Infectious KeratitisPhase 2NCT01831206
Collagen Cross-linking in Infectious Keratitis Trial
A Phase 2 study testing Collagen cross-linking in people with Infectious Keratitis and Bacterial Keratitis, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The purpose of this study is to evaluate the efficacy of collagen cross-linking for treatment of infectious keratitis. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Infectious Keratitis, Bacterial Keratitis, Fungal Keratitis
- What is being tested?
- Collagen cross-linking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2013to Dec 2014
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Evidence of corneal ulcer grade II or III (bacteria or fungal, or presumed bacterial or fungal)
- Age more than 6 year
- Patients can understand and can follow the study protocol
Who cannot join
- Pregnancy by history or urine test
- Evidence of herpetic keratitis
- Evidence of corneal perforation
- Evidence of autoimmune disease
- Known allergy to study medication
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Ophthalmology department, King Chulalongkorn Memorial hospital
Pratumwan, Bangkok, 10330
About this study
The purpose of this study is to evaluate the efficacy of collagen cross-linking for treatment of infectious keratitis.
- Conditions
- Infectious Keratitis, Bacterial Keratitis, Fungal Keratitis
- Being tested
- Collagen cross-linking
- Keywords
- corneal ulcer, keratitis
- Medical subject headings
- Corneal Ulcer, Keratitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen cross-linkingProcedure or surgery
Collagen cross-linking arm will receive standard medication for corneal ulcer treatment and corneal collagen cross-linking.
Standard treatment arm will receive only standard medication.
| Study group | Role | What they receive |
|---|---|---|
| Collagen cross-linking | Experimental | Collagen cross-linking with standard treatment Receives: Procedure: Collagen cross-linking |
| standard treatment | No intervention | Standard treatment alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
decrement of infiltration size
decrement of infiltration size between day0 and day 30
Measured: 1 months
Secondary outcomes (1)
number of participants with adverse events
adverse events after corneal collagen cross-linking (report in descriptive study)
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infectious KeratitisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ngamjit Kasetsuwan, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831206
- Sponsor's protocol ID
- 438/55
- Status last verified
- Apr 2013
- First submitted
- 6 Apr 2013
- Last updated
- 4 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.
PubMed 32557558
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collagen Cross-linking in Infectious Keratitis Trial
- ClinicalTrials.gov ID
- NCT01831206
- Acronym / sponsor ID
- 438/55
- Conditions
- Infectious Keratitis, Bacterial Keratitis, Fungal Keratitis
- Keywords
- corneal ulcer, keratitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Apr 2013 (estimated)
- 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.
The purpose of this study is to evaluate the efficacy of collagen cross-linking for treatment of infectious keratitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collagen cross-linking | Experimental | Procedure: Collagen cross-linkingCollagen cross-linking with standard treatment |
| standard treatment | No intervention | –Standard treatment alone |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Evidence of corneal ulcer grade II or III (bacteria or fungal, or presumed bacterial or fungal)
- Age more than 6 year
- Patients can understand and can follow the study protocol
Key exclusion criteria (5 listed)
- Pregnancy by history or urine test
- Evidence of herpetic keratitis
- Evidence of corneal perforation
- Evidence of autoimmune disease
- Known allergy to study medication
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 |
|---|---|---|
| Collagen cross-linkingCollagen cross-linking arm will receive standard medication for corneal ulcer treatment and corneal collagen cross-linking. Standard treatment arm will receive only standard medication. | Procedure or surgery | Collagen cross-linking |
Primary outcome
decrement of infiltration size
Time frame: 1 months
decrement of infiltration size between day0 and day 30
1 secondary outcome
number of participants with adverse events
Time frame: 1 months
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 4 May 2015.
- Derived from this study: PubMed 32557558Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.
Related trials for Infectious Keratitis
Recruiting
Intrastromal Moxifloxacin as an Adjunctive Therapy in Recalcitrant Bacterial Keratitis
Bacterial Keratitis, Recalcitrant Infectious Keratitis
Not yet recruitingPhase 3
RB-PDT for Fusarium Keratitis: The LUMIERE Study
Fusarium Keratitis
Active, not recruitingPhase 3
Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II
Bacterial Keratitis
RecruitingObservational study
Proteomic and Metabolomic Lacrimal Fingerprint in Diverse Pathologies of the Ocular Surface
Dry Eye Syndrome, Infectious Keratoconjunctivitis
Not yet recruiting
Effect of Sodium Chloride 5% Solution as an Adjuvant Treatment With Antimicrobial Therapy in the Treatment of Bacterial Infectious Keratitis
Infectious Keratitis, Adjuvant Treatment Bacterial Infectious Keratitis
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 Collagen cross-linking in people with Infectious Keratitis and Bacterial Keratitis, run by Chulalongkorn University at 1 site in Thailand.
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 3 inclusion and 5 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 4 May 2015. 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 Thailand. 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?
decrement of infiltration size (time frame: 1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01831206, which also lists 1 linked publication.
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 4 May 2015.