Safety and Tolerability of the Ophthalmic Gel PRO-167 Versus Corneregel® on Healthy Subjects.
Condition: Dry Eye; Dry Eye Syndrome of Unspecified Lacrimal Gland
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: PRO-167; Corneregel
Intervention description: Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.
Route of administration: ophthalmic; Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany. Route of administration: ophthalmic
Intervention MeSH terms: Pantothenic Acid
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: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: dry eye; eye lubricants; eye lubricant gel; PRO-167

Summary:

      Title of the study:

      Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic gel PRO-167
      versus Corneregel®, on the ocular surface of ophthalmological and clinically healthy
      subjects.

      Methodology:

      Phase I clinical trial, controlled, of parallel groups, double blind, randomized,
      exploratory.

      Goals:

      To evaluate the safety and tolerability of the ophthalmic gel PRO-167 manufactured by
      Laboratorios Sophia S.A. of C.V. on the ocular surface of clinically healthy subjects.

      Hypothesis:

      Ophthalmic gel PRO-167 has a safety and tolerability profile similar to that of its
      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.

          -  Visual capacity 20/30 or better, in both eyes.

          -  Intraocular pressure ≥11 and ≤ 21 mmHg.

        Exclusion 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.

          -  Women who are pregnant or breastfeeding.

          -  Women without a history of hysterectomy, oophorectomy, who do not ensure a hormonal
             contraceptive method or intrauterine device during the study period.

          -  Subjects with participation in clinical research studies 90 days prior to inclusion in
             the present study.

          -  Diagnosis of liver disease or triple 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 quantity and
             frequency)

          -  Positive alcoholism (specified as the consumption of alcoholic beverages, regardless
             of quantity and frequency, during the study intervention period)

          -  Contact lens users