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:~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.~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.
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.