drugset
drugset / Trial / NCT04704518

Study to Evaluate the Efficacy of Lagricel® Ofteno PF Compared to Thealoz® Duo After Photorefractive Keratectomy

NCT04704518 ↗

Phase 4 Completed 96 enrolled Laboratorios Sophia S.A de C.V.
RandomizedParallel-groupOpen-labelTreatment

Summary

Phase IV comparative, controlled, parallel group, open, randomized multicenter study to evaluate the efficacy of Lagricel® Ofteno PF Compared to Thealoz® Duo. Primary outcome measure is the time of corneal re-epithelialization after PRK surgery. Intervention includes administration of one of the experimental products quater per die (QID) for 14 days.

Timeline

Start
2022-09-03
Primary completion
2023-12-22
Completion
2023-12-22

Drugs

EvaluationDrugModalityDoseRoute
Comparator Sodium Hyaluronate Other / unclassified 0.15 % Topical
Comparator Sodium Hyaluronate Other / unclassified 0.4 % Topical
Comparator Trehalose Small molecule 3 % Topical

Indications

No indication recorded.