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
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      Therapeutic indication:

      Corneal surface reepithelizing

      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
      quantitative variables. The difference between the qualitative variables will be analyzed by
      means of square chi (Chi2). An alpha ≤ 0.05 will be considered significant.

      Study period:

      3 to 4 months

      Development phase: I

      Number of patients:

      24 subjects, divided into 2 groups (12 eyes exposed per group)

      Test product, dose and route of administration, lot number:

      PRO-167. Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. de C.V.,
      Zapopan, Jalisco, Mexico.

        -  Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the
           bottom of the right eye sac.

        -  Route of administration: ophthalmic.

      Reference product, dose and route of administration, lot:

        -  Corneregel. Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin,
           Germany.

        -  Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the
           bottom of the right eye sac.

        -  Route of administration: ophthalmic

      Evaluation criteria:

      Primary security outcome variable:

      - Density of goblet cells.

      Secondary security variables:

        -  Epithelial defects in cornea and conjunctiva.

        -  Presence of adverse events.

      Secondary outcome variables:

        -  Intraocular pressure.

        -  Visual ability

        -  Break time of the tear film.

      Outcome variables of tolerability:

        -  Burning.

        -  Foreign body sensation.

        -  Itching.

        -  Eye comfort index.
    

Intervention name(s): PRO-167; Corneregel
Intervention type(s): Drug; Drug
Intervention description(s): 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
Other intervention name(s): dexpanthenol; dexpanthenol
Intervention MeSH terms: Pantothenic Acid
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: dry eye; eye lubricants; eye lubricant gel; PRO-167