NCT04957329 Effect of Benzalkonium Chloride Preserved and Preservative-free Latanoprost Eye Drops on Conjunctival Goblet Cells
| NCT ID | NCT04957329 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Glaucoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2021-09-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 28 participants in total. It began in 2021-09-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Miriam Kolko, MD, PhD
PRINCIPAL INVESTIGATOR
Department of ophthalmology, rigshospitalet-Glostrup
Frequently Asked Questions
Who can join the NCT04957329 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glaucoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04957329 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04957329 currently recruiting?
Yes, NCT04957329 is actively recruiting participants. Contact the research team at anne.hedengran.nagstrup@regionh.dk for enrollment information.
Where is the NCT04957329 trial being conducted?
This trial is being conducted at Glostrup Municipality, Denmark, Copenhagen, Denmark.
Who is sponsoring the NCT04957329 clinical trial?
NCT04957329 is sponsored by Rigshospitalet, Denmark. The principal investigator is Miriam Kolko, MD, PhD at Department of ophthalmology, rigshospitalet-Glostrup. The trial plans to enroll 28 participants.