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
Intervention: PRO-174; Sophixín Ofteno®
Intervention description: 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
Intervention MeSH terms: Ciprofloxacin; Levofloxacin; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
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)
Masking description: The blinding will correspond to the research subject and the principal investigator. In addition, the statistical analysis will be carried out in a blinded manner for the partial and final analysis.
The masking will be done using boxes in the primary packaging identical in the two groups. Blinding for the research subject and the researcher will be done by replacing the commercial labels in the case of the comparator in the bottles and the use of identical labels that contain the allocation number.
Blinding may be opened in the following cases:
Presence of a serious adverse event.
Safety alarm due to the use of the drugs under study.
In case the sponsor determines it for any reason of security or other reason that considers pertinent.
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ocular antibiotic; quinolone; levofloxacin; ophthalmic antibiotic; antibiotic in drops

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.
    

Eligibility criteria:

        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.