NCT03520348

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Laboratorios Sophia S.A de C.V. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Dry Eye
• Dry Eye Syndrome of Unspecified Lacrimal Gland

Interventions

Type	Name	Description
DRUG	PRO-167	Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico. Route of administration: ophthalmic
DRUG	Corneregel	Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany. Route of administration: ophthalmic

Timeline

• Start date: 2017-10-04
• Primary completion: 2018-05-22
• Completion: 2018-07-16
• First posted: 2018-05-09
• Last updated: 2019-07-19
• Results posted: 2019-07-19

Locations

1 site across 1 country: Mexico