Astigmatism BilateralNCT03684928
A Bilateral Dispensing Comparison of Comfilcon A Over Senofilcon C Contact Lenses
A study testing Comfilcon A (test) in people with Astigmatism Bilateral, run by CooperVision, Inc. at 1 site in Canada.
Trial summary
The aim of this study is to evaluate the subjective acceptance of Comfilcon A contact lenses when worn on a daily wear modality over one month. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Astigmatism Bilateral
- What is being tested?
- Comfilcon A (test)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 23 Jul 2018to 1 Feb 2019
- 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- A person is eligible for inclusion in the study if he/she:
- Is at least 17 years of age and has full legal capacity to volunteer;
- Has had a self-reported oculo-visual examination in the last two years.
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Is an adapted soft contact lens wearer, who currently wears contact lenses for a minimum 3 days/week and 8 hours/day AND who anticipates no difficulty wearing CLs for 6 days/week, 10 hours /day.
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- Is willing to wear contact lens in both eyes for the duration of the study;
- Has a minimum astigmatism of - 0.75, determined by refraction;
- Can be fit with the two study contact lens types in the powers available;
- Has a distance visual acuity of 0.20 logMAR (approx 20/30) or better, determined by refraction;
- Can achieve a distance visual acuity of 0.20 logMAR (approx 20/30) or better in each eye with the study contact lenses.
- Has clear corneas and no active* ocular disease;
Who cannot join
- A person will be excluded from the study if he/she:
- Is participating in any concurrent clinical trial;
- Has any known active* ocular disease and/or infection;
- Has a systemic condition that in the opinion of the investigator may affect a study measure;
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;
- Has known sensitivity to fluorescein dye or products to be used in the study;
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- Appears to have any active* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;
- Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
- Is aphakic;
- Has undergone refractive error surgery;
- Has participated in the previous QUENA study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Bilateral Dispensing Comparison of Biofinity Toric and Acuvue Vita for Astigmatism
The aim of this study is to evaluate the subjective acceptance of Comfilcon A contact lenses when worn on a daily wear modality over one month.
Read the detailed description
This study is a 30-subjects prospective, double-masked (investigator and participant), bilateral, randomized, one month cross-over dispensing study comparing subject acceptance of Comfilcon A against Senofilcon A contact lenses.
- Conditions
- Astigmatism Bilateral
- Being tested
- Comfilcon A (test), Senofilcon C (control)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comfilcon A (test)Device
Daily wear contact lenses
Senofilcon C (control)Device
Daily wear contact lenses
| Study group | Role | What they receive |
|---|---|---|
| Comfilcon A (test) | Active comparator | Participants were randomized to wear either test or control contact lenses bilaterally for one month during the cross-over study. Receives: Device: Comfilcon A (test); Device: Senofilcon C (control) |
| Senofilcon C (control) | Active comparator | Participants were randomized to wear either test or control contact lenses bilaterally for one month during the cross-over study. Receives: Device: Comfilcon A (test); Device: Senofilcon C (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of Insertion(Handling)
Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)
Measured: Baseline
Ease of Insertion (Handling)
Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)
Measured: 2 weeks
Ease of Insertion(Handling)
Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)
Measured: 1 month
Secondary outcomes (2)
Rotational Recovery After Lens Mislocation
Lens relocation after 10 blinks, after 30º rotation mislocation
Measured: Baseline
Rotational Recovery After Lens Mislocation
Lens relocation after 10 blinks, after 30º rotation mislocation.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start23 Jul 2018
- Primary completion14 Dec 2018
- Study completion1 Feb 2019
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 Astigmatism BilateralStudies 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
- Model description
- Prospective, double-masked, bilateral, randomized, one month cross-over dispensing study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lyndon Jones, PhD FCOptom, Principal investigator, Director, Centre for Ocular Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684928
- Sponsor's protocol ID
- EX-MKTG-94
- Status last verified
- Apr 2019
- First submitted
- 19 Sep 2018
- Last updated
- 26 Jun 2020
- 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 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bilateral Dispensing Comparison of Biofinity Toric and Acuvue Vita for Astigmatism
- ClinicalTrials.gov ID
- NCT03684928
- Acronym / sponsor ID
- EX-MKTG-94
- Conditions
- Astigmatism Bilateral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 26 Sep 2018 (actual)
- Results
- Posted 26 Jun 2020
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 study is to evaluate the subjective acceptance of Comfilcon A contact lenses when worn on a daily wear modality over one month.
Detailed description
This study is a 30-subjects prospective, double-masked (investigator and participant), bilateral, randomized, one month cross-over dispensing study comparing subject acceptance of Comfilcon A against Senofilcon A contact lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Prospective, double-masked, bilateral, randomized, one month cross-over dispensing study.
| Arm | Type | Receives |
|---|---|---|
| Comfilcon A (test) | Active comparator | Device: Comfilcon A (test), Device: Senofilcon C (control)Participants were randomized to wear either test or control contact lenses bilaterally for one month during the cross-over study. |
| Senofilcon C (control) | Active comparator | Device: Comfilcon A (test), Device: Senofilcon C (control)Participants were randomized to wear either test or control contact lenses bilaterally for one month during the cross-over study. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Is at least 17 years of age and has full legal capacity to volunteer;
- Has had a self-reported oculo-visual examination in the last two years.
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Is an adapted soft contact lens wearer, who currently wears contact lenses for a minimum 3 days/week and 8 hours/day AND who anticipates no difficulty wearing CLs for 6 days/week, 10 hours /day.
Key exclusion criteria (11 listed)
- Is participating in any concurrent clinical trial;
- Has any known active* ocular disease and/or infection;
- Has a systemic condition that in the opinion of the investigator may affect a study measure;
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;
- Has known sensitivity to fluorescein dye or products to be used in the study;
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 A (test)Daily wear contact lenses | Device | Comfilcon A (test), Senofilcon C (control) |
| Senofilcon C (control)Daily wear contact lenses | Device | Comfilcon A (test), Senofilcon C (control) |
Primary outcome
Ease of Insertion(Handling)
Time frame: Baseline
Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)
Ease of Insertion (Handling)
Time frame: 2 weeks
Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)
Ease of Insertion(Handling)
Time frame: 1 month
Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)
2 secondary outcomes
Rotational Recovery After Lens Mislocation
Time frame: Baseline
Rotational Recovery After Lens Mislocation
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Astigmatism Bilateral
Active, not recruiting
Spectacle Prescribing in Early Childhood
Astigmatism Bilateral, Eyeglasses
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.
Lyndon Jones, PhD FCOptom principal investigator
Director, Centre for Ocular Research and Education
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 (test) in people with Astigmatism Bilateral, run by CooperVision, Inc. at 1 site in Canada.
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 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 26 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 Canada. 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 26 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?
Ease of Insertion(Handling) (time frame: Baseline). 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 26 Jun 2020.