AstigmatismNCT04831515

Performance Evaluation of Two Daily Disposable Toric Lens Designs in Habitual Soft Contact Lens Wearers

A study testing Lens A and Lens B in people with Astigmatism, run by CooperVision, Inc. at 4 sites in United States.

Completed

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

Trial summary

The objective of the study is to compare the clinical performance of two different daily disposable, SiHy toric contact lens types, Lens A and Lens B, in existing soft lens wearers when worn for one week each. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Astigmatism
What is being tested?: Lens A and Lens B
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 4 sitesUnited States
Study dates: 29 Mar 2021to 2 Jul 2021
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Is at least 18 years of age 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 12 hours a day, 7 days a week;
Is willing and able to follow instructions and maintain the appointment schedule;
Habitually wears toric soft contact lenses binocularly, of any replacement frequency, for the past 3 months minimum;

Show all 10Show fewer

Has refractive astigmatism at least -0.75DC in each eye, maximum -2.25DC;
Has refractive cylinder axis either between 155 to 25 or between 65 and 115 degrees;
Is myopic and requires a spectacle spherical component of -1.00D to -6.50D inclusively;
Can be fit and achieve binocular distance vision of at least 20/30 Snellen with the available lens parameters

Who cannot join

Is participating in any concurrent clinical or research study;
Habitually wears one of the study contact lenses;
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

4 sites in 1 country.

United States4 sites

Athens Eye Care
Athens, Ohio, 45701
Golden Vision
Sarasota, Florida, 34237
Sacco Eye Group
Vestal, New York, 13850
Golden Optometric Group
Whittier, California, 90606

Other trials in United States

About this study

Read the detailed description

This study is a prospective, bilateral eye, double-masked, randomized, 1-week cross-over, daily-wear design involving two different daily disposable toric lens types. Each lens type will be worn for approximately one week, during which participants record their subjective lens-wear experience.

Conditions: Astigmatism
Being tested: Lens A, Lens B
Medical subject headings: Astigmatism

What participants receive

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

Lens ADevice
daily disposable soft contact lens - test lens
Lens BDevice
daily disposable soft contact lens - control lens

Study groups in NCT04831515
Study group	Role	What they receive
Lens A	Experimental	daily disposable soft contact lens - test lens Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week. Receives: Device: Lens A; Device: Lens B
Lens B	Active comparator	daily disposable soft contact lens - control lens Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week. Receives: Device: Lens A; Device: Lens B

What is being measured

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

Overall Ease of Lens Handling
Ease of overall lens handling for putting on eyes, removing from eyes, and opening packaging will be measured on a 0-10 integer scale (0=Very difficult, 10-Very easy)
Measured: 1 week

Secondary outcomes (2)

Visual Acuity
Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m)
Measured: Baseline - after lenses have settled for 10 minutes
Visual Acuity
Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m)
Measured: 1 week

Timeline

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

29 Mar 20212 Jul 2021

First posted5 Apr 2021
Study start29 Mar 2021
Primary completion2 Jul 2021
Study completion2 Jul 2021

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: Double blind
Who is masked: Participant, Investigator
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04831515
Sponsor's protocol ID: EX-MKTG-122
Status last verified: Feb 2022
First submitted: 1 Apr 2021
Last updated: 15 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
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 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Performance Evaluation of Two Daily Disposable Toric Lens Designs in Habitual Soft Contact Lens Wearers
ClinicalTrials.gov ID: NCT04831515
Acronym / sponsor ID: EX-MKTG-122
Conditions: Astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 29 Mar 2021 (actual)
Primary completion: 2 Jul 2021 (actual)
Study completion: 2 Jul 2021 (actual)
First posted: 5 Apr 2021 (actual)
Results: Posted 11 Feb 2022

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
Lens A	Experimental	Device: Lens A, Device: Lens Bdaily disposable soft contact lens - test lens Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week.
Lens B	Active comparator	Device: Lens A, Device: Lens Bdaily disposable soft contact lens - control lens Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Is at least 18 years of age 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 12 hours a day, 7 days a week;
Is willing and able to follow instructions and maintain the appointment schedule;

Key exclusion criteria (8 listed)

Is participating in any concurrent clinical or research study;
Habitually wears one of the study contact lenses;
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;

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 Adaily disposable soft contact lens - test lens	Device	Lens A, Lens B
Lens Bdaily disposable soft contact lens - control lens	Device	Lens A, Lens B

Primary outcome

Overall Ease of Lens Handling
Time frame: 1 week
Ease of overall lens handling for putting on eyes, removing from eyes, and opening packaging will be measured on a 0-10 integer scale (0=Very difficult, 10-Very easy)

2 secondary outcomes

Visual Acuity
Time frame: Baseline - after lenses have settled for 10 minutes
Visual Acuity
Time frame: 1 week

Results and safety

Results posted to the registry on 11 Feb 2022, 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	24	24
Lens B, Then Lens A	24	23

Primary outcome: Overall Ease of Lens Handling

Time frame: 1 week. Mean (Standard Deviation). Unit: units on a scale

Measure	Lens A n = 47	Lens B n = 47
Value	9.0 (1.1)	8.8 (1.5)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From dispense up to 1 week on each study lenses for a total of 2 weeks. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lens A	0 of 48 (0%)	0 of 48 (0%)	0 of 48
Lens B	0 of 48 (0%)	1 of 48 (2.1%)	0 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
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.

Lyndon Jones, PhD, FCOptom study director

Centre for Ocular Research and Education

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

Questions about this trial

What is this clinical trial studying?

A study testing Lens A and Lens B in people with Astigmatism, run by CooperVision, Inc. at 4 sites in United States.

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 10 inclusion and 8 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 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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 11 Feb 2022). 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 Ease of Lens Handling (time frame: 1 week). 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 NCT04831515.

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 15 Feb 2022.