PRO-232 in Patients Subjected to Cataract Surgery

Proportion of patients with grade 0 cellularity among interventions

Using a slit lamp, a detailed assessment of cellularity in the anterior chamber of the eye will be performed. Using a 0.5 X 8.0mm beam of light directed obliquely the degree of cellularity will be measured. The grade of cellularity in the anterior chamber will be reported acording to the following scale: Grade Number of cells Grade 0 (≤ 5 cells), grade 1+ (5-10 cells \[mild\]), grade 2+ (11-20 \[moderate\]), grade 3+ (21-50 \[marked\]), grade 4+ (over 50 \[severe\]). The evaluated population for this outcome measure will be the PP population (subjects who finished the study without presenting any mayor deviations to protocol).

Proportion of patients presenting unexpected adverse events (AE) related between interventions

The manifested adverse events during the conduction of this trial will be obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These will be 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. The classification as unexpected and/or related will be based in previously reported AE for the ingredients of the investigational products and comparators. This outcome measure considered the Intention-To-Treat (ITT) population, all participants who were randomized and exposed to treatment, regardless of whether they finished the study.

Degree of cellularity in the anterior chamber between interventions

Using a slit lamp, a detailed assessment of cellularity in the anterior chamber of the eye will be performed. Using a 0.5 X 8.0mm beam of light directed obliquely the degree of cellularity will be measured. The grade of cellularity in the anterior chamber will be reported acording to the following scale: Grade Number of cells Grade 0 (≤ 5 cells), grade 1+ (5-10 cells \[mild\]), grade 2+ (11-20 \[moderate\]), grade 3+ (21-50 \[marked\]), grade 4+ (over 50 \[severe\]). A higher score is a worse outcome. This outcome measure considered the Intention-To-Treat (ITT) population, all participants who were randomized and exposed to treatment, regardless of whether they finished the study.

Pain level score between interventions.

The patient's level of eye pain will be assessed using a visual analog scale (Wong-Baker FACES® Visual Analog Scale). The scoring system will be as follows: Severity: (0) Doesn't hurt, (2) Hurts a little, (4) Hurts a little more, (6) Hurts a lot, (8) Hurts too much, (10) Unbearable pain. A higher score is a worse outcome. This outcome measure considered the Intention-To-Treat (ITT) population, all participants who were randomized and exposed to treatment, regardless of whether they finished the study.

Changes in best corrected visual acuity (BCVA) measurement between interventions

The patient will be evaluated using his/her best refractive correction. BCVA is a test of visual function. It will be evaluated with the Snellen chart. The Snellen chart is the standard tool used to evaluate visual acuity. It was located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated. The contralateral eye to which it will be evaluated is covered, then the examiner detects until the line can clearly see the letters given he or she a score, the normal score for a VA is 20/20.This score can be expressed in fraction (i.e. 20/20) decimal (i.e. 1.0), or LogMAR (i.e. 0) formats. In this study, BCVA wiil be expressed in fraction and LogMAR formats. In fraction format and in LogMAR, a higher denominator number or number (respectively) is a worse outcome.

Proportion of patients who present an increase in intraocular pressure (IOP) ≥10 mmHg compared to baseline.

The IOP will be measured through Goldmann tonometer in milligrams of mercury (mmHg). After instillation of topical anesthetic (tetracaine 0.5%) and fluorescein stain, IOP will be evaluated. Normal values are considered between 10 and 21 mmHg.