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Phase I Clinical Study, to Evaluate the Safety and Tolerability of the Ophthalmic Gel PRO-165 Versus Artelac® Nightime Gel, on the Ocular Surface of Ophthalmological and Clinically Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating PRO-165 and Artelac for Dry Eye Syndromes. Completed, enrolled 32 participants across 1 site.
Detailed Summary
Objective: To assess the safety and tolerability of the PRO-165 formulation on the ocular surface of ophthalmologically and clinically healthy subjects. Hypothesis: Ophthalmic gel PRO-165 presents a safety and tolerability profile similar to Artelac® Nightime Gel in ophthalmological and clinically healthy subjects. Phase I clinical study, controlled, of parallel groups, double blind, randomized, exploratory Therapeutic indication of PRO-165: Eye lubricant
Study Details
Timeline
Interventions
PRO-165 Chondroitin sulfate 0.18% / sodium hyaluronate 0.2%, ophthalmic gel. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
Artelac® Nightime Gel. 0.2% Carbomer, ophthalmic gel. Made in Germany by: Dr. Gerhard Mann Chem Pharm. Imported and marketed by: Bausch \& Lomb México, S.A. de C.V.