Condition category
Eye Diseases
Date applied
21/01/2019
Date assigned
23/01/2019
Last edited
23/01/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Multifocal contact lenses allow the wearers to see at all distances. For the best visual performance with multifocal contact lenses, typically one eye (the dominant one) will be fully corrected for distance vision and the other eye (non-dominant) will be biased towards intermediate and near vision. The aim of this study is to select the optimum lens power combinations for each eye to achieve the best distance and intermediate/near vision outcome with both eyes.

Who can participate?
Adults who are at least 40 years old and who have healthy eyes other than needing a near vision correction

What does the study involve?
Each participant has their eyes examined by the investigator and then fitted with two types of multifocal contact lenses according to their spectacle corrections and with additional plus or minus corrections in each eye. By reading letters of different sizes from various distances (far, intermediate and near), a series of vision measurements are taken with each of the pairs of multifocal contact lenses combination and corrections, and participant satisfaction is recorded on a 0-100 scale. All participants undergo the same series of vision tests and tasks.

What are the possible benefits and risks of participating?
Participants may not directly benefit from participation in this study. They may, however, contribute to research that may be used in the development of new, perhaps more successful, contact lenses. The examination and assessments are free and can be considered beneficial. All contact lenses have the potential of causing serious injury to the eye. Due to the nature and duration of the study the risks of participating in this study are considered to be similar to those of normal contact lens wear.

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

When is the study starting and how long is it expected to run for?
March 2017 to December 2017

Who is funding the study?
CooperVision, Inc. (USA)

Who is the main contact?
Ms Trisha Patel

Trial website

Contact information

Type

Public

Primary contact

Ms Trisha Patel

ORCID ID

Contact details

66 Buckingham Gate
London
SW1E 6AU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CV 17-20, OTGI 17-16

Study information

Scientific title

Multifocal contact lens combinations fitting method optimization

Acronym

Study hypothesis

The study is an exploratory study so no formal hypothesis is being formulated for the purpose of sample size calculation.

Ethics approval

Yorkshire & The Humber - Bradford Leeds Research Ethics Committee Jarrow Business Centre Rolling Mill Road, Jarrow, NE32 3DT, Tel: +44 (0)207 104 8081, Email: nrescommittee.yorkandhumber-bradfordleeds@nhs.net, 04/04/2017, REC ref: 17/YH/0115, IRAS 225847

Study design

Single-center prospective randomized (testing order) double masked and non-dispensing study

Primary study design

Observational

Secondary study design

Case crossover study

Trial setting

Other

Trial type

Screening

Patient information sheet

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

Condition

Presbyopia vision correction using multifocal contact lenses

Intervention

Multifocal contact lens fitting for dominant and non dominant eye based on best sphere spectacle correction and over-refractions. Visual performance will be measured using letter charts and visual satisfaction with each contact lens combination will be recorded. This is a non-dispensing study involving 1 or 2 study visits (if a break is required). Participants will wear 2 multifocal contact lens types and power combination.

Intervention type

Device

Phase

Drug names

Primary outcome measure

High contrast monocular and binocular visual acuities at distance (4 m), intermediate (67 cm) and near (40 cm) measured using letter charts in LogMAR during test visit

Secondary outcome measures

Visual satisfaction measured using visual analog scale (0-100) during test visit

Overall trial start date

13/03/2017

Overall trial end date

17/12/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

There are no requirements as to participant race, gender or occupation.
In order to be enrolled, each participant shall meet the following criteria:
1. At least 40 years old
2. Have read and understood the Participant Information Sheet
3. Have read, signed and dated the Informed Consent
4. Current multifocal contact lens wearer
5. Spectacle refraction:
Distance:
Sphere: -6.00D to + 6.00D
Astigmatism: 0.00D to -0.75D
Near Addition:
Low Add: +0.75D to +1.25D
Mid Add: +1.50D & +1.75D
High Add: +2.00D to +2.50D
6. Best corrected visual acuity of at least 20/30 in each eye
7. Have normal eyes with the exception of the need for visual correction
8. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

Up to 75 participants

Participant exclusion criteria

To be eligible as a participant, each candidate shall be free of any ocular or medical condition that may affect the results of this study.
The following are specific criteria that exclude a candidate from enrolment in this study:
1. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear
2. Use of systemic or ocular medications 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 contact 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
8. Participation in any clinical trial within 30 days of the enrolment visit

Recruitment start date

10/04/2017

Recruitment end date

01/06/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

CooperVision Inc. (USA)

Sponsor details

6150 Stoneridge Mall Rd
Pleasanton
CA 94588
United States of America

Sponsor type

Industry

Website

http://coopervision.com

Funders

Funder type

Industry

Funder name

CooperVision Inc. (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Since this study is an exploratory investigation designed to evaluate different optical designs and fitting approaches for multifocal contact lenses, there are no specific plans for publication or dissemination of the study results; however, an abstract for submission to an ophthalmic conference may be generated in which case the ISRCTN registration number would be provided.

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

30/06/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes