Evaluation of ocular surface inflammation with glaucoma drops

• Research type

  Research Study

• Full title

  Evaluation of inflammatory markers in patients on topical anti-glaucoma drop therapy; a comparative trial of preserved and non-preserved primary medical treatment (eye drops) in patients with glaucoma and ocular hypertension – a pilot study.

• IRAS ID

  116234

• Contact name

  Anthony King

• Contact email

  anthony.king@nuh.nhs.uk

• Sponsor organisation

  Nottingham University NHS Trust

• Eudract number

  2013-000581-10

• Research summary

  Glaucoma is a chronic and potentially blinding condition resulting from raised intraocular pressure (IOP) in the eye. The majority of patients with glaucoma are treated with topical glaucoma drops which lower IOP and prevent disease progression.
  The commonly used eye drops contain a preservative which prolongs their safety by preventing infection of the drops once opened, however evidence is now available to demonstrate that the preservative component of these eye drops causes inflammation of the ocular surface. This inflammation has several consequences, firstly it causes ocular discomfort, irritation and redness all of which reduce adherence to eye drop usage and secondly low grade chronic inflammation increases the risk of surgery failure in patients who require surgery to treat their glaucoma.
  Recently a new preservative (polyquad) has replaced older preservative type (banzalkonium chloride) in some glaucoma drops and more drops have become available as preservative free preparations.
  It has been suggested that both polyquad and preservative free drops reduce ocular surface inflammation and the associated side effects. This is likely to improve patients symptoms, increase adherence and improve surgical outcomes.
  While evidence exists to demonstrate ocular surface inflammation associated with benzalkonium chloride no comparison has been made with polyquad or preservative free medications. In addition no studies have characterised the development of ocular surface inflammation in treatment naive patients.
  In this study we intend to randomise treatment naive subjects to drops preserved with benzalkonium chloride, polyquad or no presrevative to characterise the differences in ocular surface inflammation that develop with each of these treatments.
  We will take samples of tears and the surfcae cells of the ye and examinine them for markers of inflaammation. In patients we will take small tissue samples and also examine them for signs of inflammation. The study will be conducted over 24 months

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  13/EM/0225

• Date of REC Opinion

  25 Jul 2013

• REC opinion

  Further Information Favourable Opinion