The GOBLET trial: A clinical trial on GOblet cell density after Benzalkonium chloride and preservative-free Latanoprost Eye drop Treatment

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Rigshospitalet

Participant type

Healthy volunteers, Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

19 Mar 2024 → 4 Aug 2025

Decision date (initial)

2024-03-19

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-512275-12-00

EudraCT number

2019-001642-18

ClinicalTrials.gov

NCT04957329

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To compare goblet cell density when treating with a BAK-preserved and preservative-free latanoprost eye drops

Secondary objectives 4

1. To compare Intraocular pressure lowering efficacy of BAK-preserved and Preservative-free latanoprost eye drops
2. to compare difference in fluorescein and lissamine staining of the cornea and conjunctiva between treatment BAK-preserved and Preservative-free latanoprost eye drops
3. to compare mucin and cytokine concentration in tear film when treating with preservative-free and BAK-preserved latanoprost eye drops
4. to compare symptoms of dry eyes when treating with preservative-free and BAK-preserved latanoprost eye drops

Conditions and MedDRA coding

Ocular hypertension

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. age ≥18 years
2. IOP ≥ 22 mmHg on each eye measured by an opthalmologist
3. OHT or POAG
4. danish speaking

Exclusion criteria 8

1. History with significnat treatment required eye disease (including trauma) other than POAG or OHT
2. Need for multidrug glaucoma treatment
3. Ocular surface disease based on fluorescein staining at inklusion
4. Women not using safe contraception. The following contraception is accepted and shall be used under the entire study period: IUD or hormonal contraception (pill, implant, transdermal bandaid, vaginal ring or injektion). Sterile and non-fertile women do not need to use contraception. To be considered non-fertile or sterile a woman must be sterilized through surgery (Bilateral Tubal Ligation, hysterectomy or bilateral ovariectomy) or be postmenopausal (defined as at least 12 months since last period before inklusion). After completing the study there will be no need to follow up on fertile women regarding potential pregnancy as the study medication has poor systemic absorption and does not have a teratogen effect.
5. Pregnant or nursing. Pregnancy test will be performed on fertile women at inklusion
6. Treatment with systemic or lokal steroid within 3 months of study start g. Significant untreated systemic disease such as hypertension, heart failure, diabetes mellitus, stroke, lung disease and autoimmune disease. Diseases are acceptable if well-treated or if no treatment is required.
7. Known allergy towards active drug or additives in study medication.
8. Patients unable to coorperate

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. change in Goblet cell density

Secondary endpoints 4

1. Change in intraocular pressure
2. change in oxford score of fluorescein and lissamine staining of cornea and conjunctiva
3. change in conentration of mucin and cytokine concentration in tear film
4. Change in OSDI score

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rigshospitalet

Sponsor organisation

Rigshospitalet

Address

Valdemar Hansens Vej 1-23

City

Glostrup

Postcode

2600

Country

Denmark

Scientific contact point

Organisation

Rigshospitalet

Contact name

Miriam Kolko

Public contact point

Organisation

Rigshospitalet

Contact name

Miriam Kolko

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications