drugset / Trial / NCT07559149

Effectiveness of Riboflavin-Moxifloxacin Amniotic Membrane as an Adjuvant for PACK-CXL in Moderate to Severe Infectious Keratitis

NCT07559149

Phase 2 Completed 32 enrolled Gadjah Mada University
RandomizedParallel-groupOpen-labelTreatment

Summary

This study aims to evaluate the effectiveness of a specialized amniotic membrane preparation as an adjuvant therapy for patients with moderate-to-severe infected corneal ulcers. The specialized membrane contains a combination of Riboflavin and Moxifloxacin, which is applied during Photo-Activated Chromophore Keratitis-Corneal Cross-linking (PACK-CXL) therapy. The researchers compare this new approach with the standard PACK-CXL procedure to see if it improves corneal healing (re-epithelialization) and reduces inflammation markers. The study was conducted in a randomized controlled trial format at Dr. Sardjito General Hospital, Yogyakarta.

Timeline

Start
2024-07-07
Primary completion
2025-02-13
Completion
2025-08-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Moxifloxacin Small molecule 0.5 %
Subject Riboflavin Other / unclassified 0.1 %

Indications