safety and tolerability of pro-087 versus xyel ofteno® and systane ultra®, on the ocular surface of healthy subjects

Conditions: Dry Eye Syndromes; Lubricant Allergy; Tear Disorder

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.

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.

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.

Keywords: humylub pf artificial tears ophthalmic lubricant chondroitin sulfate sodium hyaluronate