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

NCT07559149 | Completed Phase 2 DMC

• 1 other identifier: KE/FK/1091/EC/2024
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CXL; Infected Corneal Ulcers

Outcome Measures

Primary Outcomes (1)

• Corneal Re-epithelialization

  The speed and percentage of the corneal surface healing

  Day 28 (week 4)

Secondary Outcomes (1)

• Pro-inflammatory Cytokine Levels

  Day before intervention (baseline), Day 7, Day 14, Day 28

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Patients receiving standard PACK-CXL therapy without the specialized amniotic membrane adjuvant

Other: Standard PACK-CXL

Riboflavin-Moxifloxacin Amniotic Membrane (Intervention Group)

EXPERIMENTAL

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

Interventions

Riboflavin-Moxifloxacin Amniotic Membrane COMBINATION_PRODUCT

Patients receiving PACK-CXL therapy with the addition of a specialized amniotic membrane containing 0.1% riboflavin and 0.5% moxifloxacin

Riboflavin-Moxifloxacin Amniotic Membrane (Intervention Group)

Standard PACK-CXL OTHER

Patients receive standard Photo-Activated Chromophore Keratitis-Corneal Cross-linking (PACK-CXL) therapy according to national clinical guidelines

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gadjah Mada University: lead

Study Sites (1)

Dr. Sardjito General Hospital

Sleman, Special Region of Yogyakarta, 55281, Indonesia

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist and Faculty Member

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 30, 2026
• Study Start: July 7, 2024
• Primary Completion: February 13, 2025
• Study Completion: August 14, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)