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Completed

NCT Number: NCT01089985

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

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

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Key information

Conditions

Xerophthalmia Conjunctival Diseases Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Singapore National Eye Centre

Singapore, 168571

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous serum eyedrops

Drug

3 times a day for the duration of the study

Primary outcomes

  1. Staining

    Time frame: 4 months

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

Secondary outcomes

  1. Symptoms

    Time frame: 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

    Time frame: 4 months

    Schirmers test result

  3. Tear-proteins

    Time frame: 4 months

    Tear protein analysis

  4. Tear-stability

    Time frame: 4 months

    Tear break up time

  5. Cornea

    Time frame: 4 months

    other corneal findings such as scarring, vascularisation, filaments etc

  6. Conjunctiva

    Time frame: 4 months

    Documentation of conjunctival hyperemia, chemosis, scarring

Sponsors and collaborators

Lead sponsor

Singapore National Eye Centre

Other Gov

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 19, 2010
Registry last updated
Jan 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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