Dry Eye Sjögren’s Syndrome Study with In-Clinic Omnigen

• Research type

  Research Study

• Full title

  A PROSPECTIVE, SINGLE CENTRE CASE SERIES INTO THE EFFICACY OF THE IN-CLINIC APPLICATION OF AMNIOTIC MEMBRANE (OMNIGEN®) IN REDUCING SIGNS AND SYMPTOMS OF DRY EYE DISEASE IN PATIENTS WITH SJÖGREN’S SYNDROME

• IRAS ID

  302224

• Contact name

  Anita Reynolds

• Contact email

  anita.reynolds@bthft.nhs.uk

• Sponsor organisation

  Bradford Teaching Hospitals NHS Foundation Trust

• Duration of Study in the UK

  0 years, 3 months, 1 days

• Research summary

  
  Background/Rationale-Dry eye disease (DED) is one of the most common ocular surface disorders worldwide.
  There are 2 subtypes evaporative and aqueous deficient which includes Sjögrens syndrome(SS).
  Cryopreserved amniotic membrane(CAM) has been used to treat DED,its short-term efficacy was attributed to its known potent anti-inflammatory, antifibrotic, and antiangiogenic properties in addition to its ability to enhance epithelial healing. There has been only one retrospective study so far which has used CAM (Prokera) for SS patients. Hence, in this study, we are prospectively reviewing a cohort of SS patients with DED to see effects of CAM.
  Study Design-A prospective, single centre case series studying the change of symptoms of DED in patients with diagnosed SS after in-clinic sutureless application of Omnigen®, through the use of OmniLenz®, a bespoke contact lens motif. Treatment will be for two five day periods with a 7 day break in between. Patients will continue their current medical management. The study will be conducted at Bradford Royal Infirmary eye clinic.
  Participants-Adult SS patients who have moderate-to-severe DED(grades 2–4), as defined by the Report of the International Dry Eye Workshop(DEWS). A total of 12 patients will be included so 24 eyes.
  Followup period-Day 0(Insertion of bilateral Omnigen/Omnilenz)
  Day 5(Removal of Omnigen/Omnilenz )
  Day 14(Insertion of second Omnigen/Omnilenz)
  Day 19(Removal of Omnigen/Omnilenz )
  4 weeks
  12 weeks
  Planned study period-4 months
  The objective is to assess if there has been any change in severity of DED symptoms in patients with SS following the treatment withOmnigen®.
  Primary outcome is change in Ocular surface disease indexOSDI score defined by DEWS at baseline and 12 weeks.
  Secondary outcome is change in OSDI score at baseline and 4 weeks. Secondary outcomes also include, best corrected visual acuity at baseline, 1 and 3 months, schirmer strip test at baseline, 1 and 3 months, conjunctival inflammation, corneal surface integrity, patient acceptability health utility at baseline and 12 weeks

• REC name

  London - Bromley Research Ethics Committee

• REC reference

  22/PR/0728

• Date of REC Opinion

  29 Jul 2022

• REC opinion

  Further Information Favourable Opinion