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

Amniotic Membrane Preparation Containing Riboflavin and Moxifloxacin as Therapeutic Adjuvants for Photo-Activated Chromophore Keratitis- Corneal Cross-Linking (PACK-CXL): Materials Development, Preclinical, and Clinical Trials

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.

Study Overview

• Status: Completed
• Conditions: Infected Corneal Ulcers; CXL
• Intervention / Treatment: Other: Standard PACK-CXL; Combination product: Riboflavin-Moxifloxacin Amniotic Membrane

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• Indonesia
  • Special Region of Yogyakarta
    • Sleman, Special Region of Yogyakarta, Indonesia, 55281
      • Dr. Sardjito General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients diagnosed with moderate-to-severe infectious corneal ulcers (bacterial or fungal origin) by the Infection and Immunology subdivision at Dr. Sardjito General Hospital, Yogyakarta
• Patients scheduled to undergo Photo-Activated Chromophore Keratitis-Corneal Cross-linking (PACK-CXL) therapy
• Patients aged 18 years and older
• Patients willing to undergo PACK-CXL therapy
• Patients capable of providing informed consent and willing to participate in the entire study protocol

Exclusion Criteria:

• Patients who refuse follow-up examinations (tear film collection, corneal staining, or corneal scans) after the PACK-CXL procedure
• Patients with damaged or insufficient clinical specimens (e.g., tear samples) for laboratory analysis
• Patients unable to commit to the follow-up schedule

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Patients receiving standard PACK-CXL therapy without the specialized amniotic membrane adjuvant	Other: Standard PACK-CXL; Patients receive standard Photo-Activated Chromophore Keratitis-Corneal Cross-linking (PACK-CXL) therapy according to national clinical guidelines
Experimental: Riboflavin-Moxifloxacin Amniotic Membrane (Intervention Group); Patients receiving PACK-CXL therapy with the addition of a specialized amniotic membrane containing 0.1% riboflavin and 0.5% moxifloxacin	Combination product: Riboflavin-Moxifloxacin Amniotic Membrane; Patients receiving PACK-CXL therapy with the addition of a specialized amniotic membrane containing 0.1% riboflavin and 0.5% moxifloxacin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal Re-epithelialization	The speed and percentage of the corneal surface healing	Day 28 (week 4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pro-inflammatory Cytokine Levels	Measurement of IL-6, CXCL2, IL-1β, and IL-8 levels (pg/mL) in the corneal environment or tears to assess the reduction in inflammation	Day before intervention (baseline), Day 7, Day 14, Day 28

Collaborators and Investigators

• Sponsor: Gadjah Mada University

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2024
• Primary Completion (Actual): February 13, 2025
• Study Completion (Actual): August 14, 2025

Study Registration Dates

• First Submitted: April 23, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: KE/FK/1091/EC/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared to protect participant privacy and maintain confidentiality in accordance with the regulations of the local Medical and Health Research Ethics Committee

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No