AstigmatismNCT04536571
Vision Stability and Preference for Soft Toric vs. Soft Spherical Contact Lenses
A study testing Test Contact lens in people with Astigmatism and Myopia, run by CooperVision, Inc. at 1 site in United Kingdom.
Trial summary
The principal hypothesis is to be tested in this work is that vision stability (the primary outcome measure) with a spherical contact lens correction vs. a toric contact lens correction will be the same. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Astigmatism, Myopia
- What is being tested?
- Test Contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Sep 2020to 7 Jun 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- They are aged 18-35 years and have 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 are an existing wearer of soft spherical contact lenses in both eyes.
- They have a spherical component of their spectacle refractive error between
- -0.50DS and -6.50DS in both eyes.
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- They have a cylindrical component of their spectacle refractive error between
- -0.75DC and -1.25DC in both eyes.
- They can be fitted satisfactorily with both lens types.
- They own an acceptable pair of spectacles.
- They agree not to participate in other clinical research for the duration of the 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 (including comfort drops) or ointment on a regular basis.
- 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 any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
- 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
1 site in 1 country.
About this study
The principal hypothesis is to be tested in this work is that vision stability (the primary outcome measure) with a spherical contact lens correction vs. a toric contact lens correction will be the same.
Read the detailed description
This will be a randomised, subject-masked, crossover, bilateral non-dispensing study, controlled by cross-comparison. Thirty subjects will use each lens type at a single visit in random sequence.
- Conditions
- Astigmatism, Myopia
- Being tested
- Test Contact lens, Control Contact lens
- Medical subject headings
- Astigmatism, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Contact lensDevice
Also called Soft comfilcon A toric contact lenses
Subjects will be randomized to wear test lenses for 30 minutes, and then cross-over to control lenses.
Control Contact lensDevice
Also called Soft comfilcon A sphere contact lenses
Subjects will be randomized to wear control lenses for 30 minutes, and then cross-over to test lenses.
| Study group | Role | What they receive |
|---|---|---|
| Test Contact lens | Experimental | Subjects will be randomized to wear test lenses for 30 minutes, and then cross-over to control lenses. Receives: Device: Test Contact lens; Device: Control Contact lens |
| Control Contact lens | Active comparator | Subjects will be randomized to wear control lenses for 30 minutes, and then cross-over to test lenses. Receives: Device: Test Contact lens; Device: Control Contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vision Stability While Doing Tasks on Mobile Phone
Vision stability was assessed by study subjects while doing tasks on mobile phone using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss)
Measured: 30 minutes
Vision Stability While Doing Tasks on Desktop
Vision stability was assessed by study subjects while doing tasks on desktop using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss)
Measured: 30 minutes
Vision Stability While Walking
Vision stability was assessed by study subjects while walking using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss)
Measured: 30 minutes
Secondary outcomes (2)
Lens Fit for Test Contact Lens
Lens fit was assessed for lens rotation after 10 minutes for toric fit. Lens mislocation from optimal position was measured in 0°, 1-5°, 6-10°, 11-15°, 16-20°, More than 20°.
Measured: 10 minutes
Lens Fit
Lens fit was assessed as either 'acceptable' or 'not acceptable' for standard fit by study investigator.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start3 Sep 2020
- Primary completion7 Jun 2021
- Study completion7 Jun 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Morgan, PhD., Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536571
- Sponsor's protocol ID
- C19-679 (EX-MKTG-115)
- Status last verified
- Nov 2021
- First submitted
- 14 Aug 2020
- Last updated
- 22 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vision Stability and Preference for Soft Toric vs. Soft Spherical Contact Lenses
- ClinicalTrials.gov ID
- NCT04536571
- Acronym / sponsor ID
- C19-679 (EX-MKTG-115)
- Conditions
- Astigmatism, Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 7 Jun 2021 (actual)
- Study completion
- 7 Jun 2021 (actual)
- First posted
- 2 Sep 2020 (actual)
- Results
- Posted 22 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The principal hypothesis is to be tested in this work is that vision stability (the primary outcome measure) with a spherical contact lens correction vs. a toric contact lens correction will be the same.
Detailed description
This will be a randomised, subject-masked, crossover, bilateral non-dispensing study, controlled by cross-comparison. Thirty subjects will use each lens type at a single visit in random sequence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Contact lens | Experimental | Device: Test Contact lens, Device: Control Contact lensSubjects will be randomized to wear test lenses for 30 minutes, and then cross-over to control lenses. |
| Control Contact lens | Active comparator | Device: Test Contact lens, Device: Control Contact lensSubjects will be randomized to wear control lenses for 30 minutes, and then cross-over to test lenses. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- They are aged 18-35 years and have 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 are an existing wearer of soft spherical contact lenses in both eyes.
- They have a spherical component of their spectacle refractive error between
Key exclusion criteria (10 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 (including comfort drops) or ointment on a regular basis.
- 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 |
|---|---|---|
| Test Contact lensAlso: Soft comfilcon A toric contact lensesSubjects will be randomized to wear test lenses for 30 minutes, and then cross-over to control lenses. | Device | Control Contact lens, Test Contact lens |
| Control Contact lensAlso: Soft comfilcon A sphere contact lensesSubjects will be randomized to wear control lenses for 30 minutes, and then cross-over to test lenses. | Device | Control Contact lens, Test Contact lens |
Primary outcome
Vision Stability While Doing Tasks on Mobile Phone
Time frame: 30 minutes
Vision stability was assessed by study subjects while doing tasks on mobile phone using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss)
Vision Stability While Doing Tasks on Desktop
Time frame: 30 minutes
Vision stability was assessed by study subjects while doing tasks on desktop using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss)
Vision Stability While Walking
Time frame: 30 minutes
Vision stability was assessed by study subjects while walking using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss)
2 secondary outcomes
Lens Fit for Test Contact Lens
Time frame: 10 minutes
Lens Fit
Time frame: 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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, PhD. principal investigator
University of Manchester
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 Contact lens in people with Astigmatism and Myopia, 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 11 inclusion and 10 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 22 Nov 2021. 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 22 Nov 2021). 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?
Vision Stability While Doing Tasks on Mobile Phone (time frame: 30 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2021.