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

 To evaluate the safety and tolerability of the formulation PRO-174 manufactured by
 Laboratorios Sophia, S.A. of C.V. on the ocular surface of clinically healthy subjects.

 Hypothesis:

 The ophthalmic solution PRO-174 presents a safety and tolerability profile similar to the
 comparator in healthy subjects.
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.
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.