Last updated on May 2018

Safety and Tolerability of the PRO-174 Versus Sophix n Ofteno on the Ocular Surface of Healthy Subjects


Brief description of study

Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic solution PRO-174 versus Sophixn 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.

Detailed Study Description

Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic solution PRO-174 versus Sophixn 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.

Clinical Study Identifier: NCT03519516

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