Use of Autologous Serum Eye-drops as Tears in Patients With Recalcitrant Dry Eye

• Sponsor: Singapore National Eye Centre (Other)
• Overall Status: Completed
• CT.gov ID: NCT01089985
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 17
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The purpose of this study is to examine the efficacy and safety of autologous serum eye drops in people with recalcitrant dry eye.

Condition or Disease	Intervention/Treatment	Phase
Xerophthalmia	Drug: Autologous serum eyedrops	Phase 1

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

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Use of Autologous Serum Eye-drops as Tears in Patients With Recalcitrant Dry Eye
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Staining [4 months]

   Grading of punctate corneal staining in the worse eye (second visit relative to first visit)

Secondary Outcome Measures

1. Symptoms [4 months]

   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 .

2. Tear-production [4 months]

   Schirmers test result

3. Tear-proteins [4 months]

   Tear protein analysis

4. Tear-stability [4 months]

   Tear break up time

5. Cornea [4 months]

   other corneal findings such as scarring, vascularisation, filaments etc

6. Conjunctiva [4 months]

   Documentation of conjunctival hyperemia, chemosis, scarring

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Louis Tong, Clinician-Scientist, Singapore National Eye Centre
• ClinicalTrials.gov Identifier: NCT01089985
• Other Study ID Numbers: R724/08/2010
• First Posted: Mar 19, 2010
• Last Update Posted: Jan 18, 2012
• Last Verified: Jan 1, 2012

• Additional relevant MeSH terms: Xerophthalmia; Ophthalmic Solutions

Study Results

No Results Posted as of Jan 18, 2012