Contact lens fitting characteristics study
| 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
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
Public
66 Buckingham Gate
London
SW1E 6AU
United Kingdom
| Phone | +44 (0)207 222 4224 |
|---|---|
| dmoore@otg.co.uk |
Study information
| Study design | Non dispensing prospective randomised (order of testing) cross over double-masked study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | The effect of contact lens parameters and material on fitting characteristics - pilot study |
| Study objectives | Mechanical 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) studied | Presbyopia multifocal contact lens fitting |
| Intervention | Each 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 type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not 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 measure | Contact lens decentration is measured from high speed video taken after 2 h of wear |
| Secondary outcome measures | Measured 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 date | 25/05/2020 |
| Completion date | 31/12/2020 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 15 |
| Key inclusion criteria | 1. 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 criteria | 1. 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 enrolment | 29/07/2020 |
| Date of final enrolment | 01/12/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
SW1E 6AU
United Kingdom
Sponsor information
Industry
6150 Stoneridge Mall Road
Pleasanton, CA
94588
United States of America
| Phone | +1 925 251 6682 |
|---|---|
| plazon@coopervision.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | There 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 plan | The 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
