GlaucomaPhase 4NCT04957329
Effect of Benzalkonium Chloride Preserved and Preservative-free Latanoprost Eye Drops on Conjunctival Goblet Cells
A Phase 4 study testing Xalatan and Monoprost in people with Glaucoma and Ocular Hypertension, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- Xalatan and Monoprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Sep 2021to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18years
- Danish speaking
- Open angle glaucoma or ocular hypertension
- Average intraocular pressure equal to or above 22 mmHg
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Miriam Kolko, MD, PhD contact
Denmark2 sites, 2 recruiting
- Recruiting
Department of drug design and pharmacology, University of Copenhagen
Copenhagen, 2100
Anne Nagstrup, MD
Miriam Kolko, MD, PhD
- Not yet recruiting
Department of ophthalmology, rigshospitalet.glostrup
Glostrup Municipality, Danmark, 2600
Anne Nagstrup, MD, 22334504, anne.hedengran.nagstrup@regionh.dk
Miriam Kolko, MD, Phd, miriamk@sund.ku.dk
About this study
Official title: Department of Ophthalmology, Rigshospitalet-Glostrup Valdemar Hansens Vej 13, 2600 Glostrup, Denmark
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.
Read the 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.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- Xalatan, Monoprost
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XalatanDrug
Also called BAK-preserved latanoprost
Eye drop
MonoprostDrug
Also called Preservative-free latanoprost
Eye drop
| Study group | Role | What they receive |
|---|---|---|
| BAK-preserved | Active comparator | Xalatan eye drop Receives: Drug: Xalatan |
| Preservative-free | Active comparator | Monoprost eye drop Receives: Drug: Monoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goblet cell density
Change in goblet cell density
Measured: 3 months
Secondary outcomes (5)
Intraocular pressure
change in intraocular pressure
Measured: 3 months
Ocular surface
change in oxford scheme grading
Measured: 3 months
Mucin content in tear film
change in mucin concentration
Measured: 3 months
Cytokines in tear film
change in concentration of detectable interleukins e.g. interleukin 6
Measured: 3 months
Ocular surface disease index evaluation
Change in OSDI
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start1 Sep 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoires Thea
- Responsible party
- Principal investigator, Anne Hedengran Nagstrup, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Miriam Kolko, MD, PhD, Principal investigator, Department of ophthalmology, rigshospitalet-Glostrup
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957329
- Sponsor's protocol ID
- WP3
- Other IDs
- 2019-001642-18, 2019
- Status last verified
- Nov 2023
- First submitted
- 22 Jun 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Ophthalmology, Rigshospitalet-Glostrup Valdemar Hansens Vej 13, 2600 Glostrup, Denmark
- ClinicalTrials.gov ID
- NCT04957329
- Acronym / sponsor ID
- WP3
- Conditions
- Glaucoma, Ocular Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Laboratoires Thea
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| BAK-preserved | Active comparator | Drug: XalatanXalatan eye drop |
| Preservative-free | Active comparator | Drug: MonoprostMonoprost eye drop |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18years
- Danish speaking
- Open angle glaucoma or ocular hypertension
- Average intraocular pressure equal to or above 22 mmHg
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XalatanAlso: BAK-preserved latanoprostEye drop | Drug | BAK-preserved |
| MonoprostAlso: Preservative-free latanoprostEye drop | Drug | Preservative-free |
Primary outcome
Goblet cell density
Time frame: 3 months
Change in goblet cell density
5 secondary outcomes
Intraocular pressure
Time frame: 3 months
Ocular surface
Time frame: 3 months
Mucin content in tear film
Time frame: 3 months
Cytokines in tear film
Time frame: 3 months
Ocular surface disease index evaluation
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Miriam Kolko, MD, PhD contact
Miriam Kolko, MD, PhD principal investigator
Department of ophthalmology, rigshospitalet-Glostrup
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xalatan and Monoprost in people with Glaucoma and Ocular Hypertension, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Nagstrup, MD (+4522334504, anne.hedengran.nagstrup@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goblet cell density (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.