PresbyopiaNCT05734846

Multifocal Contact Lenses Fitting Methods Comparison

A study testing Test Lenses (test fitting approach) in people with Presbyopia, run by CooperVision, Inc. at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study was to compare the clinical performance of two fitting approaches for multifocal contact lenses. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Presbyopia
What is being tested?: Test Lenses (test fitting approach)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited Kingdom
Study dates: 11 Oct 2022to 1 Dec 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

At least 40 years old;
Have read and understood the Participant Information Sheet;
Have read, signed and dated the Informed Consent;
Best corrected visual acuity of at least 20/25 in each eye;
Have normal eyes with the exception of the need for visual correction;
Current multifocal contact lens wearer;

Show all 9Show fewer

Spectacle refraction:
Distance: Sphere: -6.00D to + 4.00D Astigmatism: 0.00D to -0.75D Near Addition: Established Presbyopes: +1.50D \& +1.75D
Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule.

Who cannot join

Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
Monocular participants (only one eye with functional vision) or participants fit with only one lens;
Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit;
History of herpetic keratitis, ocular surgery or irregular cornea;
Known pregnancy or lactation during the study period;
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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Ocular Technology Group - International
London, SW1E 6AU

Other trials in United Kingdom

About this study

Official title: Biofinity Multifocal Contact Lenses Fitting Methods Comparison

The purpose of this study was to compare the clinical performance of two fitting approaches for multifocal contact lenses.

Read the detailed description

This was a prospective, cross-over, double-masked (participants and investigator), randomized order of testing study. It compared two fitting approaches for silicone hydrogel multifocal contact lenses to assess which method achieved greater vision satisfaction and performance.

Conditions: Presbyopia
Being tested: Control Lenses (control fitting approach), Test Lenses (test fitting approach)
Medical subject headings: Presbyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Control Lenses (control fitting approach)Device
Daily wear multifocal lenses for 1 week
Test Lenses (test fitting approach)Device
Daily wear multifocal lenses for 1 week

Study groups in NCT05734846
Study group	Role	What they receive
Control Lenses, then Test Lenses	Experimental	Participants wore the Control Lenses for 1 week, then crossed over to the Test Lenses for 1 week. Receives: Device: Control Lenses (control fitting approach); Device: Test Lenses (test fitting approach)
Test Lenses, then Control Lens	Experimental	Participants wore the Test Lenses for 1 week, then crossed over to the Control Lenses for 1 week. Receives: Device: Control Lenses (control fitting approach); Device: Test Lenses (test fitting approach)

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Vision Satisfaction
Overall vision satisfaction for each lens was measured on a 0-100 point Visual Analog Scale (VAS), where 0=Extremely Unsatisfied and 100=Extremely Satisfied
Measured: One week
Overall Lens Preference
Participants selected their preferred lens fitting approach from options - 'Control', 'Test', or 'No Preference'
Measured: Two weeks

Secondary outcomes (2)

Overall Binocular Visual Acuity Index
Mean binocular visual performance for each lens was measured by timed logMAR charts. Overall binocular logMAR visual acuity index was calculated by taking the mean of distance and near visual acuities
Measured: One week
Number of Contact Lenses
This measured the ease of fitting each contact lens. It counted the number of contact lenses (pair), selected as per the fitting guide, used to determine the final contact lens to dispense.
Measured: One week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Oct 20221 Dec 2022

First posted21 Feb 2023
Study start11 Oct 2022
Primary completion1 Dec 2022
Study completion1 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PresbyopiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05734846
Sponsor's protocol ID: CV-22-49
Status last verified: Feb 2023
First submitted: 9 Feb 2023
Last updated: 10 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia

All Presbyopia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Biofinity Multifocal Contact Lenses Fitting Methods Comparison
ClinicalTrials.gov ID: NCT05734846
Acronym / sponsor ID: CV-22-49
Conditions: Presbyopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 11 Oct 2022 (actual)
Primary completion: 1 Dec 2022 (actual)
Study completion: 1 Dec 2022 (actual)
First posted: 21 Feb 2023 (actual)
Results: Posted 10 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study was to compare the clinical performance of two fitting approaches for multifocal contact lenses.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Control Lenses, then Test Lenses	Experimental	Device: Control Lenses (control fitting approach), Device: Test Lenses (test fitting approach)Participants wore the Control Lenses for 1 week, then crossed over to the Test Lenses for 1 week.
Test Lenses, then Control Lens	Experimental	Device: Control Lenses (control fitting approach), Device: Test Lenses (test fitting approach)Participants wore the Test Lenses for 1 week, then crossed over to the Control Lenses for 1 week.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

At least 40 years old;
Have read and understood the Participant Information Sheet;
Have read, signed and dated the Informed Consent;
Best corrected visual acuity of at least 20/25 in each eye;
Have normal eyes with the exception of the need for visual correction;

Key exclusion criteria (7 listed)

Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
Monocular participants (only one eye with functional vision) or participants fit with only one lens;
Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit;
History of herpetic keratitis, ocular surgery or irregular cornea;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Control Lenses (control fitting approach)Daily wear multifocal lenses for 1 week	Device	Control Lenses, then Test Lenses, Test Lenses, then Control Lens
Test Lenses (test fitting approach)Daily wear multifocal lenses for 1 week	Device	Control Lenses, then Test Lenses, Test Lenses, then Control Lens

Primary outcome

Overall Vision Satisfaction
Time frame: One week
Overall vision satisfaction for each lens was measured on a 0-100 point Visual Analog Scale (VAS), where 0=Extremely Unsatisfied and 100=Extremely Satisfied
Overall Lens Preference
Time frame: Two weeks
Participants selected their preferred lens fitting approach from options - 'Control', 'Test', or 'No Preference'

2 secondary outcomes

Overall Binocular Visual Acuity Index
Time frame: One week
Number of Contact Lenses
Time frame: One week

Results and safety

Results posted to the registry on 10 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Lenses, Then Test Lenses	13	13
Test Lenses, Then Control Lenses	12	12

Primary outcome: Overall Vision Satisfaction

Time frame: One week. Mean (Standard Deviation). Unit: score on a scale

Measure	Control Lenses n = 25	Test Lenses n = 25
Value	78.6 (18.3)	83.5 (14.9)

Primary outcome: Overall Lens Preference

Time frame: Two weeks. Count of participants. Unit: Participants

Measure	Contact Lens Overall Preference n = 25
Control Lenses	10
Test Lenses	11
No Preference	4

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Duration of the study, approximately 2 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Lenses	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Test Lenses	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Presbyopia

Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michel Guillon, PhD, FCOptom principal investigator

Ocular Technology Group - International

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Test Lenses (test fitting approach) in people with Presbyopia, run by CooperVision, Inc. at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Vision Satisfaction (time frame: One week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05734846.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.