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

Laboratorios Sophia

Status and phase

Completed

Phase 1

Conditions

Conjunctivitis

Conjunctivitis, Bacterial

Treatments

Drug: Sophixín Ofteno®

Drug: PRO-174

Study type

Interventional

Funder types

Industry

Identifiers

NCT03519516

SOPH174-0816/I

Details and patient eligibility

About

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.

Full description

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.

Enrollment

30 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.