Comparing the effects of two types of eye drops on eye health
Official title: Department of Ophthalmology, Rigshospitalet-Glostrup Valdemar Hansens Vej 13, 2600 Glostrup, Denmark
Run by Copenhagen University Hospital, Rigshospitalet · NCT04957329 · Data updated 2026-11-12
This study tests whether eye drops with preservatives or preservative-free eye drops are better for eye health in people with glaucoma or high eye pressure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 28 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Locations | 2 sites (Glostrup Municipality, Danmark and 1 other locations) |
| Status | Recruiting |
| Started | September 1, 2021 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | November 18, 2023 |
| Trial ID | NCT04957329 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are Danish-speaking adults over 18 years old with open-angle glaucoma or ocular hypertension and an average intraocular pressure of 22 mmHg or higher.
✕Probably not a fit
Patients with significant eye diseases other than glaucoma, those on steroid treatment, or individuals with untreated systemic diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the impact of benzalkonium-chloride preserved eye drops versus preservative-free eye drops on conjunctival goblet cells in patients with open-angle glaucoma or ocular hypertension. A total of 28 subjects will participate, applying one type of eye drop in each eye for three months. The study is randomized and investigator-blind, ensuring unbiased results. Before and after the treatment period, conjunctival prints will be taken to evaluate changes in goblet cell density and intraocular pressure.
Why it matters
Potential benefit: If successful, this study could lead to improved eye drop formulations that minimize damage to ocular surface cells, enhancing patient comfort and treatment outcomes.
How similar studies have gone: Previous studies have shown varying results regarding the effects of preservatives in eye drops, making this approach both relevant and necessary for further exploration.
Who can join: the full rules
Show full inclusion / exclusion 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 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
Where it's running
-
Department of drug design and pharmacology, University of Copenhagen
Copenhagen, Denmark Recruiting -
Department of ophthalmology, rigshospitalet.glostrup
Glostrup Municipality, Danmark, Denmark Not yet recruiting
Study contacts
- Principal investigator: Miriam Kolko, MD, PhD — Department of ophthalmology, rigshospitalet-Glostrup
- Study coordinator: Anne Nagstrup, MD
- Email: anne.hedengran.nagstrup@regionh.dk
- Phone: +4522334504
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.