Overview

Effect of Benzalkonium Chloride Preserved and Preservative-free Latanoprost Eye Drops on Conjunctival Goblet Cells

Status:
Not yet recruiting
Trial end date:
2023-02-28
Target enrollment:
0
Participant gender:
All
Summary
a randomized, investigator-blind, interventinal study will compare the effect of benzalkonium-chloride (BAK) preserved and preservative-free (PF) eye drops on conjunctival goblet cells.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Rigshospitalet, Denmark
Collaborator:
Laboratoires Thea
Treatments:
Latanoprost
Criteria
Inclusion Criteria:

1. Age >18years

2. Danish speaking

3. Open angle glaucoma or ocular hypertension

4. Average intraocular pressure equal to or above 22 mmHg based on 3 measurements on each
eye

Exclusion Criteria:

1. history of significant eye diseae (including okular trauma) other than open angle
glaucoma and ocular hypertension

2. Pressure difference equal to or above 4 mmHg between eyes

3. corneal thickness <450μm or >600μm

4. treatment with steroids within the last 3 months from inclusion

5. Significant untreated systemic disease such as hypertension, heart failure, diabetes
mellitus, stroke, lung disease and autoimmune diseases. Diseases are not reason for
exclusion if they are well treated or does not need treatment

6. smoker at inclusion

7. pregnant or breast feeding

8. women using unsafe anticonception

9. allergy towards trial medication

10. patients who cannot cooperate in eye examination

11. ocular surface defects

12. need for polytherapy in glaucoma treatment