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Completed

NCT Number: NCT07559149

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

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.

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Key information

Conditions

Infected Corneal Ulcers CXL

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dr. Sardjito General Hospital

Sleman, Special Region of Yogyakarta, 55281, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Standard PACK-CXL

Other

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

Primary outcomes

  1. Corneal Re-epithelialization

    Time frame: Day 28 (week 4)

    The speed and percentage of the corneal surface healing

Secondary outcomes

  1. Pro-inflammatory Cytokine Levels

    Time frame: Day before intervention (baseline), Day 7, Day 14, Day 28

    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

Sponsors and collaborators

Lead sponsor

Gadjah Mada University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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