Safety and Tolerability of PRO-143 Ophthalmic Solution in Healthy Volunteers. (PRO-143)

Eksperymentalny: PRO-143 Ophthalmic Solution

PRO-143 Ophthalmic Solution applied four times per day (c/6 hours) during 10 days.

Lek: PRO-143 Ophthalmic Solution

PRO-143 Ophthalmic Solution applied four times per day (C/6 hours) during 10 days.

Inne nazwy:

• PRO-143

Conjunctival bulbar hyperemia

Conjunctival hyperemia is defined as the simplest reaction of the conjunctiva to a stimulus, a red appearance secondary to the vasodilation of the conjunctival vessels of variable intensity. He will graduate using the Efron scale.

0 Normal , 1 Very slight, 2 Mild, 3 Moderate, 4 Severe.

Number of Participants with adverse events

he evaluation of adverse events requires a questioning conducted by the principal investigator and the appropriate exploratory techniques for its detection. the number of adverse events per study group will be considered for the analysis

Intraocular pressure (IOP)

Tonometry is the objective measure of Intraocular pressure, based primarily on the force required to flatten the cornea, or the degree of corneal indentation produced by a fixed force. Goldman's tonometry is based on the Imbert-Fick principle. the result will be expressed in millimeters of mercury and the comparison between groups will be carried out.

Visual ability (VA)

The VA will be evaluated basally, without refractive correction with the Snellen chart. Which will be located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated

Eye comfort index (ICO)

It is a questionnaire designed to measure the irritation of the ocular surface with Rasch analysis to produce estimates on a linear scale of intervals (ratings: 0-100). Similar to the index for ocular surface diseases, the ocular comfort index (ICO) evaluates symptoms. The ICO contains 6 items that focus on the discomfort associated with the ocular surface. Each of these questions has two parts, which inquire separately the frequency and severity of the symptoms.

The evaluator will deliver the questionnaire to the subject and allow the subject to answer it calmly without any pressure and / or coercion, will only assist him if he has difficulty understanding any of the questions.