Glaucoma Eye Diseases
Conditions
Interventions
One week prior to the baseline visit and whilst participating in the study the patients will be asked to complete a ‘drop compliance diary’ documenting when and how frequently they are using their gla
Sponsors
North West Anglia NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent signed and dated 2. Patients diagnosed with bilateral primary open-angle glaucoma (POAG) or ocular hypertension (OHT) 3. Patient aged =18 years old 4. Both eyes with a central corneal thickness of between 500-600 µm 5. Both eyes with a diagnosis of POAG or OHT, initially treated and controlled for at least six months by a prostaglandin analogue monotherapy (mane instillation) 6. IOP = 24 mmHg in at least one eye POAG 7. IOP = 30 mmHg in at least one eye OHT
Exclusion criteria
Exclusion criteria: 1. Fundus examination not performed or not available within 12 months 2. Visual field not performed or not available within 12 months 3. Advanced stage of glaucoma, defined by at least one of the following criteria: 4. Absolute defect in the ten degrees central point of the visual fields 5. Severe visual field loss: MD < -18 dB 6. Risk of visual field worsening as a consequence of participation in the study according to the investigator’s best judgment 7. Far best corrected visual acuity = +0.7 logMAR 8. History of trauma, infection, clinically significant inflammation within the previous three months 9. Ongoing or known history of ocular allergy and/or uveitis and/or viral infection 10. Clinically significant or progressive retinal disease (e.g. retinal degeneration, diabetic retinopathy, retinal detachment) 11. Conjunctival hyperaemia (Grade 5 - Efron scale) 12. Superficial punctate keratitis (Grade 4/5 – Oxford scale) 13. Blepharitis (Grade 3 – Efron scale) 14. Severe dry eye as assessed by the investigator 15. Corneal ulceration 16. Any palpebral abnormality incompatible with a good examination 17. Any other abnormality preventing accurate assessment e.g. reliable tonometry measurement, visual field examination, fundus examination. 18. A patient judged to have poor compliance with their glaucoma drops according to the investigator’s best judgement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ocular IOP measured in mmHg by Goldman and ORA at baseline, and then at five subsequent set time points during the day called ‘phasing’: 08:30 +/- 30 min, 10:30 +/- 30 min, 12:30 +/- 30 min, 14:30 +/- 30 min and 16:30 +/- 30 min. This same procedure will be repeated on visits one, two and three. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events that occur will be recorded at baseline and visits one, two and three 2. Quality of life measured using EQ-ED-5L and OSDI at baseline and visits one, two and three | — |
Countries
England, United Kingdom
Contacts
Public ContactOphthalmology Research Team
Outcome results
None listed