NCT04957329

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_4

Timeline
8mo left

Started Sep 2021

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Sep 2021Dec 2026

First Submitted

Initial submission to the registry

June 22, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

5.3 years

First QC Date

June 22, 2021

Last Update Submit

November 15, 2023

Conditions

GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Goblet cell density

    Change in goblet cell density

    3 months

Secondary Outcomes (5)

  • Intraocular pressure

    3 months

  • Ocular surface

    3 months

  • Mucin content in tear film

    3 months

  • Cytokines in tear film

    3 months

  • Ocular surface disease index evaluation

    3 months

Study Arms (2)

BAK-preserved

ACTIVE COMPARATOR

Xalatan eye drop

Drug: Xalatan

Preservative-free

ACTIVE COMPARATOR

Monoprost eye drop

Drug: Monoprost

Interventions

XalatanDRUG

Eye drop

Also known as: BAK-preserved latanoprost
BAK-preserved
MonoprostDRUG

Eye drop

Also known as: Preservative-free latanoprost
Preservative-free

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18years
  • Danish speaking
  • Open angle glaucoma or ocular hypertension
  • Average intraocular pressure equal to or above 22 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of ophthalmology, rigshospitalet.glostrup

Glostrup Municipality, Danmark, 2600, Denmark

NOT YET RECRUITING

Department of drug design and pharmacology, University of Copenhagen

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Miriam Kolko, MD, PhD

    Department of ophthalmology, rigshospitalet-Glostrup

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Nagstrup, MD

CONTACT

+4522334504anne.hedengran.nagstrup@regionh.dk

Miriam Kolko, MD, PhD

CONTACT

miriamk@sund.ku.dk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of ophthalmology

Study Record Dates

First Submitted

June 22, 2021

First Posted

July 12, 2021

Study Start

September 1, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)