MyopiaNCT01695369
Evaluation of Comfilcon A and Senofilcon A Lenses
A study testing Senofilcon A; Comfilcon A and Comfilcon A; Senofilcon A in people with Myopia, run by CooperVision, Inc. at 1 site in United States.
Trial summary
Evaluation of Comfilcon A and Senofilcon A Lenses Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- Senofilcon A; Comfilcon A and Comfilcon A; Senofilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Aug 2012
- 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
- Subjects must satisfy the following conditions prior to inclusion in the study:
- Has had an oculo-visual examination in the last two years
- Is at least 18 years of age and has full legal capacity to volunteer
- Has read and understood the information consent letter
- Is willing and able to follow instructions and maintain the appointment schedule
- Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction
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- Currently wears soft contact lenses at least 3 days a week, 8 hours a day
- Has clear corneas and no active ocular disease
- Has not worn lenses for at least 12 hours before the examination
- Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
- No amblyopia
- No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes)
- No clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection).
- No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology)
- No aphakia
- Has prescription to match the available power range.
Who cannot join
- Any of the following will render a subject ineligible for inclusion:
- Greater than 0.75 of refractive astigmatism in either eye
- Has never worn contact lenses before
- Wears contact lenses on an extended wear basis
- Has any systemic disease affecting ocular health
- Is a known sufferer of ocular allergies
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- Is taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
- Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities
- Is aphakic
- Has undergone corneal refractive surgery.
- Is wearing monovision
- Is participating in any other type of clinical or research study
- Female who is currently pregnant or is breast-feeding
- Has > grade 1 ocular corneal staining in both type and extent by > grade 2 in either type or extent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Houston College of Optometry, TERTC
Houston, Texas, 77204
About this study
Official title: Clinical Comfort Evaluation of Biofinity and Acuvue Oasys Lenses
Evaluation of Comfilcon A and Senofilcon A Lenses
Read the detailed description
Non-dispensing, single-masked, randomized, contralateral study comparing the test lens against the control lens. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye.
- Conditions
- Myopia
- Being tested
- Senofilcon A; Comfilcon A, Comfilcon A; Senofilcon A
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senofilcon A; Comfilcon ADevice
Senofilcon A; Comfilcon A
Comfilcon A; Senofilcon ADevice
Comfilcon A; Senofilcon A
| Study group | Role | What they receive |
|---|---|---|
| Senofilcon A | Active comparator | Senofilcon A; Comfilcon A Receives: Device: Senofilcon A; Comfilcon A; Device: Comfilcon A; Senofilcon A |
| Comfilcon A | Experimental | Comfilcon A; Senofilcon A Receives: Device: Senofilcon A; Comfilcon A; Device: Comfilcon A; Senofilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Responses for Comfort Rated on a 0-100 Visual Scale.
Subjective Patient Ratings measured using a Visual Analog Scale on a 0-100. (0=Cannot be worn. Causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever)
Measured: Baseline Insertion, 10 Minutes, 5 hours and 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2012
- Study completionAug 2012
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 MyopiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Bergmanson, OD, PhD, Principal investigator, University of Houston College of Optometry, TERTC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695369
- Sponsor's protocol ID
- CV-12-54
- Status last verified
- Jul 2020
- First submitted
- 26 Sep 2012
- Last updated
- 28 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comfort Evaluation of Biofinity and Acuvue Oasys Lenses
- ClinicalTrials.gov ID
- NCT01695369
- Acronym / sponsor ID
- CV-12-54
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 28 Sep 2012 (estimated)
- Results
- Posted 6 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of Comfilcon A and Senofilcon A Lenses
Detailed description
Non-dispensing, single-masked, randomized, contralateral study comparing the test lens against the control lens. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Senofilcon A | Active comparator | Device: Senofilcon A; Comfilcon A, Device: Comfilcon A; Senofilcon ASenofilcon A; Comfilcon A |
| Comfilcon A | Experimental | Device: Senofilcon A; Comfilcon A, Device: Comfilcon A; Senofilcon AComfilcon A; Senofilcon A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Has had an oculo-visual examination in the last two years
- Is at least 18 years of age and has full legal capacity to volunteer
- Has read and understood the information consent letter
- Is willing and able to follow instructions and maintain the appointment schedule
- Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction
Key exclusion criteria (14 listed)
- Greater than 0.75 of refractive astigmatism in either eye
- Has never worn contact lenses before
- Wears contact lenses on an extended wear basis
- Has any systemic disease affecting ocular health
- Is a known sufferer of ocular allergies
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 |
|---|---|---|
| Senofilcon A; Comfilcon ASenofilcon A; Comfilcon A | Device | Comfilcon A, Senofilcon A |
| Comfilcon A; Senofilcon AComfilcon A; Senofilcon A | Device | Comfilcon A, Senofilcon A |
Primary outcome
Subjective Responses for Comfort Rated on a 0-100 Visual Scale.
Time frame: Baseline Insertion, 10 Minutes, 5 hours and 10 hours
Subjective Patient Ratings measured using a Visual Analog Scale on a 0-100. (0=Cannot be worn. Causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- 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.
Jan Bergmanson, OD, PhD principal investigator
University of Houston College of Optometry, TERTC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Senofilcon A; Comfilcon A and Comfilcon A; Senofilcon A in people with Myopia, run by CooperVision, Inc. at 1 site in United States.
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 16 inclusion and 14 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 28 Jul 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 States. 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 6 Mar 2014). 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 Responses for Comfort Rated on a 0-100 Visual Scale. (time frame: Baseline Insertion, 10 Minutes, 5 hours and 10 hours). 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 28 Jul 2020.