Treating discharge and discomfort of eye prosthesis: a comparison between vitamin A ointment, anti-inflammatory eye drops and standard eye drops

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amsterdam UMC

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

29 Feb 2024 → 14 Sep 2024

Decision date (initial)

2023-09-09

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

UitZicht

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

This study aims to test the effect of artificial tears, vitamin A ointment and steroid drops in artificial eye wearers with chronic complaints of irritation and/or excess discharge.

Secondary objectives 1

1. The second objective is to define the patients that may benefit from a specific regimen.

Conditions and MedDRA coding

Chronic mucopurulent discharge and/or discomfort of the ocular prosthesis socket

Regulatory references

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Patients wearing an ocular prosthesis and Excess mucopurulent discharge and/or discomfort

Exclusion criteria 1

1. - Subjects < 16 years old - Subjects expected to be incapable to understand the study or fill-out the questionnaires. - Patients with treatable acquired medical issues of the socket (ie new conjunctival cyst, exposed implant). If the patients still have mucopurulent discharge and discomfort after removal/treatment of the irritative factor, they can be included. - Patients with transient complaints from suspected (sub) acute infections for which antibiotics are prescribed. If the patients still have mucopurulent discharge and discomfort after treatment, they can be included. - Patients with scratched, or irregular prostheses, or with latest polishing more than one year ago, should first have their prosthesis polished or renewed. If the patients still have mucopurulent discharge and discomfort after these improvements than they can be included. - The model of the prosthesis should first be adapted if a wrong fit is suspected (ie large empty space, pressure points). If the patients still have mucopurulent discharge and discomfort after these improvements than they can be included.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change of discomfort score and discharge score and discharge score from baseline till 2-week use of either: Artificial eyedrops, topical vitamin A ointment or low-dose topical steroids

Secondary endpoints 1

1. We also attempt to characterize the patients who will benefit from either artificial eyedrops, topical vitamin A ointemnt of low-dose steroids

Investigational products

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

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amsterdam UMC

Sponsor organisation

Amsterdam UMC

Address

De Boelelaan 1117

City

Amsterdam

Postcode

1081 HV

Country

Netherlands

Scientific contact point

Organisation

Amsterdam UMC

Contact name

Arthur Liu

Public contact point

Organisation

Amsterdam UMC

Contact name

Arthur Liu

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

Application history

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