AstigmatismNCT05933772

Performance Evaluation of Two Silicone Hydrogel Toric Lens Designs in Habitual Soft Contact Lens Wearers

A study testing Lens A (comfilcon A toric lens) and Lens B (lehfilcon A toric lens) in people with Astigmatism, run by CooperVision International Limited (CVIL) at 5 sites in 2 countries.

Completed

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

Official record

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Trial summary

The objective of the study was to compare the clinical performance of two monthly toric silicone hydrogel contact lenses in habitual wearers, when worn for 1-month each. Read more about this study

Who is it for?: Ages 18 to 39 yearsHealthy volunteers can take part
Conditions the study is for: Astigmatism
What is being tested?: Lens A (comfilcon A toric lens) and Lens B (lehfilcon A toric lens)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 5 sitesin 2 countries
Study dates: 18 Aug 2023to 28 Dec 2023
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 18 to 39 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Is between 18 and 39 years of age (inclusive) and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Self-reports having a full eye examination in the previous two years;
Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week;
Is willing and able to follow instructions and maintain the appointment schedule;
Habitually wears of toric soft contact lenses binocularly.

Show all 18Show fewer

No more than 1/3 of the participants should be wearing daily disposable soft toric lenses;
the remaining 2/3+ of the participants must be planned frequent replacement soft toric lens wearers as follows:
i. TOTAL30 for Astigmatism: maximum of 3 (∼10%) (no target percentage)
ii. Biofinity toric: maximum of 13 (∼40%) (PLUS a target of minimum 10 (∼30%))
iii. Air Optix for Astigmatism (inclusive of +Hydraglyde): maximum of 10 (∼30%) (PLUS a target of minimum 7 (∼20%))
iv. ULTRA for Astigmatism: maximum of 5 (∼15%) (no target percentage)
v. Acuvue Vita for Astigmatism: maximum of 3 (∼10%) (no target percentage)
vi. Acuvue Oasys for Astigmatism: maximum of 10 (∼30%) (no target percentage)
vii. Other brands of frequent replacement: maximum of 7 (∼20%) (no target percentage)
Has refractive astigmatism of at least -0.75DC but no more than -2.75DC in each eye that is correctable with a soft toric lens with a cylinder power of no greater than -2.25DC;
Is ammetropic and requires a spectacle spherical component of +8.00 to -10.00D inclusively;
Can be fit and achieve binocular distance vision of at least 20/32 Snellen with the available lens parameters

Who cannot join

Is participating in any concurrent clinical or research study;
Has any known active ocular disease and/or infection that contraindicates contact lens wear;
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
Has known sensitivity to the diagnostic sodium fluorescein used in the study;
Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
Has undergone refractive error surgery or intraocular surgery.

Trial locations and contacts

5 sites in 2 countries.

Country

City, postcode or hospital

5 sites in 2 countries

United States3 sites

ProCare Vision Center
Granville, Ohio, 43023
Kannarr Eye Care
Pittsburg, Kansas, 66762
Sacco Eye Group
Vestal, New York, 13850

Other trials in United States

Canada2 sites

Eyes on Sheppard Clinic
Toronto, Ontario, M2N 3A4
Spadina Optometry
Toronto, Ontario, M5V 3E7

Other trials in Canada

About this study

The objective of the study was to compare the clinical performance of two monthly toric silicone hydrogel contact lenses in habitual wearers, when worn for 1-month each.

Read the detailed description

This study was a prospective, bilateral eye, subjected-masked, randomized, 1-month cross-over, daily-wear design involving two different silicone hydrogel toric lens types. Each lens type will be worn bilaterally for approximately one month.

Conditions: Astigmatism
Being tested: Lens A (comfilcon A toric lens), Lens B (lehfilcon A toric lens)
Medical subject headings: Astigmatism

What participants receive

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

Lens A (comfilcon A toric lens)Device
One month wear
Lens B (lehfilcon A toric lens)Device
One month wear

Study groups in NCT05933772
Study group	Role	What they receive
Lens A, Then Lens B	Experimental	Participants will wear Lens A for one month and then crossover to Lens B for one month. Receives: Device: Lens A (comfilcon A toric lens); Device: Lens B (lehfilcon A toric lens)
Lens B, Then Lens A	Experimental	Participants will wear Lens B for one month and then crossover to Lens A for one month. Receives: Device: Lens A (comfilcon A toric lens); Device: Lens B (lehfilcon A toric lens)

What is being measured

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

Lens Handling on Removal
Lens Handling on Removal, using a 0-100 scale (0= very difficult, 100=very easy).
Measured: At the end of one month of wear

Secondary outcomes (1)

Distance Visual Acuity
Distance Visual Acuity, using Snellen converted to logMAR.
Measured: At the end of one month of wear

Timeline

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

18 Aug 202328 Dec 2023

First posted6 Jul 2023
Study start18 Aug 2023
Primary completion28 Dec 2023
Study completion28 Dec 2023

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 AstigmatismStudies 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: Single blind
Who is masked: Participant
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05933772
Sponsor's protocol ID: EX-MKTG-149
Status last verified: May 2023
First submitted: 28 Jun 2023
Last updated: 11 Mar 2025
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

Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
Astigmatism, Myopia
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism

All Astigmatism trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Performance Evaluation of Two Silicone Hydrogel Toric Lens Designs in Habitual Soft Contact Lens Wearers
ClinicalTrials.gov ID: NCT05933772
Acronym / sponsor ID: EX-MKTG-149
Conditions: Astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: CooperVision International Limited (CVIL)Industry (pharma, biotech, devices)
Collaborators: Centre for Ocular Research & Education, Canada
Study start: 18 Aug 2023 (actual)
Primary completion: 28 Dec 2023 (actual)
Study completion: 28 Dec 2023 (actual)
First posted: 6 Jul 2023 (actual)
Results: Posted 10 Mar 2025

Clinical summary

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

The objective of the study was to compare the clinical performance of two monthly toric silicone hydrogel contact lenses in habitual wearers, when worn for 1-month each.

Detailed description

Study design

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

Arm	Type	Receives
Lens A, Then Lens B	Experimental	Device: Lens A (comfilcon A toric lens), Device: Lens B (lehfilcon A toric lens)Participants will wear Lens A for one month and then crossover to Lens B for one month.
Lens B, Then Lens A	Experimental	Device: Lens A (comfilcon A toric lens), Device: Lens B (lehfilcon A toric lens)Participants will wear Lens B for one month and then crossover to Lens A for one month.

Who may qualify

Ages: 18 to 39 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (18 listed)

Is between 18 and 39 years of age (inclusive) and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Self-reports having a full eye examination in the previous two years;
Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week;
Is willing and able to follow instructions and maintain the appointment schedule;

Key exclusion criteria (7 listed)

Is participating in any concurrent clinical or research study;
Has any known active ocular disease and/or infection that contraindicates contact lens wear;
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
Has known sensitivity to the diagnostic sodium fluorescein used in the study;

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
Lens A (comfilcon A toric lens)One month wear	Device	Lens A, Then Lens B, Lens B, Then Lens A
Lens B (lehfilcon A toric lens)One month wear	Device	Lens A, Then Lens B, Lens B, Then Lens A

Primary outcome

Lens Handling on Removal
Time frame: At the end of one month of wear
Lens Handling on Removal, using a 0-100 scale (0= very difficult, 100=very easy).

1 secondary outcome

Distance Visual Acuity
Time frame: At the end of one month of wear

Results and safety

Results posted to the registry on 10 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lens A, Then Lens B	25	25
Lens B, Then Lens A	24	24

Primary outcome: Lens Handling on Removal

Time frame: At the end of one month of wear. Mean (Standard Deviation). Unit: units on a scale

Measure	Lens A n = 49	Lens B n = 49
Value	89 (17)	91 (14)

1 secondary outcome is reported in the full results.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Lens A	0 of 49 (0%)	5 of 49 (10.2%)	0 of 49
Lens B	0 of 49 (0%)	4 of 49 (8.2%)	0 of 49

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Astigmatism

Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
Astigmatism, Myopia
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism

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.

Andrew Sacco principal investigator

Sacco Eye Group

David Wilkinson principal investigator

Spadina Optometry

Fiona Soong principal investigator

Eyes on Sheppard Clinic

5 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Lens A (comfilcon A toric lens) and Lens B (lehfilcon A toric lens) in people with Astigmatism, run by CooperVision International Limited (CVIL) at 5 sites in 2 countries.

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 18 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 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Canada. 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 Mar 2025). 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?

Lens Handling on Removal (time frame: At the end of one month of wear). 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 NCT05933772.

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 11 Mar 2025.