NCT04704518

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

Phase IV Clinical Study to Evaluate the Efficacy of Lagricel® Ofteno PF Compared to Thealoz® Duo for Corneal Re-epithelialization After Photorefractive Keratectomy (PRK)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Laboratorios Sophia S.A de C.V. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-09-03
• Primary completion: 2023-12-22
• Completion: 2023-12-22
• First posted: 2021-01-11
• Last updated: 2026-04-07
• Results posted: 2026-04-07

Locations

1 site across 1 country: Mexico