Infected Corneal UlcersPhase 2NCT07559149
Effectiveness of Riboflavin-Moxifloxacin Amniotic Membrane as an Adjuvant for PACK-CXL in Moderate to Severe Infectious Keratitis
A Phase 2 study testing Riboflavin-Moxifloxacin Amniotic Membrane and Standard PACK-CXL in people with Infected Corneal Ulcers and CXL, run by Gadjah Mada University at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infected Corneal Ulcers, CXL
- What is being tested?
- Riboflavin-Moxifloxacin Amniotic Membrane and Standard PACK-CXL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIndonesia
- Study dates
- 7 Jul 2024to 14 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. Sardjito General Hospital
Sleman, Special Region of Yogyakarta, 55281
About this study
Official 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
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
- Infected Corneal Ulcers, CXL
- Being tested
- Riboflavin-Moxifloxacin Amniotic Membrane, Standard PACK-CXL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Riboflavin-Moxifloxacin Amniotic MembraneCombination product
Patients receiving PACK-CXL therapy with the addition of a specialized amniotic membrane containing 0.1% riboflavin and 0.5% moxifloxacin
Standard PACK-CXLOther
Patients receive standard Photo-Activated Chromophore Keratitis-Corneal Cross-linking (PACK-CXL) therapy according to national clinical guidelines
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Patients receiving standard PACK-CXL therapy without the specialized amniotic membrane adjuvant Receives: 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 Receives: Combination Product: Riboflavin-Moxifloxacin Amniotic Membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Re-epithelialization
The speed and percentage of the corneal surface healing
Measured: Day 28 (week 4)
Secondary outcomes (1)
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
Measured: Day before intervention (baseline), Day 7, Day 14, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start7 Jul 2024
- Primary completion13 Feb 2025
- Study completion14 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infected Corneal UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reny Setyowati, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559149
- Sponsor's protocol ID
- KE/FK/1091/EC/2024
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07559149
- Acronym / sponsor ID
- KE/FK/1091/EC/2024
- Conditions
- Infected Corneal Ulcers, CXL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 7 Jul 2024 (actual)
- Primary completion
- 13 Feb 2025 (actual)
- Study completion
- 14 Aug 2025 (actual)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Standard PACK-CXLPatients receiving standard PACK-CXL therapy without the specialized amniotic membrane adjuvant |
| Riboflavin-Moxifloxacin Amniotic Membrane (Intervention Group) | Experimental | Combination Product: Riboflavin-Moxifloxacin Amniotic MembranePatients receiving PACK-CXL therapy with the addition of a specialized amniotic membrane containing 0.1% riboflavin and 0.5% moxifloxacin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Riboflavin-Moxifloxacin Amniotic MembranePatients 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 (Intervention Group) |
| Standard PACK-CXLPatients receive standard Photo-Activated Chromophore Keratitis-Corneal Cross-linking (PACK-CXL) therapy according to national clinical guidelines | Other | Control Group |
Primary outcome
Corneal Re-epithelialization
Time frame: Day 28 (week 4)
The speed and percentage of the corneal surface healing
1 secondary outcome
Pro-inflammatory Cytokine Levels
Time frame: Day before intervention (baseline), Day 7, Day 14, Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No. 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
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Riboflavin-Moxifloxacin Amniotic Membrane and Standard PACK-CXL in people with Infected Corneal Ulcers and CXL, run by Gadjah Mada University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal Re-epithelialization (time frame: Day 28 (week 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.