Effect of Benzalkonium Chloride Preserved and Preservative-free Latanoprost Eye Drops on Conjunctival Goblet Cells
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >18years
Danish speaking
Open angle glaucoma or ocular hypertension
Average intraocular pressure equal to or above 22 mmHg
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Xalatan
DrugEye drop
Monoprost
DrugEye drop
Treatment groups
28 Participants
are divided into 2 treatment groupsGroup A: BAK-preservedActive comparator 1 intervention
Group B: Preservative-freeActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Goblet cell density
Change in goblet cell density
Time frame
3 monthsSecondary outcomes
1
Intraocular pressure
change in intraocular pressure
Time frame
3 months2
Ocular surface
change in oxford scheme grading
Time frame
3 months3
Mucin content in tear film
change in mucin concentration
Time frame
3 months4
Cytokines in tear film
change in concentration of detectable interleukins e.g. interleukin 6
Time frame
3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rigshospitalet, Denmark
Lead sponsor
Laboratoires Thea
Collaborator
Source ClinicalTrials.gov