Safety and Tolerability of PRO-087 Versus Xyel Ofteno® and Systane Ultra®, on the Ocular Surface of Healthy Subjects
Condition: Dry Eye Syndromes; Lubricant Allergy; Tear Disorder
MeSH terms: Dry Eye Syndromes
Intervention: PRO-087; Systane Ultra; Xyel Ofteno
Intervention description: The intervention period consists of a therapy with PRO-087administered 4 times a day in the waking period for 10 days. with a security call to day 13.; The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13.; The intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13.
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions; Hyaluronic 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: Blinding It will consist in the elimination of the primary label (commercial) in the case of Xyel Ofteno® and Systane Ultra® and the placement of a label identical to the other interventions. Because the bottle in which Systane Ultra® is packaged differs in the color and shape of the lid used by Xyel Ofteno® and PRO-087, a masking will be carried out on the primary packaging which will be identical for the three interventions.The allocation sequence will be generated by personnel assigned. The research center will receive a set of envelopes which will contain the intervention number individually. The envelopes will be identical on the outside. Each of these envelopes will be shown to the participants for their election by the principal investigator or by a designated member of their team.
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 all analysis.
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Humylub PF; artificial tears; Ophthalmic lubricant; Chondroitin sulfate; Sodium hyaluronate

Summary:

      Phase I clinical study, to evaluate the safety and tolerability of the preservative-free
      ophthalmic solution PRO-087 versus Xyel Ofteno® and Systane Ultra®, on the ocular surface of
      ophthalmological and clinically healthy subjects.

      Objective: To evaluate the safety and tolerability of the preservative-free formulation
      PRO-087 manufactured by Laboratorios Sophia S.A. of C.V. on the ocular surface of clinically
      healthy subjects.

      Hypothesis:

      The ophthalmic solution PRO-087 presents a profile of safety and tolerability similar to
      comparators in healthy subjects

      Methodology:

      Phase I clinical trial, controlled, of parallel groups, double blind, randomized,
      exploratory.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Systemically and ophthalmologically healthy subjects

          -  Signed informed consent.

          -  Age between 18 to 40 years.

          -  Both genders

          -  Blood tests [complete blood count (BHC), three element blood chemistry (QS) and liver
             function tests (PFH)] within normal parameters

          -  Visual capacity 20/30 or better

        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 or hysterectomy, 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).

          -  Users of contact lenses.