At a glance
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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.
In Brief
A Phase 1 clinical trial evaluating PRO-167 and Corneregel for Dry Eye and Dry Eye Syndrome of Unspecified Lacrimal Gland. Completed, enrolled 24 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico. Route of administration: ophthalmic
Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany. Route of administration: ophthalmic