Glaucoma, Ocular Hypertension
Conditions
Brief 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.
Detailed description
The investigators will conduct a randomized, investigator-blind, interventinal study on 28 subjects. Each subject will apply a benzalkonium-chloride (BAK) preserved eye drop (Xalatan) in one eye and a preservative-free (PF) eye drop (Monoprost) in the other for 3 months. Which eye gets which treatment is randomized. Before and after treatment a conjunctival print will be made and the effect of the eye drops on goblet cell density will be evaluated along with effect on the intraocular pressure.
Sponsors
Laboratoires Thea
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
each subject will be treated with a BAK-preserved eye drop in one eye and PF-eye drops in the other eye for 3 months.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
a. history of significant eye diseae (including okular trauma) other than open angle glaucoma and ocular hypertension d. treatment with steroids within the last 3 months from inclusion e. 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 g. pregnant or breast feeding h. women using unsafe anticonception i. allergy towards trial medication j. patients who cannot cooperate in eye examination k. ocular surface defects l. need for polytherapy in glaucoma treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Goblet cell density | 3 months | Change in goblet cell density |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ocular surface disease index evaluation | 3 months | Change in OSDI |
| Intraocular pressure | 3 months | change in intraocular pressure |
| Ocular surface | 3 months | change in oxford scheme grading |
| Mucin content in tear film | 3 months | change in mucin concentration |
| Cytokines in tear film | 3 months | change in concentration of detectable interleukins e.g. interleukin 6 |
Countries
Denmark
Contacts
Primary ContactAnne Nagstrup, MD
Backup ContactMiriam Kolko, MD, PhD
Outcome results
None listed