drugset
drugset / Trial / NCT03697876

Safety and Tolerability of the Ophthalmic Gel PRO-165 Versus Artelac® Nightime Gel

NCT03697876 ↗

Phase 1 Completed 32 enrolled Laboratorios Sophia S.A de C.V.
RandomizedParallel-groupDouble-blindTreatment

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

Timeline

Start
2018-08-20
Primary completion
2024-06-26
Completion
2024-06-26

Drugs

EvaluationDrugModalityDoseRoute
Subject CARBOMER 910 Small molecule 0.2 % Other
Subject Chondroitin sulfate Unknown 0.18 % Other
Subject Sodium Hyaluronate Other / unclassified 0.2 % Other

Indications

dry eye syndrome