Safety and Tolerability of the Ophthalmic Gel PRO-167 Versus Corneregel® on Healthy Subjects.

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