NCT04702776

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

Non Inferiority Phase IV Clinical Study, to Compare the Efficacy of the Ophthalmic Solution Humylub Ofteno® PF Against Hyabak® and Lagricel Ofteno® PF When Applied on the Ocular Surface of Patients With Mild to Moderate Dry Eye.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Laboratorios Sophia S.A de C.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%	Application of one drop of Humylub Ofteno® PF (Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) QID in both eyes (OU) during 30 days.
DRUG	Sodium hyaluronate 0.15%	Application of one drop of Hyabak® PF (Sodium hyaluronate 0.15%) QID in OU during 30 days.
DRUG	Sodium hyaluronate 0.4%	Application of one drop of Lagricel Ofteno® PF (Sodium Hyaluronate 0.4%) QID in OU during 30 days.

Timeline

• Start date: 2021-12-09
• Primary completion: 2023-05-15
• Completion: 2023-05-15
• First posted: 2021-01-11
• Last updated: 2026-02-20
• Results posted: 2026-01-13

Locations

1 site across 1 country: Mexico