MedTrace Logo

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

NCT04702776 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2026-02-20

Study results available
· View outcomes & findings →

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

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.

Sponsors & Collaborators

  • Laboratorios Sophia S.A de C.V.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Mexico

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04702776 on ClinicalTrials.gov