Evaluation of Tear Characteristics Following TrueTear™ Use

• Research type

  Research Study

• Full title

  Clinical Study to Evaluate Tear Characteristics Following Acute TrueTear™ Use

• IRAS ID

  229413

• Contact name

  Kishan Patel

• Contact email

  kpatel@otg.co.uk

• Sponsor organisation

  Allergan (North America)

• Duration of Study in the UK

  0 years, 6 months, 30 days

• Research summary

  Studies have demonstrated that intranasal stimulation using the TrueTear device which delivers small electrical currents to the nostrils results in a significant increase in tear production measured by the Schirmer’s test and provides an option for treatment of Dry Eye disease. However, the duration of increased tear secretion after TrueTear use has not been quantified. Thus this study is aimed at quantifying both the tear volume change, duration of change of tear secretion and tear film stability and structure after using TrueTear device in dry eye sufferers.
  The study will be a single site study in UK involving 35 participants with moderate to severe dry eye symptomatology.
  The study will involve three clinic visits (screening, application#1, application#2) over a six week period. The 3 minutes applications (#1 or #2 will be randomized for test being inside the nostrils and control being outside the nostrils). Participants will receive both applications.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  17/NE/0232

• Date of REC Opinion

  21 Sep 2017

• REC opinion

  Further Information Favourable Opinion