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
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      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.

      Study period:

      3 to 4 months

      treatment duration: 10 days

      Number of patients:

      30 subjects, divided into 3 groups,10 subjects (20 eyes) exposed by group.

      Diagnosis and main 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, within normal parameters

        -  Visual capacity 20/30 or better

      Test product, dose and route of administration:

      - PRO-087. Chondroitin sulfate 0.18% / 0.1% sodium hyaluronate, ophthalmic solution
      preservative free. made by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.

      Dosage: 1 drop 4 times a day during the waking period, both eyes Route of administration:
      topical ophthalmic.

      Reference product, dose and route of administration:

        1. Xyel Ofteno®. Xanthan gum 0.09% / Chondroitin sulfate 0.1% / preservative-free
           ophthalmic solution. made by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco,
           Mexico.

           Dosage: 1 drop 4 times a day during the waking period, both eyes Route of
           administration: topical ophthalmic.

        2. Systane Ultra®. Polyethylene glycol 400 0.4%, propylene glycol 0.3%. made by Alcon
           Laboratories, Inc.

      Dosage: 1 drop 4 times a day during the waking period, both eyes Route of administration:
      topical ophthalmic.

      Evaluation criteria:

      Primary security outcome variables:

        -  Goblet cells density .

        -  Presence of adverse events.

        -  Intraocular pressure.

        -  Visual ability

        -  Laboratory tests

        -  Epithelial defects in cornea and conjunctiva.

        -  Ophthalmological signs: conjunctival hyperemia, chemosis.

      Secondary outcome variables:

        -  Tear film rupture time

        -  Life signs: heart rate, respiratory frequency systemic blood pressure.

        -  Subsequent segment

      Primary outcome variables of tolerability:

        -  Burning

        -  Foreign body sensation

        -  Itching

        -  Eye comfort index

      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 Kruskal-Wallis test for
      quantitative variables. The difference between the qualitative variables will be analyzed by
      means of chi square (Chi2). An alpha ≤ 0.05 will be considered significant.
    

Intervention name(s): PRO-087; Systane Ultra; Xyel Ofteno
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.
Other intervention name(s): chondroitin sulfate + sodium hyaluronate; Humylub PF; humylub preservative-free ophthalmic solution; humylub preservative-free ophthalmic solution PF; humylub preservative-free; humylub PF preservative-free; humylub PF ophthalmic solution; Polyethylene glycol 400 0.4%, propyleneglycol 0.3%; Xanthan gum 0.9 mg, sodium chondroitin sulfate
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions; Hyaluronic 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: Humylub PF; artificial tears; Ophthalmic lubricant; Chondroitin sulfate; Sodium hyaluronate