ISRCTN ISRCTN65886044
DOI https://doi.org/10.1186/ISRCTN65886044
IRAS number 347931
Secondary identifying numbers ID24-34
Submission date
16/10/2024
Registration date
23/10/2024
Last edited
23/10/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
In routine clinical practice, the measurement of contact lens visual performance is carried out using standard Snellen charts that present high-contrast letters (black letters on a white background) under photopic light conditions (good daytime lighting). The methodology lacks sensitivity to identify differences in visual performance between contact lenses which achieve very different levels of satisfaction. This study aims to test whether the difference in visual performance can be detected between a water-surface contact lens and a non-water-surface contact lens under testing conditions applicable to routine practice (high contrast high luminance visual acuity). Other aspects of interest will be to explore the sensitivity of letter contrast sensitivity and in vivo de-wetting kinetics measurements at detecting differences between water gradient and non-water gradient contact lenses

Who can participate?
Healthy volunteers aged between 18 and 75 years old who are current soft contact lens wearers and have low levels of astigmatism

What does the study involve?
The participant attends an initial screening, and enrolment fitting visit, followed by two test visits using two different contact lens types, one at each test visit at most seven days apart.

What are the possible benefits and risks of participating?
Participants have the opportunity to try contact lenses to correct their astigmatism.
Any contact lens wear comes at the risk of corneal infection, but the incidence rate is very low.

Where is the study run from?
Ocular Technology Group - International (OTG-i)

When is the study starting and how long is it expected to run for?
July 2023 to January 2025

Who is funding the study?
Alcon Research, LLC

Who is the main contact?
Deborah Moore, dmoore@otg.co.uk

Contact information

Miss Deborah Moore
Public

66 Buckingham Gate
London
SW1E 6AU
United Kingdom

Phone +44 (0)2072224224
Email dmoore@otg.co.uk
Dr Michel Guillon
Scientific, Principal Investigator

66 Buckingham Gate
London
SW1E 6AU
United Kingdom

Email mguillon@otg.co.uk

Study information

Study designDouble-masked prospective randomized cross-over study
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Other
Study typeEfficacy
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titleContact lens performance novel endpoints contact lens comparison
Study objectivesThe hypotheses to be tested is that high luminance high contrast Visual acuity achieved with the test contact lens material is different to that achieved with the control contact lens material.
Ethics approval(s)

Approved 16/09/2024, North East - Newcastle & North Tyneside 1 Research Ethics Committee (2nd Floor, 2 Redman Place Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8384; newcastlenorthtyneside1.rec@hra.nhs.uk), ref: 24/NE/0168

Health condition(s) or problem(s) studiedContact lens wettability
InterventionThis study is a double-masked prospective randomized cross-over study involving three study visits, an initial screening, and an enrolment fitting visit, followed by two test visits using two different CE-marked soft contact lens types (water-surface contact lens and non-water-surface contact lens). Computerised balance randomisation is used. The washout period is a minimum of 1 day between each treatment.

Following a visit in which potential participants are screened, enrolled and familiarised with the testing procedures, participants will visit the clinic on two separate days within 7 days and will complete tests to evaluate their vision and eye wettability at fixed time points.
Intervention typeDevice
Pharmaceutical study type(s)Not Applicable
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Water-surface contact lens, non-water-surface contact lens
Primary outcome measureMonocular static logMAR visual acuity high luminance (250 cd/m2), high contrast (>90%), distance (4 m) measured at each of the study visits
Secondary outcome measuresThe following secondary outcome measures will be assessed at each of the study visits:
1. Contact lens comfort measured using a 100-point visual analog scale
2. Visual performance for distance, intermediate and near distances measured using the OTG-i Vision Suite Landolt ring high luminance (250 cd/m2), distance (4 m), monocular timed control monocular contrast sensitivity test (3, 6, 12, 18 cycles per degree)
3. Pre-contact lens tear film measured using a tearscope over 30 seconds interblink period
Overall study start date01/07/2023
Completion date31/01/2025

Eligibility

Participant type(s)Healthy volunteer
Age groupMixed
Lower age limit18 Years
Upper age limit75 Years
SexBoth
Target number of participants25
Key inclusion criteria1. Aged from 18 to 75 years old
2. Current daily disposable hydrogel or silicone hydrogel spherical contact lens wearer to represent a normal contact lens-wearing population
3. Spectacle refraction: Distance: Sphere: -6.00D to + 2.00D; Astigmatism: 0.00D to -0.75
4. Best corrected visual acuity of at least 20/25 in each eye
Key exclusion criteria1. Habitual wearer of one of either of the two study contact lenses
2. Acute and subacute inflammation or infection of the anterior chamber of the eye
3. Any eye disease, injury or abnormality that affects the cornea, conjunctiva or eyelids that would contraindicate contact lens wear
4. Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic
5. Severe insufficiency of lacrimal secretion (dry eyes)
6. Any systemic disease that may affect the eye or may be exaggerated by wearing contact lenses (e.g. acne and eczema)
7. Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions
8. Any active corneal infection (bacterial, fungal, protozoal or viral)
9. Newly prescribed (within the past 30 days) use of some systemic medications (such as antihistamines, decongestants, diuretics, muscle relaxants, tranquillizers, stimulants, anti-depressants, anti-psychotics, oral contraceptives) or new prescription eyedrops which is not rewetting/lubricating eyedrops for which contact lens wear could be contraindicated as determined by the investigator
10. Monocular participants (only one eye with functional vision) or participants fit with only one contact lens
11. Subjects with slit lamp findings greater than grade 1 (e.g. edema, infiltrates, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival, anterior segment inflammation) as per ISO 11980, any previous history or signs of a contact lens related corneal inflammatory event (past corneal ulcers), or any other ocular abnormality that may contraindicate contact lens wear at the enrolment visit
12. History of corneal refractive surgery
13. Enrolment of the family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals
Date of first enrolment02/10/2024
Date of final enrolment31/12/2024

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Ocular Technology Group Ltd
66 Buckingham Gate
London
SW1E 6AU
United Kingdom

Sponsor information

Optometric Technology Group Ltd
Research organisation

66 Buckingham Gate
London
SW1E 6AU
England
United Kingdom

Email mguillon@otg.co.uk

Funders

Funder type

Industry

Alcon Research, LLC

No information available

Results and Publications

Intention to publish date31/12/2025
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planThere are no plans at this stage for publication or dissemination.
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date.

Editorial Notes

18/10/2024: Study's existence confirmed by Health Research Authority (HRA) (UK)