CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 96 enrolled
Drug / intervention
Sodium Hyaluronate Ophthalmic 0.4% +1 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/NCT04704518
NCT04704518Phase 4Completed
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Phase IV Clinical Study to Evaluate the Efficacy of Lagricel® Ofteno PF Compared to Thealoz® Duo for Corneal Re-epithelialization After Photorefractive Keratectomy (PRK)

Laboratorios Sophia S.A de C.V.·interventional·Posted Jan 11, 2021·Updated Apr 7, 2026

In Brief

A Phase 4 clinical trial evaluating Sodium Hyaluronate Ophthalmic 0.4% and Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15% for Photorefractive Keratectomy and Corneal De-epithelialization. Completed, enrolled 96 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPhotorefractive Keratectomy, Corneal De-epithelialization
CountriesMexico
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedJan 11, 2021
Enrollment StartSep 3, 2022
Primary CompletionDec 22, 2023
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 5.5 years ago

Interventions

Sodium Hyaluronate Ophthalmic 0.4%drug

Topical ophthalmic administration of one drop of Lagricel® Ofteno PF QID.

Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15%drug

Topical ophthalmic administration of one drop of Thealoz® Duo QID.