Dry Eye SyndromeNCT00442273
Comparison of Autologous Serum and Umbilical Cord Serum Eyedrops for Dry Eye Syndrome
A study testing Umbilical cord serum eyedrops and Autologous serum eyedrops in people with Dry Eye Syndrome, run by Chonnam National University Hospital at 1 site in South Korea.
Trial summary
To compare the therapeutic effect between autologous serum and umbilical cord serum eyedrops in the treatment of severe dry eye syndrome. Read more about this study
- Who is it for?
- Ages 20 to 61 years
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- Umbilical cord serum eyedrops and Autologous serum eyedrops
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- Start not givento not given
- 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 20 to 61 years
- All sexes
- Adult
Who may be able to join
- Patients with severe dry eye syndrome who were refractory to conventional treatments and had symptoms of dry eye for more than 3 months
- Low tear film break-up time (BUT, < 5 sec)
- Low Schirmer test (5 mm)
- Positive fluorescein or rose bengal vital staining (≥ 3)
Who cannot join
- Active ocular infection or inflammation not associated with dry eye
- Contact lens wear
- Ocular allergy
- Ocular surgery within the recent 3 months
- Lid or lash abnormalities
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
To compare the therapeutic effect between autologous serum and umbilical cord serum eyedrops in the treatment of severe dry eye syndrome.
Read the detailed description
Ninety-two eyes of 48 patients with severe dry eye syndrome (34 eyes of 17 patients with Sjögren's syndrome and 58 eyes of 31 patients with non-Sjögren's syndrome) were treated with either 20% autologous serum (41 eyes of 21 patients) or umbilical cord serum eyedrops (51 eyes of 27 patients). Symptom scoring, corneal sensitivity test, tear film break-up time (BUT), Schirmer test, tear clearance rate (TCR), corneal fluorescein staining, and conjunctival impression cytology were performed before and 1 month and 2 months after treatment.
- Conditions
- Dry Eye Syndrome
- Being tested
- Umbilical cord serum eyedrops, Autologous serum eyedrops
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord serum eyedropsDrug
Autologous serum eyedropsDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kyung chul Yoon, M.D., Study director, Chonnam natianl university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442273
- Sponsor's protocol ID
- UCS-0001
- Status last verified
- Feb 2007
- First submitted
- 28 Feb 2007
- Last updated
- 1 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Autologous Serum and Umbilical Cord Serum Eyedrops for Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT00442273
- Acronym / sponsor ID
- UCS-0001
- Conditions
- Dry Eye Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- First posted
- 1 Mar 2007 (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.
To compare the therapeutic effect between autologous serum and umbilical cord serum eyedrops in the treatment of severe dry eye syndrome.
Detailed description
Ninety-two eyes of 48 patients with severe dry eye syndrome (34 eyes of 17 patients with Sjögren's syndrome and 58 eyes of 31 patients with non-Sjögren's syndrome) were treated with either 20% autologous serum (41 eyes of 21 patients) or umbilical cord serum eyedrops (51 eyes of 27 patients). Symptom scoring, corneal sensitivity test, tear film break-up time (BUT), Schirmer test, tear clearance rate (TCR), corneal fluorescein staining, and conjunctival impression cytology were performed before and 1 month and 2 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 61 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with severe dry eye syndrome who were refractory to conventional treatments and had symptoms of dry eye for more than 3 months
- Low tear film break-up time (BUT, < 5 sec)
- Low Schirmer test (5 mm)
- Positive fluorescein or rose bengal vital staining (≥ 3)
Key exclusion criteria (6 listed)
- Active ocular infection or inflammation not associated with dry eye
- Contact lens wear
- Ocular allergy
- Ocular surgery within the recent 3 months
- Lid or lash abnormalities
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 eyedrops | Drug | – |
| Autologous serum eyedrops | Drug | – |
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 1 Mar 2007.
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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.
Kyung chul Yoon, M.D. study director
Chonnam natianl university hospital
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 and Autologous serum eyedrops in people with Dry Eye Syndrome, 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 4 inclusion and 6 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 1 Mar 2007. 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?
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 1 Mar 2007.