MyopiaNCT02024698
Multi-center Clinical Evaluation of PC 1-Day vs 1-Day Acuvue Moist
A study testing omafilcon A and etafilcon A in people with Myopia, run by CooperVision, Inc. at 4 sites in United States.
Trial summary
The objective of this study is to compare the clinical performance of ProClear 1-Day versus 1-Day Acuvue Moist each for one week of daily disposable wear. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Myopia
- What is being tested?
- omafilcon A and etafilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2014to Mar 2014
- 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
- No healthy volunteers
- Adult
Who may be able to join
- A person is eligible for inclusion in the study if he/she:
- Is between 18 and 40 years of age (inclusive)
- Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study.
- Has had a self-reported visual exam in the last two years
- Is an adapted soft CL (Contact Lens) wearer
- Must be able to wear their lenses at least 6 full days over the 7 days; 14 hours per day, assuming there are no contraindications for doing so
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- Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
- Has less than 0.75D (Diopters) spectacle cylinder in each eye.
- Is correctable to a visual acuity of 20/25 or better in both eyes
- Has clear corneas and no active ocular disease
- Has read, understood and signed the information consent letter.
- Is willing to comply with the wear schedule (at least 40 hrs per week)
- Is willing to comply with the visit schedule
Who cannot join
- A person will be excluded from the study if he/she:
- Has never worn contact lenses before.
- Currently wears rigid gas permeable contact lenses.
- Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
- Has a CL prescription outside the range of - 1.00 to -6.00D
- Has a spectacle cylinder greater than -0.50D of cylinder in either eye.
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- Has best corrected spectacle distance vision worse then 20/25 in either eye.
- Has any systemic disease affecting ocular health.
- Is using any systemic or topical medications that will affect ocular health.
- Has any ocular pathology or severe insufficiency of lacrimal secretion
- Has persistent, clinically significant corneal or conjunctival staining
- Has active neovascularization or any central corneal scars.
- Is aphakic.
- Is presbyopic.
- Has undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Drs. Quinn, Foster & Assoc.
Athens, Ohio, 45701
Lake Zurich Eye Care
Lake Zurich, Illinois, 60047
Vision Professionals
New Albany, Ohio, 43054
Phoenix Eye Care, PLLC
Phoenix, Arizona, 85032
About this study
The objective of this study is to compare the clinical performance of ProClear 1-Day versus 1-Day Acuvue Moist each for one week of daily disposable wear.
Read the detailed description
The purpose of this cross-over study is to evaluate the clinical performance of the ProClear-1 Day in comparison with 1-Day Acuvue® Moist®. In particular, the study will focus on lens wearing comfort.
- Conditions
- Myopia
- Being tested
- omafilcon A, etafilcon A
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omafilcon ADevice
Also called Proclear 1 Day (omafilcon A)
contact lens
etafilcon ADevice
Also called 1-Day Acuvue Moist (etafilcon A)
contact lens
| Study group | Role | What they receive |
|---|---|---|
| omafilcon A | Active comparator | Study participants are randomized to wear omafilcon A lenses. Receives: Device: omafilcon A |
| etafilcon A | Active comparator | Study participants are randomized to wear etafilcon A lenses. Receives: Device: etafilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort (Subjective Assessment)
Subjective Assessment of comfort on insertion at baseline for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel)
Measured: Baseline
Comfort (Subjective Assessment)
Subjective Assessment: Insertion Comfort, Comfort During Day, Comfort Prior to Removal, Comfort Overall for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel)
Measured: 1 Week
Hydration (Subjective Assessment)
Subjective Assessment of hydration on insertion at baseline for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic)
Measured: Baseline
Hydration (Subjective Assessment)
Subjective Assessment: Initial Hydration, Hydration During Day, Hydration Prior to Removal for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic)
Measured: 1 Week
Vision Quality (Subjective Assessment)
Subjective Assessment: Visual quality on insertion at baseline for each pair using questionnaire and rated on subjective response scale (0-10; 0= clear vision, 10=perfectly sharp)
Measured: Baseline
Vision Satisfaction (Subjective Assessment)
Subjective Assessment: Vision Satisfaction for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very unsatisfied, 10=very satisfied)
Measured: 1 Week
Dryness (Subjective Assessment)
Subjective Assessment: Dryness During Day, Dryness Prior to Removal, Overall Dryness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dry, 10=no dryness)
Measured: 1 Week
Handling (Subjective Assessment)
Subjective Assessment: Handling on Insertion and Removal, Overall Handling for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very difficult, 10=very easy)
Measured: 1 Week
Eye Whiteness/Redness (Subjective Assessment)
Subjective Assessment: Eye Whiteness/Redness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= significant redness, 10=totally white)
Measured: 1 Week
Overall Sensation of Smoothness (Subjective Assessment)
Subjective Assessment: Overall sensation of smoothness at 1 week wear for each pair when asked "How would you rate the overall sensation of smoothness (deposit resistance) of the first study lenses, over the last week of wear?" (Likert 1-5; 1=excellent, 2=good, 3=average, 4=below average, 5=poor)
Measured: 1 Week
Overall Satisfaction for Lens
Subjective Assessment: Satisfaction overall at 1 Week wear for each pair when asked "Overall, how satisfied was the subject with the study lenses, during the last week, with regards to: Overall?" (Likert 1-4; 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied)
Measured: 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2014
- Study completionMar 2014
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donald Siegel, OD, Principal investigator, Sun City West Eye Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024698
- Sponsor's protocol ID
- EX-MKTG-43
- Status last verified
- Jul 2020
- First submitted
- 27 Dec 2013
- Last updated
- 30 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 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Clinical Evaluation of PC 1-Day vs 1-Day Acuvue Moist
- ClinicalTrials.gov ID
- NCT02024698
- Acronym / sponsor ID
- EX-MKTG-43
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Jan 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 31 Dec 2013 (estimated)
- Results
- Posted 20 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare the clinical performance of ProClear 1-Day versus 1-Day Acuvue Moist each for one week of daily disposable wear.
Detailed description
The purpose of this cross-over study is to evaluate the clinical performance of the ProClear-1 Day in comparison with 1-Day Acuvue® Moist®. In particular, the study will focus on lens wearing comfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| omafilcon A | Active comparator | Device: omafilcon AStudy participants are randomized to wear omafilcon A lenses. |
| etafilcon A | Active comparator | Device: etafilcon AStudy participants are randomized to wear etafilcon A lenses. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Is between 18 and 40 years of age (inclusive)
- Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study.
- Has had a self-reported visual exam in the last two years
- Is an adapted soft CL (Contact Lens) wearer
- Must be able to wear their lenses at least 6 full days over the 7 days; 14 hours per day, assuming there are no contraindications for doing so
Key exclusion criteria (16 listed)
- Has never worn contact lenses before.
- Currently wears rigid gas permeable contact lenses.
- Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
- Has a CL prescription outside the range of - 1.00 to -6.00D
- Has a spectacle cylinder greater than -0.50D of cylinder in either eye.
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 |
|---|---|---|
| omafilcon AAlso: Proclear 1 Day (omafilcon A)contact lens | Device | omafilcon A |
| etafilcon AAlso: 1-Day Acuvue Moist (etafilcon A)contact lens | Device | etafilcon A |
Primary outcome
Comfort (Subjective Assessment)
Time frame: Baseline
Subjective Assessment of comfort on insertion at baseline for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel)
Comfort (Subjective Assessment)
Time frame: 1 Week
Subjective Assessment: Insertion Comfort, Comfort During Day, Comfort Prior to Removal, Comfort Overall for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel)
Hydration (Subjective Assessment)
Time frame: Baseline
Subjective Assessment of hydration on insertion at baseline for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic)
Hydration (Subjective Assessment)
Time frame: 1 Week
Subjective Assessment: Initial Hydration, Hydration During Day, Hydration Prior to Removal for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic)
Vision Quality (Subjective Assessment)
Time frame: Baseline
Subjective Assessment: Visual quality on insertion at baseline for each pair using questionnaire and rated on subjective response scale (0-10; 0= clear vision, 10=perfectly sharp)
Vision Satisfaction (Subjective Assessment)
Time frame: 1 Week
Subjective Assessment: Vision Satisfaction for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very unsatisfied, 10=very satisfied)
Dryness (Subjective Assessment)
Time frame: 1 Week
Subjective Assessment: Dryness During Day, Dryness Prior to Removal, Overall Dryness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dry, 10=no dryness)
Handling (Subjective Assessment)
Time frame: 1 Week
Subjective Assessment: Handling on Insertion and Removal, Overall Handling for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very difficult, 10=very easy)
Eye Whiteness/Redness (Subjective Assessment)
Time frame: 1 Week
Subjective Assessment: Eye Whiteness/Redness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= significant redness, 10=totally white)
Overall Sensation of Smoothness (Subjective Assessment)
Time frame: 1 Week
Subjective Assessment: Overall sensation of smoothness at 1 week wear for each pair when asked "How would you rate the overall sensation of smoothness (deposit resistance) of the first study lenses, over the last week of wear?" (Likert 1-5; 1=excellent, 2=good, 3=average, 4=below average, 5=poor)
Overall Satisfaction for Lens
Time frame: 1 Week
Subjective Assessment: Satisfaction overall at 1 Week wear for each pair when asked "Overall, how satisfied was the subject with the study lenses, during the last week, with regards to: Overall?" (Likert 1-4; 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 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.
Donald Siegel, OD principal investigator
Sun City West Eye Care
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omafilcon A and etafilcon A in people with Myopia, run by CooperVision, Inc. at 4 sites 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 13 inclusion and 16 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 30 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 4 sites 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 20 Apr 2016). 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?
Comfort (Subjective Assessment) (time frame: Baseline). The study lists 11 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 30 Jul 2020.