ISRCTN ISRCTN16821484
DOI https://doi.org/10.1186/ISRCTN16821484
IRAS number 281961
Secondary identifying numbers CV20-42 ID20-17, IRAS 281961
Submission date
22/06/2020
Registration date
25/06/2020
Last edited
17/11/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
The shape of the edge of the contact lens influences the way the lens fits on the eye and its comfort. Different contact lenses have got different edges. The aim of the study is to compare how the lens fits on the eye along with its comfort for different multifocal contact lenses with different edge designs.

Who can participate?
Adults who are least 40 years old, who have healthy eyes, who wear contact lenses and are starting to get longsightedness (near addition +0.75 to +1.25).

What does the study involve?
A single visit during which the participant will use the 3 study contact lenses each for 2 hours.

What are the possible benefits and risks of participating?
The participants are current contact lens wearers and they will use under the control of the investigator the 3 currently marketed contact lenses. The risks to the participant are no greater than wearing their own contact lenses. The risks will be further minimised by the fact that the contact lenses will only be worn in the clinic under the supervision of the investigators. The possible benefit to the participant will be to try different contact lenses with different levels of comfort that they could eventually purchase from their own practitioner.

Where is the study run from?
Ocular Technology Group International (UK)

When is the study starting and how long is it expected to run for?
May 2020 to December 2020

Who is funding the study?
Cooper Vision Inc (USA)

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

Contact information

Mrs Deborah Moore
Public

66 Buckingham Gate
London
SW1E 6AU
United Kingdom

Phone +44 (0)207 222 4224
Email dmoore@otg.co.uk

Study information

Study designNon dispensing prospective randomised (order of testing) cross over double-masked study
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Other
Study typeOther
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleThe effect of contact lens parameters and material on fitting characteristics - pilot study
Study objectivesMechanical performance of contact lenses with a feather edge design is not inferior to that with a chisel edge design.
Ethics approval(s)Approved 04/05/2020, North West - Preston Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)207 104 8056; preston.rec@hra.nhs.uk), ref: 20/NW/020
Health condition(s) or problem(s) studiedPresbyopia multifocal contact lens fitting
InterventionEach participant uses all 3 contact lenses in a random order for a 2 hour period, after which the contact lens fitting measurement and comfort measurement are being carried out.

1. Measurement of contact lens decantation (horizontal and vertical) from the centre of the pull (mm). The measurement to be performed in primary gaze and reading gaze.
2. Lens centration and lens movement classification on 5 point scale.
3. Contact lens comfort rating on 100 point VAS scale.
Intervention typeDevice
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Clariti 1 day single vision contact lens Clariti 1 day multifocal low addition contact lens MyDay multifocal low addition contact lens
Primary outcome measureContact lens decentration is measured from high speed video taken after 2 h of wear
Secondary outcome measuresMeasured after 2 h of wear:
1. Lens centration rating on a 5 point scale by investigator using a slit lamp biomicroscope
2. Lens movement rating on a 5 point scale by investigator using a slit lamp biomicroscope
2. Comfort rating by participant using a computer based 100 point VAS scale
Overall study start date25/05/2020
Completion date31/12/2020

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexBoth
Target number of participants20
Total final enrolment15
Key inclusion criteria1. At least 40 years old
2. Have read and understood the Participant Information Sheet in English
3. Have read, signed and dated the Informed Consent
4. Best corrected visual acuity of at least 20/25 in each eye
5. Have normal eyes with the exception of the need for visual correction
6. Current contact lens wearer
7. Spectacle refraction:
Distance: Sphere: -6.00D to + 4.00D
Astigmatism: 0.00DC to -0.75DC
Near Addition: +0.75D to +1.25D
8. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule
Key exclusion criteria1. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear
2. Newly prescribed (within the past 30 days) use of some systemic medications (such as antihistamines, decongestants, diuretics, muscle relaxants, tranquilizers, 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
3. Monocular participants (only one eye with functional vision) or participants fit with only one lens
4. Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit
5. History of herpetic keratitis, ocular surgery or irregular cornea
6. Known pregnancy or lactation during the study period
7. Enrolment of the investigator or his/her staff, family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals
Date of first enrolment29/07/2020
Date of final enrolment01/12/2020

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

Cooper Vison Inc. (USA)
Industry

6150 Stoneridge Mall Road
Pleasanton, CA
94588
United States of America

Phone +1 925 251 6682
Email plazon@coopervision.com

Funders

Funder type

Industry

Cooper Vision (Inc) USA

No information available

Results and Publications

Intention to publish date31/12/2021
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planThere are no specific plans for publication or dissemination of the study results. However, an abstract for submission at an ophthalmic conference and/or a peer-reviewed publication may be generated.
IPD sharing planThe current data sharing plans for this study are unknown and will be available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Basic results version v0.3 27/10/2020 17/11/2020 No No

Additional files

ISRCTN16821484_BasicResults_v0.3_27Oct2020.docx
uploaded 17/11/2020

Editorial Notes

17/11/2020: The following changes were made to the trial record:
1. The basic results of this trial have been uploaded as an additional file.
2. The total final enrolment was added.
25/06/2020: Internal review.
23/06/2020: Trial’s existence confirmed by North West - Preston Research Ethics Committee