drugset / Trial / NCT04702776

Study to Compare the Efficacy of the Ophthalmic Solution Humylub Ofteno® PF With Hyabak® and Lagricel Ofteno® PF as Treatment for Dry Eye.

NCT04702776

Phase 4 Completed 182 enrolled Laboratorios Sophia S.A de C.V.
RandomizedParallel-groupDouble-blindTreatment

Summary

Phase IV, non inferiority, controlled, open, multicenter clinical study to compare the efficacy of the Ophthalmic Solution Humylub Ofteno® PF against Hyabak® and Lagricel Ofteno® PF applied quater in die (QID) for 30 days in patients with mild to moderate dry eye disease.

Timeline

Start
2021-12-09
Primary completion
2023-05-15
Completion
2023-05-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Chondroitin sulfate Unknown 0.18 % Topical
Comparator Sodium Hyaluronate Other / unclassified 0.1 % Topical
Comparator Sodium Hyaluronate Other / unclassified 0.15 % Topical
Comparator Sodium Hyaluronate Other / unclassified 0.4 % Topical

Indications