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

Dry Eye Clinical Trial

Official title: Phase I Clinical Study, to Evaluate the Safety and Tolerability of the Ophthalmic Gel PRO-167 Versus Corneregel®, on the Ocular Surface of Ophthalmological and Clinically Healthy Subjects.

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndrome of Unspecified Lacrimal Gland
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

• NCT number: NCT03520348
• Study type: Interventional
• Source: Laboratorios Sophia S.A de C.V.
• Status: Completed
• Phase: Phase 1
• Start date: October 4, 2017
• Completion date: July 16, 2018