AstigmatismNCT05633082
A Clinical Performance of Two Soft Toric Contact Lenses
A study testing Lens 1 (omafilcon B) and Lens 2 (fanfilcon A) in people with Astigmatism, run by CooperVision, Inc. at 1 site in United Kingdom.
Trial summary
The study objective was to gather short-term clinical performance data for two soft 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 1 (omafilcon B) and Lens 2 (fanfilcon A)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Sep 2022to 30 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- They are of legal age (18) and 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 within the past two years.
- They have ocular astigmatism in both eyes of between 0.75DC and 3.00DC.
- They are expected to be able to be fitted with the study lenses within the power range available.
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 lactating.
- They have an eye or health condition including an immunosuppressive or infectious disease 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 have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.
Trial locations and contacts
1 site in 1 country.
About this study
The study objective was to gather short-term clinical performance data for two soft toric contact lenses.
Read the detailed description
This participant-masked, non-randomized, controlled non-dispensing study was to compare the performance of two soft toric lenses. Participants attended one study visit which lasted for approximately 1.5 hours.
- Conditions
- Astigmatism
- Being tested
- Lens 1 (omafilcon B), Lens 2 (fanfilcon 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 1 (omafilcon B)Device
Toric daily wear contact lens for 15 minutes
Lens 2 (fanfilcon A)Device
Toric daily wear contact lens for 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Lens 1 | Experimental | All participants wore Lens 1 for 15 minutes (Period 1) Receives: Device: Lens 1 (omafilcon B) |
| Lens 2 | Experimental | All participants wore Lens 2 for 15 minutes (Period 2) Receives: Device: Lens 2 (fanfilcon A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Overall Score
The subjective overall impression of the contact lens (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Extremely poor, 100=Excellent.
Measured: 15 minutes
Secondary outcomes (2)
Subjective Comfort
Subjective comfort (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Causes pain,100=Excellent.
Measured: 15 minutes
Subjective Vision
Subjective vision (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Unacceptable,100=Excellent.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start21 Sep 2022
- Primary completion30 Sep 2022
- Study completion30 Sep 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.
- 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- All participants received Lens 1 and then Lens 2 in fixed-sequence order.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Morgan, PhD, MCOptom, Principal investigator, Eurolens Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633082
- Sponsor's protocol ID
- EX-MKTG-143
- Status last verified
- Nov 2022
- First submitted
- 21 Nov 2022
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Performance of Two Soft Toric Contact Lenses
- ClinicalTrials.gov ID
- NCT05633082
- Acronym / sponsor ID
- EX-MKTG-143
- Conditions
- Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 1 Dec 2022 (actual)
- Results
- Posted 7 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objective was to gather short-term clinical performance data for two soft toric contact lenses.
Detailed description
This participant-masked, non-randomized, controlled non-dispensing study was to compare the performance of two soft toric lenses. Participants attended one study visit which lasted for approximately 1.5 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All participants received Lens 1 and then Lens 2 in fixed-sequence order.
| Arm | Type | Receives |
|---|---|---|
| Lens 1 | Experimental | Device: Lens 1 (omafilcon B)All participants wore Lens 1 for 15 minutes (Period 1) |
| Lens 2 | Experimental | Device: Lens 2 (fanfilcon A)All participants wore Lens 2 for 15 minutes (Period 2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- They are of legal age (18) and 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 within the past two years.
- They have ocular astigmatism in both eyes of between 0.75DC and 3.00DC.
Key exclusion criteria (9 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 1 (omafilcon B)Toric daily wear contact lens for 15 minutes | Device | Lens 1 |
| Lens 2 (fanfilcon A)Toric daily wear contact lens for 15 minutes | Device | Lens 2 |
Primary outcome
Subjective Overall Score
Time frame: 15 minutes
The subjective overall impression of the contact lens (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Extremely poor, 100=Excellent.
2 secondary outcomes
Subjective Comfort
Time frame: 15 minutes
Subjective Vision
Time frame: 15 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, MCOptom 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 Lens 1 (omafilcon B) and Lens 2 (fanfilcon A) 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 6 inclusion and 9 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 7 Nov 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 7 Nov 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 Overall Score (time frame: 15 minutes). 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 7 Nov 2023.