PterygiumPhase 1NCT00155402
The Application of Fibrin Glue in Ocular Surface Diseases
A Phase 1 study testing tissue fibrin glue application (Tisseel) in people with Pterygium and Corneal Ulcer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This clinical trial tries to use tissue fibrin glues (Tisseel) to treat various ocular surface diseases or surgeries, which includes pterygium surgery, corneal melting/perforation, Gunderson's flap, conjunctival laceration, and muscle/clinical/filtering surgery. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Pterygium, Corneal Ulcer
- What is being tested?
- tissue fibrin glue application (Tisseel)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2005to Mar 2008
- Phase
- Phase 1
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ocular surface diseases, which are expected to be treated by tissue fibrin glues
Who cannot join
- Pregnancy
- Children younger than 3 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of Applying Fibrin Glue in Patients With Corneal Ulcer or Patients Requiring Wound Closure by Suture
This clinical trial tries to use tissue fibrin glues (Tisseel) to treat various ocular surface diseases or surgeries, which includes pterygium surgery, corneal melting/perforation, Gunderson's flap, conjunctival laceration, and muscle/clinical/filtering surgery.
Read the detailed description
This clinical trial tries to use tissue fibrin glues (Tisseel) to treat various ocular surface diseases or surgeries. The inclusion criteria are:
- ocular surface disease which may need amniotic membrane transplantation (corneal pro epithelization, pterygium surgery, etc)
- infectious or noninfectious corneal ulcer with perforation less than 3 mm
- conjunctival transplantation/suture
- corneal surgeries which can be treated by conventional suture technique or application with cyanoacrylic acid tissue glues.
Informed consents will be obtained from the patients before applications. After surgeries, topical steroids and antibiotics will be used, and therapeutic contact lens will be used. The patients will be followed up for at least three months.
- Conditions
- Pterygium, Corneal Ulcer
- Being tested
- tissue fibrin glue application (Tisseel)
- Keywords
- fibrin glue, corneal perforation, pterygium, conjunctiva, corneal ulcer
- Medical subject headings
- Pterygium, Corneal Ulcer, Corneal Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tissue fibrin glue application (Tisseel)Drug
Apply several droplets within several seconds to several minutes
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Use of fibrin glue after corneal surgery or transplantation Receives: Drug: tissue fibrin glue application (Tisseel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
cure of the diseases
Measured: 1week, 2 weeks, 3 weeks, 4 weeks
Secondary outcomes (2)
integrity of the ocular surface
Measured: 1week, 2 weeks, 3 weeks, 4 weeks
visual acuity
Measured: 1week, 2 weeks, 3 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startApr 2005
- Study completionMar 2008
Why it stopped: Short of supply of fibrin glue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PterygiumStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Fung-Rong Hu, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00155402
- Sponsor's protocol ID
- 940208
- Status last verified
- Mar 2005
- First submitted
- 8 Sep 2005
- Last updated
- 29 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Applying Fibrin Glue in Patients With Corneal Ulcer or Patients Requiring Wound Closure by Suture
- ClinicalTrials.gov ID
- NCT00155402
- Acronym / sponsor ID
- 940208
- Conditions
- Pterygium, Corneal Ulcer
- Keywords
- fibrin glue, corneal perforation, pterygium, conjunctiva, corneal ulcer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Short of supply of fibrin glue
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Mar 2008
- First posted
- 12 Sep 2005 (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.
This clinical trial tries to use tissue fibrin glues (Tisseel) to treat various ocular surface diseases or surgeries, which includes pterygium surgery, corneal melting/perforation, Gunderson's flap, conjunctival laceration, and muscle/clinical/filtering surgery.
Detailed description
This clinical trial tries to use tissue fibrin glues (Tisseel) to treat various ocular surface diseases or surgeries. The inclusion criteria are:
- ocular surface disease which may need amniotic membrane transplantation (corneal pro epithelization, pterygium surgery, etc)
- infectious or noninfectious corneal ulcer with perforation less than 3 mm
- conjunctival transplantation/suture
- corneal surgeries which can be treated by conventional suture technique or application with cyanoacrylic acid tissue glues.
Informed consents will be obtained from the patients before applications. After surgeries, topical steroids and antibiotics will be used, and therapeutic contact lens will be used. The patients will be followed up for at least three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: tissue fibrin glue application (Tisseel)Use of fibrin glue after corneal surgery or transplantation |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Ocular surface diseases, which are expected to be treated by tissue fibrin glues
Key exclusion criteria (2 listed)
- Pregnancy
- Children younger than 3 years old
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 |
|---|---|---|
| tissue fibrin glue application (Tisseel)Apply several droplets within several seconds to several minutes | Drug | 1 |
Primary outcome
cure of the diseases
Time frame: 1week, 2 weeks, 3 weeks, 4 weeks
2 secondary outcomes
integrity of the ocular surface
Time frame: 1week, 2 weeks, 3 weeks, 4 weeks
visual acuity
Time frame: 1week, 2 weeks, 3 weeks, 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2008.
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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.
Fung-Rong Hu, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing tissue fibrin glue application (Tisseel) in people with Pterygium and Corneal Ulcer, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 29 May 2008. 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 Taiwan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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?
cure of the diseases (time frame: 1week, 2 weeks, 3 weeks, 4 weeks). 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 29 May 2008.