drugset / Trial / NCT06822608

Evaluation of Dexpanthenol and Hyaluronic Acid Eye Drops on Corneal Epithelialization After Trans Epithelial PRK

NCT06822608

Phase 4 Not yet recruiting 68 enrolled National and Kapodistrian University of Athens
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The aim of this prospective, contralateral, randomized, double-blind, placebo-controlled study is the evaluation of the performance of a fixed combination of dexpanthenol and hyaluronic acid preservative-free eye artificial tears eye drops, in corneal wound healing after trans epithelial photorefractive keratectomy. One eye of each patient, randomly determined, will be assigned to receive artificial tears containing a combination of dexpanthenol-hyaluronic acid (study group) while the fellow eye will receive Placebo / identical combination containing the same ingredients and hyaluronic acid without dexpanthenol (control group). The drops will be applied hourly postoperatively, starting one hour after the surgery. All subjects will be treated until the day of complete reepithelialization or a maximum of 7 days postoperatively. Researchers will compare the epithelialization between the two eyes. The primary endpoint is the time to reepithelialization.The secondary endpoints are the intra-individual differences measured in each eye in terms of epithelial defect size in each visit, subjective evaluation of pain (discomfort) and subjective evaluation of vision.

Timeline

Start
2025-02
Primary completion
2025-11
Completion
2026-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexpanthenol Small molecule Topical
Comparator Hyaluronic Acid Other / unclassified Topical

Indications