An epidemiological study to compare adverse events associated with different formulations of latanoprost

Study type
Protocol
Date of Approval
Study reference ID
18_206
Lay Summary

Glaucoma is a condition where raised pressure inside the eye can cause reduced vision if left untreated. First treatment is normally with eye drops containing a drug called latanoprost, to reduce this pressure. This study is concerned with patients who have initially been prescribed latanoprost eye-drops by an ophthalmologist working in the NHS. The study will examine two different formulations of a latanoprost eye drops, one with a chemical preservative added and one without any preservative. Preservatives are designed to keep the medication sterile during patient use and the life cycle of the bottle but can be avoided if a sterile solution in a single-dose container is used. This study is concerned with the potential effect of the preservative on eye irritation and dryness. The aim of the study is to see if the preservative causes more eye irritation. Eye irritation that requires further treatment will be measured by hospital visits for specialist eye care and follow-up prescriptions for lubricants that are intended to reduce the effects of eye irritation. Any difference in these measures for the two formulations is likely to be due to potential eye irritation from the preservative. This study will inform appropriate prescribing of latanoprost for glaucoma.

Technical Summary

Retrospective cohort study comparing the differential risk of ophthalmology hospital referrals/episodes and coincident lubricant prescriptions in two cohorts of patients. The two cohorts are patients prescribed a) preservative-free formulations (Monopost-cohort 1) or b) preservative-containing formulations (latanoprost-cohort 2).The primary outcomes will be a) the annual rate of hospital referrals to ophthalmology and b) ophthalmology related hospital episodes for patients with linked Hospital Episode Statistics (HES) data. The secondary outcome is the rate of coincident lubricant eye drop prescribing in the two cohorts. As the two cohorts will be matched on age, gender and practice any observed differences are likely to be due to the preservative.

Health Outcomes to be Measured

Primary outcomes are hospital referrals from general practice to hospital ophthalmology and ophthalmology related hospital episodes as recorded in Hospital Episode Statistics. The secondary outcome is the rate of lubricant prescriptions in the study cohorts.

Collaborators

Martin Frisher - Chief Investigator - Keele University
Martin Frisher - Corresponding Applicant - Keele University
Nick Gibbons - Collaborator - Keele University
Stephen Chapman - Collaborator - Keele University

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation