AstigmatismNCT03006458
A Clinical Comparison of 2 Multifocal Toric XR (Extended Range) Contact Lenses
A study testing comfilcon A and omafilcon B in people with Astigmatism, run by CooperVision, Inc. at 1 site in United Kingdom.
Trial summary
This study aims to compare the clinical performance and subjective acceptance of the comfilcon A and the omafilcon B soft contact lenses. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Astigmatism
- What is being tested?
- comfilcon A and omafilcon B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2016to 6 Apr 2017
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will only be eligible for the study if:
- They are aged 40 - 70 years, inclusive.
- 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 have successfully completed the non-dispensing study (C16-597) as the lenses to be worn on this study (C16-599) are predetermined from their participation on study C16-597.
- They have a contact lens spherical prescription between +10.00 to -10.00D (Diopters) (inclusive).
Show all 15Show fewer
- They have astigmatism between of -0.75 and -5.75DC (based on the calculated ocular refraction) in each eye.
- They have an Add component to their spectacle refraction (between +0.75 and
- +2.50DS).
- They can be satisfactorily fitted with the study lenses.
- They can attain at least 0.30 logMAR binocular distance high contrast visual acuity with the study lenses within the available power range.
- They have successfully worn soft contact lenses in the last two years.
- They are willing to comply with the wear schedule (at least five days per week and for at least six hours per day).
- They agree not to participate in other clinical research for the duration of this study.
- They own a wearable pair of spectacles.
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 cataract surgery.
- They have had corneal refractive surgery.
Show all 12Show fewer
- They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- They are pregnant or breast-feeding.
- They have any clinically meaningful slit lamp findings contraindicating contact lens wear (e.g. ≥ Grade 3 finding of oedema, corneal neovascularisation, corneal staining, tarsal abnormalities, conjunctival injection, blepharitis/meibomian gland dysfunction) on the Efron classification scale or any other ocular abnormality that in the opinion of the investigator would contraindicate contact lens wear.
- They have any infectious disease (e.g. hepatitis) 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).
- They have 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
Official title: A Clinical Comparison of the Comfilcon A (Extended Range) XR Toric Multifocal and Omafilcon B Toric XR Multifocal Contact Lenses
This study aims to compare the clinical performance and subjective acceptance of the comfilcon A and the omafilcon B soft contact lenses.
Read the detailed description
This will be a randomized, subject-masked, crossover, bilateral study, controlled by cross comparison. Thirty subjects will use each lens type for two weeks in random sequence. Follow-up visits for each lens will be performed after two weeks of wear. Lenses will be worn on a daily wear basis.
The final optical design of comfilcon A contact lens was optimized to improve the quality and two further studies (CV-18-10 and CV-18-11) were conducted after completion of this study to evaluate the modified optical design.
- Conditions
- Astigmatism
- Being tested
- comfilcon A, omafilcon B
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comfilcon ADevice
toric contact lens
omafilcon BDevice
toric contact lens
| Study group | Role | What they receive |
|---|---|---|
| comfilcon A | Experimental | Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study.
The final optical design of comfilcon A contact lens was optimized to improve the quality and two further studies (CV-18-10 and CV-18-11) were conducted after completion of this study to evaluate the modified optical design. Receives: Device: comfilcon A |
| omafilcon B | Active comparator | Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. Receives: Device: omafilcon B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability
Investigator's acceptance on overall stability for comfilcon A and omafilcon B lenses assessed using grading scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for astigmatism, 4=Excellent orientation and optimum rotational.
Measured: Baseline
Stability
Investigator's acceptance on overall stability for comfilcon A and omafilcon B lenses assessed using grading scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for astigmatism, 4=Excellent orientation and optimum rotational.
Measured: 2 weeks
Overall Toric Lens Fit Acceptance
Overall toric lens fit acceptance is assessed for comfilcon A and omafilcon B lenses. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Measured: Baseline
Overall Toric Lens Fit Acceptance
Overall toric lens fit acceptance is assessed for comfilcon A and omafilcon B lenses. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Measured: 2 weeks
Comfort
Subjective ratings for comfort assessed. Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever
Measured: Baseline
Comfort
Subjective ratings for comfort assessed. Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever
Measured: 2 weeks
Overall Satisfaction
Subjective ratings for overall satisfaction for comfilcon A and omafilcon B lenses assessed. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied
Measured: 2 weeks
Dryness
Subjective ratings for dryness assessed. Scale 0-100, 0=cannot be worn, extremely dry; 100=no dryness experienced at any time
Measured: 2 weeks
Visual Fluctuation/ Stability
Subjective ratings for visual fluctuation/stability assessed. Scale 0-100, 0=totally unstable/ fluctuation/changing; 100=perfectly stable/not fluctuation/changing
Measured: 2 weeks
Handling
Subjective ratings for handling difficulty assessed at 2 weeks. Scale 0-100, 0=very difficult, 100=very easy
Measured: 2 weeks
Quality of Near Vision
Subjective ratings for quality of near vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.
Measured: 2 weeks
Quality of Intermediate Vision
Subjective ratings for quality of intermediate vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.
Measured: 2 weeks
Quality of Distance Vision
Subjective ratings for quality of distance vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.
Measured: 2 weeks
Quality of Vision While Driving During the Day
Subjective rating for quality of vision while driving during the day. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.
Measured: 2 weeks
Quality of Vision While Driving During the Night
Subjective ratings for quality of vision while driving at night. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.
Measured: 2 weeks
Ghosting at Near
Subjective ratings for ghosting at near assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable.
Measured: 2 weeks
Ghosting at Distance
Subjective ratings for ghosting at distance assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study startDec 2016
- Primary completion6 Apr 2017
- Study completion6 Apr 2017
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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006458
- Sponsor's protocol ID
- CV-16-28 (C16-599)
- Status last verified
- May 2020
- First submitted
- 27 Dec 2016
- Last updated
- 1 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Comparison of the Comfilcon A (Extended Range) XR Toric Multifocal and Omafilcon B Toric XR Multifocal Contact Lenses
- ClinicalTrials.gov ID
- NCT03006458
- Acronym / sponsor ID
- CV-16-28 (C16-599)
- Conditions
- Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- 6 Apr 2017 (actual)
- Study completion
- 6 Apr 2017 (actual)
- First posted
- 30 Dec 2016 (estimated)
- Results
- Posted 1 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the clinical performance and subjective acceptance of the comfilcon A and the omafilcon B soft contact lenses.
Detailed description
This will be a randomized, subject-masked, crossover, bilateral study, controlled by cross comparison. Thirty subjects will use each lens type for two weeks in random sequence. Follow-up visits for each lens will be performed after two weeks of wear. Lenses will be worn on a daily wear basis.
The final optical design of comfilcon A contact lens was optimized to improve the quality and two further studies (CV-18-10 and CV-18-11) were conducted after completion of this study to evaluate the modified optical design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| comfilcon A | Experimental | Device: comfilcon AParticipants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. The final optical design of comfilcon A contact lens was optimized to improve the quality and two further studies (CV-18-10 and CV-18-11) were conducted after completion of this study to evaluate the modified optical design. |
| omafilcon B | Active comparator | Device: omafilcon BParticipants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects will only be eligible for the study if:
- +2.50DS).
Key exclusion criteria (12 listed)
- Subjects will not be eligible to take part in the study if:
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 |
|---|---|---|
| comfilcon Atoric contact lens | Device | comfilcon A |
| omafilcon Btoric contact lens | Device | omafilcon B |
Primary outcome
Stability
Time frame: Baseline
Investigator's acceptance on overall stability for comfilcon A and omafilcon B lenses assessed using grading scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for astigmatism, 4=Excellent orientation and optimum rotational.
Stability
Time frame: 2 weeks
Investigator's acceptance on overall stability for comfilcon A and omafilcon B lenses assessed using grading scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for astigmatism, 4=Excellent orientation and optimum rotational.
Overall Toric Lens Fit Acceptance
Time frame: Baseline
Overall toric lens fit acceptance is assessed for comfilcon A and omafilcon B lenses. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Overall Toric Lens Fit Acceptance
Time frame: 2 weeks
Overall toric lens fit acceptance is assessed for comfilcon A and omafilcon B lenses. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Comfort
Time frame: Baseline
Subjective ratings for comfort assessed. Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever
Comfort
Time frame: 2 weeks
Subjective ratings for comfort assessed. Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever
Overall Satisfaction
Time frame: 2 weeks
Subjective ratings for overall satisfaction for comfilcon A and omafilcon B lenses assessed. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied
Dryness
Time frame: 2 weeks
Subjective ratings for dryness assessed. Scale 0-100, 0=cannot be worn, extremely dry; 100=no dryness experienced at any time
Visual Fluctuation/ Stability
Time frame: 2 weeks
Subjective ratings for visual fluctuation/stability assessed. Scale 0-100, 0=totally unstable/ fluctuation/changing; 100=perfectly stable/not fluctuation/changing
Handling
Time frame: 2 weeks
Subjective ratings for handling difficulty assessed at 2 weeks. Scale 0-100, 0=very difficult, 100=very easy
Quality of Near Vision
Time frame: 2 weeks
Subjective ratings for quality of near vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.
Quality of Intermediate Vision
Time frame: 2 weeks
Subjective ratings for quality of intermediate vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.
Quality of Distance Vision
Time frame: 2 weeks
Subjective ratings for quality of distance vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.
Quality of Vision While Driving During the Day
Time frame: 2 weeks
Subjective rating for quality of vision while driving during the day. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.
Quality of Vision While Driving During the Night
Time frame: 2 weeks
Subjective ratings for quality of vision while driving at night. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.
Ghosting at Near
Time frame: 2 weeks
Subjective ratings for ghosting at near assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable.
Ghosting at Distance
Time frame: 2 weeks
Subjective ratings for ghosting at distance assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comfilcon A and omafilcon B 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 15 inclusion and 12 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 1 Jun 2020. 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 1 Jun 2020). 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?
Stability (time frame: Baseline). The study lists 17 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 1 Jun 2020.