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Lagricel Ofteno PF vs Thealoz Duo for Corneal Re-epithelialization After PRK
NCT04704518Phase 4
Key facts
- Status
- Completed
- Start
- Sep 2022
- Primary completion
- Dec 2023
- Countries
- 1
- Sponsor
- Laboratorios Sophia
- Modality
- Polymer-based Nanoparticles, Small Molecules
- Drugs
- lagricel ofteno
- Conditions
- Corneal epithelial defect
01
Overview
Phase 4, randomised, open-label trial of lagricel ofteno in Corneal epithelial defect (2 arms), sponsored by Laboratorios Sophia. Primary endpoints: Changes in Corneal Re-epithelialization (Time) at Day 7 and Best Corrected Visual Acuity at Day 15. Started Sep 2022; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Group 1; Lagricel Ofteno PF
Lagricel Ofteno PF, multidose presentation (sodium hyaluronate 0.4%) Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.
Group 2; Thealoz Duo
Thealoz Duo, (trehalose 3%/sodium hyaluronate 0.15%). Ophthalmic Solution. One drop QID, both eyes (OU) for 14 days.
03
Who it enrols
Patients aged 18-45 on PRK postoperative day 1 with a surgical corneal ablation surface of 5.5 to 6.0 mm, PRK corneal output <= 60 um, and preoperative refraction of -1.0 to -4.5 D of myopia or myopic astigmatism.
04
Endpoints
Primary
Changes in Corneal Re-epithelialization (Time)
Best Corrected Visual Acuity
Secondary
Changes in Ocular Comfort Index
Pain Perception
Frequency of Pain Perception
Unexpected Adverse Events (AEs) Related to the Investigational Product
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