Phase I Study to evaluate safety and tolerability of PRO-185 (naphazoline/hypromellose) ophthalmic solution through evaluation of vital signs, ocular signs such as intraocular pressure, hyperemia and mydriasis and adverse events.

A total of 22 healthy volunteers will apply PRO-185 ocular solution on both eyes QID (four times per day) for 8 days. The safety variables will include intraocular pressure, heart rate, systolic and diastolic blood pressure. Tolerability variables will include: hyperemia, mydriasis, and expected and unexpected adverse events. The presence of any of these in ≤ 20% will deem PRO-185 as safe and tolerable.

Inclusion Criteria:

• Being clinically healthy
• Having the ability to grant a signed informed consent
• Being able and willing to comply with the programmed visits, treatment plan and other procedures of this study.
• Age between 18 and 45 years
• Women in child-bearing age must assure the continuation (start ≥ 30 days previous to the signing of the ICF) of a hormonal contraceptive method or a intrauterine device (IUD) during the period of the study.
• Best corrected visual acuity equal of better than 20/30 in both eyes.
• Vital signs within normal ranges.
• Intraocular pressure ≥10 and ≤ 21 mmHg

Exclusion Criteria:

• Using any kind of topic ophthalmic products
• Presenting allergies to naphazoline or the history of intolerance to nasal decongestants or ocular vasoconstrictive products.
• History of diagnosis of suspicion of primary angle closure, primary angle closure or closed angle glaucoma.
• History of iridotomies or waiting for this procedure to take place.
• Conjunctival hyperemia grade 3 or 4 according to Efron scale.
• Ocular surface staining equal or greater to 3 in the SICCA scale, for any eye.
• Using medications or herbology products, through any route of administration.
• Pregnant, breastfeeding or women who plan to get pregnant during the period of the study.
• Previous participation in any clinical study 90 days prior to the inclusion in the present study.
• Previous participation in this study.
• Using contact lenses which cannot be suspended during the period of this study.
• History of any chronic illness, including diabetes and hypertension.
• Active inflammation or infection at the time of inclusion in this study.
• Unresolved lesions or traumas at the moment of inclusion in this study.
• History of any kind of ocular surgery.
• History of any surgical procedure, non-ophthalmologic, within the previous 3 months to the inclusion in this study.

The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.

From day 1 (basal visit) to final visit on day 10 (±1 days)

The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.