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

NCT04704518 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-04-07

Study results available
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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.

Conditions

  • Photorefractive Keratectomy
  • Corneal De-epithelialization

Interventions

DRUG

Sodium Hyaluronate Ophthalmic 0.4%

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

DRUG

Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15%

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

Sponsors & Collaborators

  • Laboratorios Sophia S.A de C.V.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Mexico

Study Locations

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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 NCT04704518 on ClinicalTrials.gov