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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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BAK-preserved

Xalatan eye drop

Group Type ACTIVE_COMPARATOR

Xalatan

Intervention Type DRUG

Eye drop

Preservative-free

Monoprost eye drop

Group Type ACTIVE_COMPARATOR

Monoprost

Intervention Type DRUG

Eye drop

Interventions

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Xalatan

Eye drop

Intervention Type DRUG

Monoprost

Eye drop

Intervention Type DRUG

Other Intervention Names

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BAK-preserved latanoprost Preservative-free latanoprost

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No