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

Laboratorios Sophia

Status and phase

Completed

Phase 1

Conditions

Dry Eye

Dry Eye Syndrome of Unspecified Lacrimal Gland

Treatments

Drug: Corneregel

Drug: PRO-167

Study type

Interventional

Funder types

Industry

Identifiers

NCT03520348

SOPH167-0816/I

Details and patient eligibility

About

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.

Full description

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.

Enrollment

24 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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