safety and tolerability of the ophthalmic gel pro-167 versus corneregel® on healthy subjects.

Conditions: Dry Eye; Dry Eye Syndrome of Unspecified Lacrimal Gland

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.

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.

Eligibility criteria:
inclusion criteria: * signed informed consent. * systemically and ophthalmologically healthy subjects evaluated during the clinical history. * age between 18 to 45 years. * both genders. * blood tests \[complete blood count, blood chemistry of three elements and liver function tests within normal parameters specified by the reference laboratory with a lower and upper margin of 10%. * vital signs within normal parameters. * visual capacity 20/30 or better, in both eyes. * intraocular pressure ≥11 and ≤ 21 mmhg. 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, 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) * contact lens users

Keywords: dry eye eye lubricants eye lubricant gel pro-167