Condition category
Eye Diseases
Date applied
25/10/2017
Date assigned
31/10/2017
Last edited
31/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Floaters are moving shapes that people see floating in their vision. They can look like dots, shadows, clouds or strands. Floaters are usually harmless and don’t impact vision. However, when they move into our line of vision, they can interfere with many everyday tasks such as reading or driving. As floaters results from changes to the vitreous (a clear, jelly-like fluid in the eye), an intervention with food supplementation comprising of water-soluble antioxidants (molecules that stop oxidation), modulators of the glycation of collagens, and inhibitors of connective tissue degrading enzymes are an option to treat them. The food supplement "VitroCap NEM" could be used to help treat floaters. The aim of this study is to investigate if the food supplement VitroCap NEM can reduce visual disturbances in the vitreous.

Who can participate?
Patients aged 18 and older who have floaters in their eyes.

What does the study involve?
Participants are randomly allocated to one of two groups. One of these groups will receive the placebo capsule to taken daily by mouth for six months. The other group will receive the VitroCap NEM capsules (containing specially prepared from grape seeds and citrus fruits as well as vitamins) to take daily by mouth for six months. Participants are followed up at six months to assess the change in vitreous floater disturbances.

What are the possible benefits and risks of participating?
Participants may benefit from the treatment. There are no direct risks to volunteers participating in this research. We will inform the participant’s doctor that they will be participating in our research study.

Where is the study run from?
NOW-Science Consultancy Limited (Ireland)

When is the study starting and how long is it expected to run for?
January 2017 to January 2019

Who is funding the study?
ebiga-VISION GmbH (Germany)

Who is the main contact?
Professor John Nolan

Trial website

Contact information

Type

Scientific

Primary contact

Prof John Nolan

ORCID ID

Contact details

Carriganore House
Waterford Institute of Technology
West Campus
Carriganore
Waterford
X91 K236
Ireland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

FLIES Version 1

Study information

Scientific title

Floater Intervention Study (FLIES)

Acronym

FLIES

Study hypothesis

The aim of the study is to investigate if supplementation with VitroCap NEM reduces visual disturbances associated with the degeneration of the vitreous body of the eye (i.e. eye floaters disturbances).

Ethics approval

Research Ethics Committee, HSE, South East, Ireland, 24/04/2017

Study design

Single-centre double-blind placebo-controlled randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Vitreous floaters

Intervention

60 participants are randomised in a 50:50 masked fashion to either active ingredient (VitroCap NEM) or placebo. Block randomisation is performed using a trial management system “Trial Controller” designed by our research group.

Active group: Participants are given VitroCap NEM capsules (containing specially prepared plant ingredients from grape seeds and citrus fruits as well as vitamin C, the amino acid L-lysine, and zinc) to take daily for a total period of 6 months.
VitroCap NEM exact contents are as follows:
1. 125 mg of L-lysine
2. 40 mg of vitamin C
3. 25 mg of Vitis vinifera extract (procyanidines)
4. 5 mg of zinc
5. 60 mg of Citrus aurantinium flavonoids

Placebo group: Participants are given placebo capsules to take daily for a total period of 6 months.

Participants in both groups are asked to attend study visits at baseline and 6-months.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

Change in floater disturbance is measured using a subjective questionnaire following 6 months of intervention. This will be achieved by comparing the difference in change of floater-related disturbance in participants on the active intervention versus participants on the placebo intervention.

Secondary outcome measures

1. Visual function is measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) logarithm of the minimum angle of resolution (LogMAR) chart (Test Chart 2000 PRO™) for Best-corrected visual acuity (BCVA); the LogMAR EDTRS (Test Chart 2000 PRO™) for Letter Contrast Sensitivity (CS); the “Advanced Vision and Optometric Tests” (AVOT) for visual acuity, contrast sensitivity, cone and rod vision; MultiQuity (MiQ) test Suite for visual acuity and contrast sensitivity at baseline and 6-months
2. Macular pigment is measured using dual-wavelength autoflourescence, a video of floaters are captured using Scanning Laser Ophthalmoscopy (SLO) and retinal layers are measured using Optical Coherence Tomography (OCT). All outcomes listed use the Spectralis HRA + OCT Multicolour, Heidelberg at baseline and 6-months
3. Colour fundus photographs are captured using a Zeiss Visucam at baseline and 6-months
4. Reaction time is measured using the Cognition tests the Cambridge Neuropsychological Test Automated Battery (CANTAB) at baseline and 6-months
5. Blood samples are taken to measure sodium, potassium, chloride, urea, creatinine, bilirubin, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma-glutamyl transferase, total protein, albumin, globulin, calcium, magnesium, phosphate, uric acid, vitamin C, glucose, highly sensitive C-reactive protein, and full blood count concentrations at baseline and 6-months

Overall trial start date

02/01/2017

Overall trial end date

31/01/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients who report primary floaters to their ophthalmologist
2. 18 years and older

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. No secondary floaters (e.g. haemorrhage)
2. Any doctor diagnosis of retinal pathology (e.g. glaucoma, age-related macular degeneration, macular oedema, retinal detachment or scars)
3. Laser eye surgery or vitrectomy performed or scheduled in the duration of the study
4. Pregnancy
5. Alcohol or drug abuse
6. Legal incompetence or restricted legal capacity
7. Cataract surgery scheduled within the duration of this trial
8. Refractive error greater than -3D
9. Axial length longer than 25mm

Recruitment start date

24/10/2017

Recruitment end date

31/01/2018

Locations

Countries of recruitment

Ireland

Trial participating centre

NOW-Science Consultancy Limited
Waterford
X91 K236
Ireland

Sponsor information

Organisation

NOW-Science Consultancy Limited

Sponsor details

C/O Carriganore House
WIT West Campus
Waterford
X91 K236
Ireland

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

ebiga-VISION GmbH

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publications in a high-impact peer reviewed journal expected to be published.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/01/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes