Self-measurement of eye pressure to determine daily fluctuations in patients using glaucoma eye drops

The study investigates the effect of two topical medications, both commonly used, for treatment of glaucoma. The therapeutic effect of the medications is to reduce intraocular pressure (IOP) however less understood is how they impact on IOP variation throughout the day. This study is designed to allow comparison of IOP measurements in patients treated with either topical prostaglandin analogue eye drops or beta blocker eye drops. Two groups of patients will be enrolled. For group 1, current treatment will serve as intervention treatment 1, alternative treatment as intervention treatment 2. Group 2 the two medications tested will be randomised into a intervention treatment 1 (weeks 2-3 of the below outlined protocol) and intervention treatment 2 (weeks 8-9 of the below outlined protocol). In all cases, medication will be adapted to patient needs based on widely accepted clinical protocols (titrated to effect based on 30% reduction in baseline IOP). Clinical effect and adherence will be assessed for safety reasons based on daily review of IOP measurements uploaded by the patient as outlined below. Medications administered as intervention treatments during this study are: Latanoprost (prostaglandin analogue): eye drop (solution) for reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. Timolol 0.25% (beta-blocker): eye drop (solution) for the reduction of elevated intraocular pressure. In clinical trials it has been shown to reduce intraocular pressure in: Patients with ocular hypertension and chronic open-angle glaucoma including aphakic patients. The measurement of IOP will be obtained with the Icare HOME instrument. Patients will be trained in the use of the ICARE HOME device, a procedure that takes less than five minutes per measurement. After turning the instrument on, the patient will need to load a single-use probe into the tonometer without touching it and briefly (1 second) press the measure button. Subsequently, the probe tip needs to be aligned with the centre of the cornea, preferentially in front of a mirror, by placing the forehead and cheek support in the respective positions as indicated by the eye care professional during training. If placed correctly, the probe base light will appear green. Pressing the measure button will allow the probe to collect a total of 6 measurements within a matter of seconds. Measurements should then be repeated in the other eye. Once finished, the patient should turn off the instrument by pushing the power button until three short beeps are heard and discard the used probe. • Training will take place in the clinic where the patient usually is seen for their eye health care. The training sessions will be arranged by the research team either via phone call or face-to-face following attendance at their usual eye care appointment. • Participants will undergo a 30-45-minute training session on how to use the instrument. Participants will have to demonstrate appropriate use of the instrument and pass an accreditation process (as outlined by the manufacturer). • For eyes that are successfully accredited, participants will be asked to measure IOP at four time points during the day in their habitual environment i.e. immediately upon awakening, before lunch, before dinner, and before going to bed. • Participants will also be trained in uploading their measurements to a cloud-based database (Icare Clinic) by connecting the instrument to an enabled device (e.g. phone with the application, Icare Export) Two patient groups will be recruited; each will have their respective timelines due to different baseline medication use. 1) Group 1: Patients who have been diagnosed with glaucoma or ocular hypertension who are already taking a topical medication to reduce intraocular pressure (prostaglandin analogue or beta-blocker) 2) Group 2: Patients with newly with diagnosed glaucoma or ocular hypertension who have been prescribed, but have not started using a topical medication (prostaglandin analogue or beta-blocker) Group 1: For patients already on topical anti-glaucoma medications • Week 1: Intervention treatment 1 (existing treatment serving as the comparator) • Week 2-5: Washout (no treatment) • Review Appointment: clinical assessment (including goldmann applanation IOP) • Week 6-7: Intervention treatment 2** • Final Appointment: clinical assessment and resumption of existing treatment **Alternative treatment represents a switch from their current medication to the other investigated eye drop. For example, if the patient’s existing medication was a prostaglandin analogue, the alternative treatment would be a beta-blocker & vice versa. Group 2: For patients who have not yet started topical anti-glaucoma medications. • Week 1: Baseline (without treatment) • Weeks 2-3: Intervention treatment 1(prostaglandin analogue or beta-blocker- randomly assigned***) • Review Appointment: clinical assessment (including goldmann applanation IOP) • Weeks 4 to 7***: Washout (no treatment): IOP is monitored remotely by the investigators. When IOP returns to baseline levels then the next step is initiated. • Telephone Call: An investigator will telephone the participant to advise commencement of intervention treatment • Weeks 8-9****: Intervention treatment 2 (alternative treatment to what was provided in Weeks 2-3) • Final Appointment: At study conclusion, patients will start treatment that was prescribed prior to baseline. *** Treatment protocol will be assigned using random number generator once for each participant. All even numbers will default to prostaglandin analogue in the first treatment round, uneven numbers to beta-blocker. ****The actual timing of these washout and treatment periods will be dependent on the time taken for IOP measurements to return to baseline.