Safety and Tolerability of the PRO-174 Versus Sophixín Ofteno®, on the Ocular Surface of Healthy Subjects
Condition: Conjunctivitis; Conjunctivitis, Bacterial
MeSH terms: Conjunctivitis, Bacterial; Conjunctivitis
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): PRO-174; Sophixín Ofteno®
Intervention type(s): Drug; Drug
Intervention description(s): 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; 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
Other intervention name(s): PRO174; Levofloxacin Ophthalmic Solution; Ciprofloxacin Ophthalmic solution
Intervention MeSH terms: Ciprofloxacin; Levofloxacin; Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ocular antibiotic; quinolone; levofloxacin; ophthalmic antibiotic; antibiotic in drops