Safety and Tolerability of the PRO-174 Versus Sophixín Ofteno®, on the Ocular Surface of Healthy Subjects

Phase 1CompletedNCT03519516

Laboratorios Sophia S.A de C.V.30 enrolled

Overview

Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic solution PRO-174 versus Sophixín Ofteno®, elaborated by Laboratorios Sophia, S.A. of C.V. on the ocular surface of ophthalmologically and clinically healthy subjects. Goals: Methodology: Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory. Number of patients: 30 subjects, divided into 2 groups \[15 subjects (30 eyes) exposed per group\] Test product, dose and route of administration, lot number: * PRO-174. Levofloxacin 0.5% ophthalmic solution. Prepared by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico. * Dosage: 1 drop every 2 hours during the waking period (8 daily applications), on day 1 and 2; continuing with 1 drop every 4 hours during the waking period (4 daily applications) from day 3 to 7. Both eyes. * Route of administration: ophthalmic Duration of treatment: 7 days Statistical methodology: The data will be expressed with measures of central tendency: mean and standard deviation for the quantitative variables. The qualitative variables will be presented in frequencies and percentages. The statistical analysis will be carried out through the Mann-Whitney U test for the quantitative variables for the difference between the groups. The intra-group difference will be made with the Wilcoxon rank test. The difference between the qualitative variables will be analyzed by means of X2 (Chi2). An alpha ≤ 0.05 will be considered significant.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Interventions

PRO-174DRUG

Pharmaceutical form: ophthalmic solution * Prepared by: Laboratorios Sophia, S.A. of C.V. * Description of the solution: transparent solution, free of visible particles. * Description of container: sterile multi-dose bottle

Sophixín Ofteno®DRUG

* Active substance: Ciprofloxacin 0.3% * Pharmaceutical form: Ophthalmic solution * Prepared by: Laboratorios Sophia, S.A. of C.V. * Description of the solution: transparent solution, free of visible particles. * Description of container: sterile multi-dose bottle

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Signed informed consent. * Systemically and ophthalmologically healthy subjects evaluated during the clinical history. * Age between 18 to 45 years. * Both genders. * Blood tests (complete blood count, blood chemistry of three elements and liver function tests) within normal parameters specified by the reference laboratory with a lower and upper margin of 10%. * Vital signs within normal parameters. (Vital signs at rest: blood pressure ≤ 139/89 mmHg, heart rate 60 -100 beats per minute and respiratory rate of 12-24 breaths per minute). * Visual capacity 20/30 or better, in both eyes. * Intraocular pressure ≥11 and ≤ 21 mmHg. Exclusion Criteria: General criteria * Subjects with a history of hypersensitivity to any of the components of the research products. * Subject users of topical ophthalmic medications of any pharmacological group. * Subject users of medication by any other route of administration. * Pregnant or lactating women. * Women of childbearing age, who do not ensure a hormonal contraceptive method or intrauterine device during the study period or without a history of bilateral tubal obstruction, oophorectomy or hysterectomy; as fertile age we understand women who have not had their menopause, defined as 12 months since the last menstruation in women over 40 years. * Subjects with participation in clinical research studies 90 days prior to inclusion in the present study. * Diagnosis of liver disease or elevation to three times the normal upper value of any of the following liver enzymes: aspartate transferase (AST), alanine transferase (ALT) or bilirubin. * Inability to attend or answer the evaluations made in each of the visits. * Positive smoking (specified as cigarette consumption regardless of amount and frequency) * Positive alcoholism (specified as the consumption of alcoholic beverages, regardless of quantity and frequency, during the study intervention period). * Contact lens users. * An occlusive iridocorneal angle, defined as a trabecular mesh visible at less than 90 ° from the angular circumference to gonioscopy.

Outcomes

Primary Outcomes

Number of Adverse Events (EAS)

primary security variable the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent.

Time frame: during the 12 days of evaluation, including the safety call (day 12).

Ocular Burning (OB)

primary tolerability variable Ocular burning is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale: Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.