XerophthalmiaPhase 1NCT01089985
Use of Autologous Serum Eye-drops as Tears in Patients With Recalcitrant Dry Eye
A Phase 1 study testing Autologous serum eyedrops in people with Xerophthalmia, run by Singapore National Eye Centre at 1 site in Singapore.
Trial summary
The purpose of this study is to examine the efficacy and safety of autologous serum eye drops in people with recalcitrant dry eye. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Xerophthalmia
- What is being tested?
- Autologous serum eyedrops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2010to Dec 2011
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Seen at the dry eye service at the Singapore National Eye Centre
- Age between 21 and 75 years old
- Symptomatic for dry eye or VA worse than 6/12 in Snellen chart
- Presence of corneal punctate staining involving central zone
- Exhausted what is considered as standard therapy or therapy that is acceptable to the patient and the physician
- No contraindication for blood extraction/plasmapheresis
Who cannot join
- HIV/HCV/HBV/syphilis
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the efficacy and safety of autologous serum eye drops in people with recalcitrant dry eye.
Read the detailed description
A group of selected dry eye patients from the Singapore National Eye Centre who have exhausted the usual treatment options (lubricants, topical immunosuppressive and punctal occlusion) and not keen for tarsorrhaphy will be recruited. After informed consent, they will undergo plasmapheresis and start on daily autologous serum eyedrops for a period of 4 months. Clinical monitoring for standard dry eye parameters such as punctate corneal keratitis, Schirmers testing, tear break up time as well as severity and frequency of dry eye symptoms will be conducted. Tear inflammatory proteins captured on Schirmers paper pre and post treatment will be analysed as well.
- Conditions
- Xerophthalmia
- Being tested
- Autologous serum eyedrops
- Medical subject headings
- Xerophthalmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous serum eyedropsDrug
3 times a day for the duration of the study
| Study group | Role | What they receive |
|---|---|---|
| Serum eye drops | Experimental | Patient's autologous serum is diluted in saline solution Receives: Drug: Autologous serum eyedrops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Staining
Grading of punctate corneal staining in the worse eye (second visit relative to first visit)
Measured: 4 months
Secondary outcomes (6)
Symptoms
The change in Visual Analog Score (Schaumberg D et al Ocular Surface 2009). The global score is calculated from 2 scores, the frequency and severity of dry eye symptoms.
From .
Measured: 4 months
Tear-production
Schirmers test result
Measured: 4 months
Tear-proteins
Tear protein analysis
Measured: 4 months
Tear-stability
Tear break up time
Measured: 4 months
Cornea
other corneal findings such as scarring, vascularisation, filaments etc
Measured: 4 months
Conjunctiva
Documentation of conjunctival hyperemia, chemosis, scarring
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XerophthalmiaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Louis Tong, Singapore National Eye Centre
- Investigators
- Louis Tong, FRCS, MD, Principal investigator, Singapore National Eye CentreRonald Chung, Principal investigator, Singapore National Eye CentreRoger Beuerman, Study director, Singapore Eye Research InstituteMickey Koh, Study chair, Singapore General HospitalSamanthila Waduthantri, Study chair, Singapore National Eye CentreHeng Joo Ng, Study chair, Singapore General HospitalRohani Salleh, Study chair, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089985
- Sponsor's protocol ID
- R724/08/2010
- Status last verified
- Jan 2012
- First submitted
- 16 Mar 2010
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Autologous Serum Eye-drops as Tears in Patients With Recalcitrant Dry Eye
- ClinicalTrials.gov ID
- NCT01089985
- Acronym / sponsor ID
- R724/08/2010
- Conditions
- Xerophthalmia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Singapore National Eye CentreOther government
- Study start
- Jul 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 19 Mar 2010 (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 examine the efficacy and safety of autologous serum eye drops in people with recalcitrant dry eye.
Detailed description
A group of selected dry eye patients from the Singapore National Eye Centre who have exhausted the usual treatment options (lubricants, topical immunosuppressive and punctal occlusion) and not keen for tarsorrhaphy will be recruited. After informed consent, they will undergo plasmapheresis and start on daily autologous serum eyedrops for a period of 4 months. Clinical monitoring for standard dry eye parameters such as punctate corneal keratitis, Schirmers testing, tear break up time as well as severity and frequency of dry eye symptoms will be conducted. Tear inflammatory proteins captured on Schirmers paper pre and post treatment will be analysed as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serum eye drops | Experimental | Drug: Autologous serum eyedropsPatient's autologous serum is diluted in saline solution |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Seen at the dry eye service at the Singapore National Eye Centre
- Age between 21 and 75 years old
- Symptomatic for dry eye or VA worse than 6/12 in Snellen chart
- Presence of corneal punctate staining involving central zone
- Exhausted what is considered as standard therapy or therapy that is acceptable to the patient and the physician
Key exclusion criteria (1 listed)
- HIV/HCV/HBV/syphilis
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 |
|---|---|---|
| Autologous serum eyedrops3 times a day for the duration of the study | Drug | Serum eye drops |
Primary outcome
Staining
Time frame: 4 months
Grading of punctate corneal staining in the worse eye (second visit relative to first visit)
6 secondary outcomes
Symptoms
Time frame: 4 months
Tear-production
Time frame: 4 months
Tear-proteins
Time frame: 4 months
Tear-stability
Time frame: 4 months
Cornea
Time frame: 4 months
Conjunctiva
Time frame: 4 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 18 Jan 2012.
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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.
Louis Tong, FRCS, MD principal investigator
Singapore National Eye Centre
Ronald Chung principal investigator
Singapore National Eye Centre
Roger Beuerman study director
Singapore Eye Research Institute
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 Autologous serum eyedrops in people with Xerophthalmia, run by Singapore National Eye Centre at 1 site in Singapore.
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 6 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 18 Jan 2012. 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 Singapore. 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 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?
Staining (time frame: 4 months). 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 18 Jan 2012.