AstigmatismNCT04613882
Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses
A study testing Soft Toric Custom Made Contact lens, Soft Spherical Contact Lenses and Spectacle Correction in people with Astigmatism, run by CooperVision, Inc. at 1 site in United Kingdom.
Trial summary
The aim of this work is to undertake a range of vision-related measures with soft toric contact lenses soft spherical contact lenses and spectacle lens correction across a range of levels of astigmatism. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Astigmatism
- What is being tested?
- Soft Toric Custom Made Contact lens, Soft Spherical Contact Lenses and Spectacle Correction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Sep 2021to 21 Jun 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -
- Subjects will only be eligible for the study if:
- They are of legal age between 18 and 40 years.
- 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 current wearers of any soft contact lens (i.e. have worn lenses in the last six months).
Show all 12Show fewer
- They have refractive ocular astigmatism between 0.00DC and -1.50DC in one or both eyes.
- They have a spherical component to their ocular refractive error between 0.00 and - 6.00 DS.
- They could attain at least 0.10 logMAR distance high contrast visual acuity in one eye with the study lenses within the available power range.
- 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 this study.
Who cannot join
- -
- Subjects will not be eligible to take part in the study if:
- 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 have had corneal refractive surgery.
Show all 13Show fewer
- They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- 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 an amblyopic eye, in which case only dominant eye will be assessed for that subject.
- They have an infectious disease (e.g. hepatitis), any immunosuppressive disease (e.g. HIV) or diabetes.
- They have a history of severe allergic reaction or anaphylaxis.
- They have taken part in any other contact lens clinical trial or research, within two weeks prior to starting this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses Over a Range of Refractive Astigmatism
The aim of this work is to undertake a range of vision-related measures with soft toric contact lenses soft spherical contact lenses and spectacle lens correction across a range of levels of astigmatism.
Read the detailed description
This will be a randomised, crossover, partially subject-masked (for contact lenses only), non-dispensing study, controlled by cross-comparison.
- Conditions
- Astigmatism
- Being tested
- Soft Toric Custom Made Contact lens, Soft Spherical Contact Lenses, Spectacle Correction
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft Toric Custom Made Contact lensDevice
Subjects will be randomized to wear soft toric custom made lenses for 30 minutes in one eye with other eye patched.
Soft Spherical Contact LensesDevice
Subjects will be randomized to wear soft spherical contact lenses for 30 minutes in one eye with other eye patched.
Spectacle CorrectionDevice
Subjects will be randomized to wear spectacle Correction for 30 minutes in one eye with other eye patched.
| Study group | Role | What they receive |
|---|---|---|
| Soft Toric Custom Made contact lenses | Experimental | Subjects will be randomized to wear Soft Toric custom made contact lenses for 30 minutes in one eye with other eye patched. Receives: Device: Soft Toric Custom Made Contact lens; Device: Soft Spherical Contact Lenses; Device: Spectacle Correction |
| Soft Spherical Contact Lenses | Active comparator | Subjects will be randomized to wear soft spherical contact lens for 30 minutes in one eye with other eye patched Receives: Device: Soft Toric Custom Made Contact lens; Device: Soft Spherical Contact Lenses; Device: Spectacle Correction |
| Spectacle Correction | Active comparator | Subjects will be randomized to wear spectacle Correction for 30 minutes in one eye with other eye patched. Receives: Device: Soft Toric Custom Made Contact lens; Device: Soft Spherical Contact Lenses; Device: Spectacle Correction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Visual acuity was assessed using logMAR for each intervention.
Measured: Baseline with low contrast VA
Visual Acuity
Visual acuity was assessed using logMAR for each intervention.
Measured: After 30 minutes of dispense (Low Contrast VA)
Visual Acuity
Visual acuity was assessed using logMAR for each intervention.
Measured: Baseline with High contrast VA
Visual Acuity
Visual acuity was assessed using logMAR for each intervention.
Measured: After 30 minutes of dispense (High Contrast VA)
Secondary outcomes (12)
Slit Lamp Biomicroscopy Findings - Conjunctival Redness
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments done were recorded prior to the first intervention.
Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Measured: Entrance (Prior to wear of study lens)
Slit Lamp Biomicroscopy Findings - Conjunctival Redness
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Measured: At Exit (After 30 minutes in each of three interventions)
Slit Lamp Biomicroscopy Findings - Limbal Redness
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Measured: Entrance (Prior to wear of study lens)
Slit Lamp Biomicroscopy Findings - Limbal Redness
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Measured: At Exit (After 30 minutes in each of three interventions)
Slit Lamp Biomicroscopy Findings - Corneal Staining
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Measured: Entrance (Prior to wear of study lens)
Slit Lamp Biomicroscopy Findings - Corneal Staining
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Measured: At Exit (After 30 minutes in each of three interventions)
Slit Lamp Biomicroscopy Findings - Conjunctival Staining
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments done were recorded prior to the first intervention.
Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Measured: Entrance (Prior to wear of study lens)
Slit Lamp Biomicroscopy Findings - Conjunctival Staining
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Measured: At Exit (After 30 minutes in each of three interventions)
Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments done were recorded prior to the first intervention.
Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Measured: Entrance (Prior to wear of study lens)
Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments were done following the removal of the third intervention.
Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Measured: At Exit (After 30 minutes in each of three interventions)
Slit Lamp Biomicroscopy Findings - Corneal Oedema
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Measured: Entrance (Prior to wear of study lens)
Slit Lamp Biomicroscopy Findings - Corneal Oedema
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments were done following the removal of the third intervention.
Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Measured: At Exit (After 30 minutes in each of three interventions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start28 Sep 2021
- Primary completion21 Jun 2022
- Study completion21 Jun 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Read, Principal investigator, Eurolens Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613882
- Sponsor's protocol ID
- C19-683 (EX-MKTG-116)
- Status last verified
- May 2022
- First submitted
- 28 Oct 2020
- Last updated
- 11 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Read M, Morgan P, Maldonado-Codina C, Orsborn G, Vega J, Navascues-Cornago M. Evaluating the visual benefits of toric soft contact lenses using a novel pupil-controlled vision testing system. Cont Lens Anterior Eye. 2025 Apr;49(2):102604. doi: 10.1016/j.clae.2025.102604. Epub 2026 Jan 23.
PubMed 41579512
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses Over a Range of Refractive Astigmatism
- ClinicalTrials.gov ID
- NCT04613882
- Acronym / sponsor ID
- C19-683 (EX-MKTG-116)
- Conditions
- Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 3 Nov 2020 (actual)
- Results
- Posted 11 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this work is to undertake a range of vision-related measures with soft toric contact lenses soft spherical contact lenses and spectacle lens correction across a range of levels of astigmatism.
Detailed description
This will be a randomised, crossover, partially subject-masked (for contact lenses only), non-dispensing study, controlled by cross-comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Soft Toric Custom Made contact lenses | Experimental | Device: Soft Toric Custom Made Contact lens, Device: Soft Spherical Contact Lenses, Device: Spectacle CorrectionSubjects will be randomized to wear Soft Toric custom made contact lenses for 30 minutes in one eye with other eye patched. |
| Soft Spherical Contact Lenses | Active comparator | Device: Soft Toric Custom Made Contact lens, Device: Soft Spherical Contact Lenses, Device: Spectacle CorrectionSubjects will be randomized to wear soft spherical contact lens for 30 minutes in one eye with other eye patched |
| Spectacle Correction | Active comparator | Device: Soft Toric Custom Made Contact lens, Device: Soft Spherical Contact Lenses, Device: Spectacle CorrectionSubjects will be randomized to wear spectacle Correction for 30 minutes in one eye with other eye patched. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- -
- They are of legal age between 18 and 40 years.
- 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 current wearers of any soft contact lens (i.e. have worn lenses in the last six months).
Key exclusion criteria (13 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 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 |
|---|---|---|
| Soft Toric Custom Made Contact lensSubjects will be randomized to wear soft toric custom made lenses for 30 minutes in one eye with other eye patched. | Device | Soft Spherical Contact Lenses, Soft Toric Custom Made contact lenses, Spectacle Correction |
| Soft Spherical Contact LensesSubjects will be randomized to wear soft spherical contact lenses for 30 minutes in one eye with other eye patched. | Device | Soft Spherical Contact Lenses, Soft Toric Custom Made contact lenses, Spectacle Correction |
| Spectacle CorrectionSubjects will be randomized to wear spectacle Correction for 30 minutes in one eye with other eye patched. | Device | Soft Spherical Contact Lenses, Soft Toric Custom Made contact lenses, Spectacle Correction |
Primary outcome
Visual Acuity
Time frame: Baseline with low contrast VA
Visual acuity was assessed using logMAR for each intervention.
Visual Acuity
Time frame: After 30 minutes of dispense (Low Contrast VA)
Visual acuity was assessed using logMAR for each intervention.
Visual Acuity
Time frame: Baseline with High contrast VA
Visual acuity was assessed using logMAR for each intervention.
Visual Acuity
Time frame: After 30 minutes of dispense (High Contrast VA)
Visual acuity was assessed using logMAR for each intervention.
12 secondary outcomes
Slit Lamp Biomicroscopy Findings - Conjunctival Redness
Time frame: Entrance (Prior to wear of study lens)
Slit Lamp Biomicroscopy Findings - Conjunctival Redness
Time frame: At Exit (After 30 minutes in each of three interventions)
Slit Lamp Biomicroscopy Findings - Limbal Redness
Time frame: Entrance (Prior to wear of study lens)
Slit Lamp Biomicroscopy Findings - Limbal Redness
Time frame: At Exit (After 30 minutes in each of three interventions)
Slit Lamp Biomicroscopy Findings - Corneal Staining
Time frame: Entrance (Prior to wear of study lens)
Slit Lamp Biomicroscopy Findings - Corneal Staining
Time frame: At Exit (After 30 minutes in each of three interventions)
Slit Lamp Biomicroscopy Findings - Conjunctival Staining
Time frame: Entrance (Prior to wear of study lens)
Slit Lamp Biomicroscopy Findings - Conjunctival Staining
Time frame: At Exit (After 30 minutes in each of three interventions)
Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis
Time frame: Entrance (Prior to wear of study lens)
Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis
Time frame: At Exit (After 30 minutes in each of three interventions)
Slit Lamp Biomicroscopy Findings - Corneal Oedema
Time frame: Entrance (Prior to wear of study lens)
Slit Lamp Biomicroscopy Findings - Corneal Oedema
Time frame: At Exit (After 30 minutes in each of three interventions)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41579512Read M, Morgan P, Maldonado-Codina C, Orsborn G, Vega J, Navascues-Cornago M. Evaluating the visual benefits of toric soft contact lenses using a novel pupil-controlled vision testing system. Cont Lens Anterior Eye. 2025 Apr;49(2):102604. doi: 10.1016/j.clae.2025.102604. Epub 2026 Jan 23.
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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.
Michael Read principal investigator
Eurolens Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft Toric Custom Made Contact lens, Soft Spherical Contact Lenses and Spectacle Correction in people with Astigmatism, 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 12 inclusion and 13 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 Oct 2023. 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 11 Oct 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?
Visual Acuity (time frame: Baseline with low contrast VA). The study lists 4 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 NCT04613882, which also lists 1 linked publication.
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 Oct 2023.