Heat application to the eyelids to enhance ocular drug delivery

Not Applicable

• Conditions: Glaucoma; Eye Diseases

• Registration Number: ISRCTN22626706
• Lead Sponsor: orth West Anglia NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-27
• Last Update Posted: 13 May 2024
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 24

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified