AstigmatismNCT05020990

The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses

A study testing Lens A (delefilcon A) and Lens B (stenfilcon A) in people with Astigmatism, run by CooperVision, Inc. at 3 sites in United Kingdom.

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

This study aimed to compare the clinical performance of two daily disposable toric contact lenses. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Astigmatism
What is being tested?: Lens A (delefilcon A) and Lens B (stenfilcon A)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 3 sitesUnited Kingdom
Study dates: 1 Apr 2022to 2 May 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

They are at least 18 years old and have the capacity to volunteer.
They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
They are willing and able to follow the protocol.
They currently wear soft contact lenses or have done so in the past two years.
They have a spherical component of their contact lens prescription between Plano to - 6.00DS (inclusive).
They have a cylindrical component of their contact lens prescription between -0.75DC and -2.50DC (inclusive).

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They can be satisfactorily fitted with the study lens types.
At dispensing, they could attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
They own a wearable pair of spectacles.
They agree not to participate in other clinical research while enrolled on this study.

Who cannot join

They have an ocular disorder which would normally contra-indicate contact lens wear.
They have a systemic disorder, which would normally contra-indicate contact lens wear.
They are using any topical medication such as eye drops or ointment.
They are aphakic.
They have had corneal refractive surgery.
They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.

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They are pregnant or breastfeeding.
They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
They have eye or health conditions including immunosuppressive or infectious diseases, which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
They are currently wearing one of the study contact lenses.
They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Trial locations and contacts

3 sites in 1 country.

United Kingdom3 sites

Cameron Optometry
Edinburgh, Edinburg, EH3 6SW
Phipps Opticians
Heckmondwike, WF16 0EZ
Simon Falk Eyecare
Oakwood, Leeds, LS8 2HU

Other trials in United Kingdom

About this study

This study aimed to compare the clinical performance of two daily disposable toric contact lenses.

Read the detailed description

This was a multi-center, randomized, participant-masked, bilateral study controlled by cross-comparison. Participants were assigned to either lens type in random sequence. Lenses were worn on a daily disposable wear schedule. Follow-up visits for each lens were performed after 1 week of wear.

Conditions: Astigmatism
Being tested: Lens A (delefilcon A), Lens B (stenfilcon A)
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 (delefilcon A)Device
Daily disposable for one week
Lens B (stenfilcon A)Device
Daily disposable for one week

Study groups in NCT05020990
Study group	Role	What they receive
Lens A, then Lens B	Experimental	Participants wore Lens A for one week, then crossed over to wear Lens B for one week. Receives: Device: Lens A (delefilcon A); Device: Lens B (stenfilcon A)
Lens B, then Lens A	Experimental	Participants wore Lens B for one week, then crossed over to wear Lens A for one week. Receives: Device: Lens A (delefilcon A); Device: Lens B (stenfilcon A)

What is being measured

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

Subjective Handling Rating on Lens Removal
Subjective handling rating on lens removal was measured on a scale of 0-100 where 0=Unmanageable and 100=Excellent removal.
Measured: One week

Secondary outcomes (2)

Overall Lens Fit at Follow-up
Lens fit was reported as either optimum, acceptable, or unacceptable. To determine this, lens fit parameters (horizontal centration, vertical centration, corneal coverage, and lens movement) were measured on a 5-point scale (-2 to +2), where -2=Extremely nasal, 0=Optimum, and +2=Extremely temporal. Scores between -1 and +1 were considered "Acceptable". For overall lens fit to be 'acceptable', no parameters could be extreme. For a score to be 'optimum', all parameters needed to be optimum.
Measured: One Week
Biomicroscopy Score at Follow-up
Slit lamp biomicroscopy was used to assign grades to various biomicroscopic signs, as assessed by investigator, using Efron Grading Scales scored to the nearest 0.1 unit. Grading ranged from 0-4, where 0=None and 4=Severe.
Measured: One week

Timeline

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

1 Apr 20222 May 2023

First posted25 Aug 2021
Study start1 Apr 2022
Primary completion30 Sep 2022
Study completion2 May 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: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05020990
Sponsor's protocol ID: C20-691 (EX-MKTG-121)
Status last verified: Sep 2023
First submitted: 19 Aug 2021
Last updated: 20 Dec 2023
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 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses
ClinicalTrials.gov ID: NCT05020990
Acronym / sponsor ID: C20-691 (EX-MKTG-121)
Conditions: Astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 1 Apr 2022 (actual)
Primary completion: 30 Sep 2022 (actual)
Study completion: 2 May 2023 (actual)
First posted: 25 Aug 2021 (actual)
Results: Posted 20 Dec 2023

Clinical summary

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

This study aimed to compare the clinical performance of two daily disposable toric contact lenses.

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 (delefilcon A), Device: Lens B (stenfilcon A)Participants wore Lens A for one week, then crossed over to wear Lens B for one week.
Lens B, then Lens A	Experimental	Device: Lens A (delefilcon A), Device: Lens B (stenfilcon A)Participants wore Lens B for one week, then crossed over to wear Lens A for one week.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

They are at least 18 years old and have the capacity to volunteer.
They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
They are willing and able to follow the protocol.
They currently wear soft contact lenses or have done so in the past two years.
They have a spherical component of their contact lens prescription between Plano to - 6.00DS (inclusive).

Key exclusion criteria (11 listed)

They have an ocular disorder which would normally contra-indicate contact lens wear.
They have a systemic disorder, which would normally contra-indicate contact lens wear.
They are using any topical medication such as eye drops or ointment.
They are aphakic.
They have had corneal refractive surgery.

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 (delefilcon A)Daily disposable for one week	Device	Lens A, then Lens B, Lens B, then Lens A
Lens B (stenfilcon A)Daily disposable for one week	Device	Lens A, then Lens B, Lens B, then Lens A

Primary outcome

Subjective Handling Rating on Lens Removal
Time frame: One week
Subjective handling rating on lens removal was measured on a scale of 0-100 where 0=Unmanageable and 100=Excellent removal.

2 secondary outcomes

Overall Lens Fit at Follow-up
Time frame: One Week
Biomicroscopy Score at Follow-up
Time frame: One week

Results and safety

Results posted to the registry on 20 Dec 2023, 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 (Delefilcon A), Then Lens B (Stenfilcon A)	28	28
Lens B (Stenfilcon A), Then Lens A (Delefilcon A)	26	26

Primary outcome: Subjective Handling Rating on Lens Removal

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

Measure	Lens A n = 53	Lens B n = 52
Value	85.5 (17.7)	83.3 (20.1)

Population analysed: Lens A: all data for one participant was discounted, as the follow-up visit took place significantly outside the date range for this visit. Lens B: all data for a different participant was discounted, as the follow-up visit took place significantly outside the date range for this visit. Another participant's subjective scores and symptoms were not collected at the correct study visit in error, and their data was subsequently excluded from analysis.

2 secondary outcomes are reported in the full results.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Lens A	0 of 54 (0%)	5 of 54 (9.3%)	0 of 54
Lens B	0 of 54 (0%)	1 of 54 (1.9%)	0 of 54

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
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.

Philip Morgan principal investigator

Eurolens Research

3 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 (delefilcon A) and Lens B (stenfilcon A) in people with Astigmatism, run by CooperVision, Inc. at 3 sites 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 11 inclusion and 11 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 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 20 Dec 2023). 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?

Subjective Handling Rating on Lens Removal (time frame: One 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 NCT05020990.

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 20 Dec 2023.