Use of Autologous Serum Eye-drops as Tears in Patients With Recalcitrant Dry Eye
This study has been completed.
Sponsor:
Singapore National Eye Centre
Information provided by (Responsible Party):
Louis Tong, Singapore National Eye Centre
ClinicalTrials.gov Identifier:
NCT01089985
First received: March 16, 2010
Last updated: January 15, 2012
Last verified: January 2012
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Purpose
The purpose of this study is to examine the efficacy and safety of autologous serum eye drops in people with recalcitrant dry eye.
| Condition | Intervention | Phase |
|---|---|---|
|
Xerophthalmia |
Drug: Autologous serum eyedrops |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Use of Autologous Serum Eye-drops as Tears in Patients With Recalcitrant Dry Eye |
Resource links provided by NLM:
Further study details as provided by Singapore National Eye Centre:
Primary Outcome Measures:
- Staining [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]Grading of punctate corneal staining in the worse eye (second visit relative to first visit)
Secondary Outcome Measures:
- Symptoms [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
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 .
- Tear-production [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]Schirmers test result
- Tear-proteins [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]Tear protein analysis
- Tear-stability [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]Tear break up time
- Cornea [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]other corneal findings such as scarring, vascularisation, filaments etc
- Conjunctiva [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]Documentation of conjunctival hyperemia, chemosis, scarring
| Enrollment: | 10 |
| Study Start Date: | July 2010 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Serum eye drops
Patient's autologous serum is diluted in saline solution
|
Drug: Autologous serum eyedrops
3 times a day for the duration of the study
|
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.
Eligibility| Ages Eligible for Study: | 21 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- HIV/HCV/HBV/syphilis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089985
Locations
| Singapore | |
| Singapore National Eye Centre | |
| Singapore, Singapore, 168571 | |
Sponsors and Collaborators
Singapore National Eye Centre
Investigators
| Principal Investigator: | Louis Tong, FRCS, MD | Singapore National Eye Centre |
| Principal Investigator: | Ronald Chung | Singapore National Eye Centre |
| Study Director: | Roger Beuerman | Singapore Eye Research Institute |
| Study Chair: | Mickey Koh | Singapore General Hospital |
| Study Chair: | Samanthila Waduthantri | Singapore National Eye Centre |
| Study Chair: | Heng Joo Ng | Singapore General Hospital |
| Study Chair: | Rohani Salleh | Singapore General Hospital |
More Information
No publications provided
| Responsible Party: | Louis Tong, Clinician-Scientist, Singapore National Eye Centre |
| ClinicalTrials.gov Identifier: | NCT01089985 History of Changes |
| Other Study ID Numbers: | R724/08/2010 |
| Study First Received: | March 16, 2010 |
| Last Updated: | January 15, 2012 |
| Health Authority: | Singapore: Health Sciences Authority |
Additional relevant MeSH terms:
|
Xerophthalmia Conjunctival Diseases Eye Diseases Dry Eye Syndromes Lacrimal Apparatus Diseases Tetrahydrozoline Nasal Decongestants Vasoconstrictor Agents |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Respiratory System Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013