CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 182 enrolled
Drug / intervention
Sodium hyaluronate 0.1%/chondroitin sulfate 0.18% +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04702776
NCT04702776Phase 4Completed
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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.

Laboratorios Sophia S.A de C.V.·interventional·Posted Jan 11, 2021·Updated Feb 20, 2026

In Brief

A Phase 4 clinical trial evaluating Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%, Sodium hyaluronate 0.15%, and 1 other intervention for Dry Eye. Completed, enrolled 182 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye
CountriesMexico
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedJan 11, 2021
Enrollment StartDec 9, 2021
Primary CompletionMay 15, 2023
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.5 years ago

Interventions

Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%drug

Application of one drop of Humylub Ofteno® PF (Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) QID in both eyes (OU) during 30 days.

Sodium hyaluronate 0.15%drug

Application of one drop of Hyabak® PF (Sodium hyaluronate 0.15%) QID in OU during 30 days.

Sodium hyaluronate 0.4%drug

Application of one drop of Lagricel Ofteno® PF (Sodium Hyaluronate 0.4%) QID in OU during 30 days.