Recurrent Corneal ErosionNCT01016158
Umbilical Cord Serum Eye Drops
A study testing Umbilical cord serum eyedrops in people with Recurrent Corneal Erosion, run by Chonnam National University Hospital at 1 site in South Korea.
Trial summary
In the present study, the investigators investigated the efficacy of umbilical cord serum eye drops for the treatment of patients with recurrent corneal erosions. Group A were treated with 20% umbilical cord serum eye drops 3 to 4 times a day in addition to artificial tears, and group B were treated with artificial… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Recurrent Corneal Erosion
- What is being tested?
- Umbilical cord serum eyedrops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2006to Oct 2009
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with recurrent corneal erosions
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
In the present study, the investigators investigated the efficacy of umbilical cord serum eye drops for the treatment of patients with recurrent corneal erosions. Group A were treated with 20% umbilical cord serum eye drops 3 to 4 times a day in addition to artificial tears, and group B were treated with artificial tears only. Ophthalmic examinations including visual acuity measurement and slit lamp biomicroscopy were performed before and every month after treatment. Recurrence was defined as the presence of clinical symptoms accompanied by epithelial defects in the cornea.
- Conditions
- Recurrent Corneal Erosion
- Being tested
- Umbilical cord serum eyedrops
- Keywords
- Umbilical cord serum, Recurrent corneal erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord serum eyedropsDrug
20% umbilical cord serum eye drops 3 to 4 times a day
| Study group | Role | What they receive |
|---|---|---|
| umbilical cord serum eyedrops | Experimental | patients with recurrent corneal erosions were treated with 20% umbilical cord serum eye drops 3 to 4 times a day in addition to artificial tears Receives: Drug: Umbilical cord serum eyedrops |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2009 (estimated)
- Study startApr 2006
- Primary completionApr 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Recurrent Corneal ErosionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016158
- Sponsor's protocol ID
- I-2009-11-135
- Status last verified
- Nov 2009
- First submitted
- 18 Nov 2009
- Last updated
- 19 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yoon KC, Im SK, Park YG, Jung YD, Yang SY, Choi J. Application of umbilical cord serum eyedrops for the treatment of dry eye syndrome. Cornea. 2006 Apr;25(3):268-72. doi: 10.1097/01.ico.0000183484.85636.b6.
PubMed 16633024del Castillo JM, de la Casa JM, Sardina RC, Fernandez RM, Feijoo JG, Gomez AC, Rodero MM, Sanchez JG. Treatment of recurrent corneal erosions using autologous serum. Cornea. 2002 Nov;21(8):781-3. doi: 10.1097/00003226-200211000-00010.
PubMed 12410036Yoon KC, You IC, Im SK, Jeong TS, Park YG, Choi J. Application of umbilical cord serum eyedrops for the treatment of neurotrophic keratitis. Ophthalmology. 2007 Sep;114(9):1637-42. doi: 10.1016/j.ophtha.2006.12.014. Epub 2007 Mar 26.
PubMed 17382396
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical Cord Serum Eye Drops
- ClinicalTrials.gov ID
- NCT01016158
- Acronym / sponsor ID
- I-2009-11-135
- Conditions
- Recurrent Corneal Erosion
- Keywords
- Umbilical cord serum, Recurrent corneal erosion
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 19 Nov 2009 (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.
In the present study, the investigators investigated the efficacy of umbilical cord serum eye drops for the treatment of patients with recurrent corneal erosions. Group A were treated with 20% umbilical cord serum eye drops 3 to 4 times a day in addition to artificial tears, and group B were treated with artificial tears only. Ophthalmic examinations including visual acuity measurement and slit lamp biomicroscopy were performed before and every month after treatment. Recurrence was defined as the presence of clinical symptoms accompanied by epithelial defects in the cornea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| umbilical cord serum eyedrops | Experimental | Drug: Umbilical cord serum eyedropspatients with recurrent corneal erosions were treated with 20% umbilical cord serum eye drops 3 to 4 times a day in addition to artificial tears |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with recurrent corneal erosions
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Umbilical cord serum eyedrops20% umbilical cord serum eye drops 3 to 4 times a day | Drug | umbilical cord serum eyedrops |
Primary outcome
Not reported in the source record.
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 19 Nov 2009.
- Results publication: PubMed 16633024Yoon KC, Im SK, Park YG, Jung YD, Yang SY, Choi J. Application of umbilical cord serum eyedrops for the treatment of dry eye syndrome. Cornea. 2006 Apr;25(3):268-72. doi: 10.1097/01.ico.0000183484.85636.b6.
- Results publication: PubMed 12410036del Castillo JM, de la Casa JM, Sardina RC, Fernandez RM, Feijoo JG, Gomez AC, Rodero MM, Sanchez JG. Treatment of recurrent corneal erosions using autologous serum. Cornea. 2002 Nov;21(8):781-3. doi: 10.1097/00003226-200211000-00010.
- Results publication: PubMed 17382396Yoon KC, You IC, Im SK, Jeong TS, Park YG, Choi J. Application of umbilical cord serum eyedrops for the treatment of neurotrophic keratitis. Ophthalmology. 2007 Sep;114(9):1637-42. doi: 10.1016/j.ophtha.2006.12.014. Epub 2007 Mar 26.
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 study testing Umbilical cord serum eyedrops in people with Recurrent Corneal Erosion, run by Chonnam National University Hospital at 1 site in South Korea.
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 1 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 19 Nov 2009. 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 South Korea. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01016158, which also lists 3 linked publications.
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 19 Nov 2009.