to the start of thestudy, and during the intervention period of this study.

• In the case of women: being pregnant, breastfeeding, or planning to become pregnantwithin the study period.

• Having participated in any clinical research study 30 days prior to inclusion inthis study.

• Having previously participated in this same study.

• History of any chronic-degenerative disease, including Diabetes Mellitus or SystemicArterial Hypertension.

• Diagnosis of glaucoma or ocular hypertension.

• Known diagnosis of liver or heart disease.

• Presenting active inflammatory or infectious disease at the time of entry into thestudy.

• Presenting unresolved lesions or traumas at the time of entry into the study.

• Having been subjected to non-ophthalmological surgical procedures in the last 3months.

• Being or having an immediate family member (e.g., spouse, parent/legal guardian,sibling, or child) who is an employee of the research site or the sponsor, and whodirectly participates in this study.

• Active smoking (specified as the consumption of cigarettes regardless of the amountand frequency, 4 weeks prior to study inclusion and during the intervention periodof this study).

• Active alcoholism (specified as the consumption of alcoholic beverages, regardlessof the amount and frequency, 72 hours prior to study inclusion and during theintervention period of this study).

Elimination Criteria

• Withdrawal of their consent to participate in the study (informed consent form).

• Occurrence of a serious adverse event, whether related or not to the interventions,that in the opinion of the principal investigator (PI) and/or the sponsor, couldaffect the patient's fitness to safely continue with the study procedures.

• Non-tolerability or hypersensitivity to any of the compounds used during the tests -(fluorescein, tetracaine).

• Non-tolerability or hypersensitivity to any of the drugs under investigation.

• Adherence < 80% determined by the subject's diary and corroborated by the finalweight of the research products (RP) compared to the initial weight.