MyopiaNCT02097030
Clinical Evaluation of Daily Disposable Contact Lenses
A study testing filcon II 3, etafilcon A and nelfilcon A in people with Myopia, run by CooperVision, Inc. at 1 site in United States.
Trial summary
The objective of the study is to compare the overall subjective preference of filcon II 3 daily disposable silicone hyrogel contact lenses compared to etafilcon A and nelfilcon A daily disposable conventional hydrogel contact lenses. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Myopia
- What is being tested?
- filcon II 3, etafilcon A and nelfilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Apr 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
- Is between 18 and 40 years of age (inclusive)
- Has had a self-reported visual exam in the last two years
- Is an adapted soft CL wearer
- Must be able to wear their lenses at least 3 full days, 10 hours per day, assuming there are no contraindications for doing so
- Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
- Has less than 1.25 D spectacle cylinder in each eye.
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- Baseline vision of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
- Is correctable to at least 20/25 distance visual acuity with study contact lenses in each eye
- 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 3 full days)
- Is willing to comply with the visit schedule
Who cannot join
- Has never worn contact lenses before.
- Currently wears rigid gas permeable contact lenses.
- Has a history of not achieving comfortable CL wear (3 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 -1.25D of cylinder in either eye.
- Has best corrected spectacle distance vision worse then 20/25 in either eye.
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- Has any systemic disease affecting ocular health.
- Is using any systemic or topical medications, (includes rewetting drops, artificial tears and allergy drops), that will affect ocular health. Occasional use is acceptable but not during the trial.
- 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
1 site in 1 country.
United States1 site
University of California, Berkeley Clinical Research Center (UCB-CRC)
Berkeley, California, 94720-2020
About this study
Official title: Single-Center Clinical Evaluation of Daily Disposable Contact Lenses
The objective of the study is to compare the overall subjective preference of filcon II 3 daily disposable silicone hyrogel contact lenses compared to etafilcon A and nelfilcon A daily disposable conventional hydrogel contact lenses.
Read the detailed description
Double-masked, randomised, controlled crossover trial. Subjects were randomized to wear one or the other of the conventional hydriogel lenses; all subjects wore the filcon II 3 lenses. The first randomly assigned lens type was worn for 3 days, with daily replacement, followed by 3 days of wear of the other lens type, with daily replacement.
- Conditions
- Myopia
- Being tested
- filcon II 3, etafilcon A, nelfilcon A
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filcon II 3Device
Also called Silicone Hydrogel Daily Disposable Contact Lens
Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.
etafilcon ADevice
Also called Hydrogel Daily Disposable Contact Lens
Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.
nelfilcon ADevice
Also called Hydrogel Daily Disposable Contact Lens
Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.
| Study group | Role | What they receive |
|---|---|---|
| etafilcon A lens | Active comparator | Participants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types. Receives: Device: etafilcon A |
| nelfilcon A lens | Active comparator | Participants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types. Receives: Device: nelfilcon A |
| filcon II 3 lens | Active comparator | Participants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types. Receives: Device: filcon II 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Lens Preference - All Study Lenses
Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair of lenses. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).
Measured: Study Exit
Overall Lens Preference - Hydrogel vs. Filcon II 3
Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).
Measured: Study Exit
Secondary outcomes (17)
Subjective Response for Comfort
Participant's subjective response for comfort measured at baseline and 3 day follow-up. (Continuous Comfort Scale 0-100, 0=cannot be worn/causes pain, 100=cannot be felt ever)
Measured: Baseline and 3 day follow-up
Subjective Response for Vision
Participant's subjective response for vision measured at baseline and at 3 day follow-up of daily disposable wear of lenses. (Vision Scale 0-100, 0=very blurry, 100=very clear).
Measured: Baseline and 3 day follow-up
Subjective Response for Insertion
Participant's subjective response for insertion measured at baseline. (Insertion Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).
Measured: Baseline
Subjective Response for Handling (Insertion and Removal)
Participant's subjective response for handling (insertion and removal) measured at 3 day follow-up of daily disposable wear of lenses. (Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).
Measured: 3 days follow-up
Subjective Response for Dryness
Participant's subjective response for dryness, measured at baseline and after 3 day follow-up of daily disposable wear of lenses. (Dryness Scale 0-100, 0=Cannot be worn/extremely dry, 100=no dryness experienced at any time).
Measured: 3 Days Follow-up
Overall Satisfaction, Vision
Participant's subjective response for overall vision satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.
Measured: 3 Days Follow-up
Overall Satisfaction, Comfort
Participant's subjective response for overall comfort satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.
Measured: 3 Days Follow-up
Overall Satisfaction, Handling
Participant's subjective response for overall handling satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.
Measured: 3 Days
Overall Satisfaction, Dryness
Participant's subjective response for overall dryness satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.
Measured: 3 Days Follow-up
Overall Satisfaction
Participant's subjective response for overall satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.
Measured: 3 Days Follow-up
Lens Fit and Performance - Wettability (Baseline and 3 Days Follow-up)
The investigator's objective assessment for contact lens fit and performance - wettability. Measured at baseline (10-15mins settling) for both study pairs. Wettability (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced).
Measured: Baseline and 3 days follow-up
Lens Fit and Performance - Deposits (Baseline and 3 Days Follow-up)
The investigator's objective assessment for contact lens fit and performance - deposits. Measured at baseline (10-15mins settling) for both study pairs. Deposits (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced);
Measured: Baseline and 3 days follow-up
Lens Fit and Performance - Debris (Baseline and 3 Day Follow-up)
The investigator's objective assessment for contact lens fit and performance - debris. Measured at baseline (10-15mins settling) for both study pairs. (Debris scale 0-4; 0.25 steps; 0=no debris, 4=significant debris)
Measured: Baseline and 3 day follow-up
Lens Fit and Performance - Movement (Baseline and 3 Days Follow-up)
The investigator's objective assessment for contact lens fit and performance - movement. Measured at baseline (10-15mins settling) for both study pairs. Movement (scale in millimeters).
Measured: Baseline and 3 days follow-up
Lens Fit and Performance - Fit Acceptance
The investigator's objective assessment for contact lens fit and performance - fit acceptance. Measured at baseline and 3 day follow-up (10-15mins settling) for both study pairs. Fit acceptance (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect).
Measured: Baseline and 3 day follow-up
Lens Fit and Performance - Tightness (Baseline and 3 Day Follow-up)
The investigator's objective assessment for contact lens fit and performance - tightness. Measured at baseline (10-15mins settling) for both study pairs. Tightness (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect).
Measured: Baseline and 3 day follow-up
Ocular Health - Biomicroscopy
The investigator's objective assessment of ocular health assessed for each study Pair after 3 days wear by biomicroscopy. Bulbar and Limbal Hyperemia; Corneal Staining Type, Extent and Depth, Conjunctival Staining and Indentation. BrienHolden Vision Institute Continuous Scale: 1-4, 0.5 steps (1=Very, 2=Slight, 3=Moderate, 4=Severe)
Measured: 3 Days Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2014
- Study completionApr 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Meng C Lin, OD, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097030
- Sponsor's protocol ID
- EX-MKTG-46
- Status last verified
- Jul 2020
- First submitted
- 24 Mar 2014
- Last updated
- 31 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 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Center Clinical Evaluation of Daily Disposable Contact Lenses
- ClinicalTrials.gov ID
- NCT02097030
- Acronym / sponsor ID
- EX-MKTG-46
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Posted 15 Feb 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 the study is to compare the overall subjective preference of filcon II 3 daily disposable silicone hyrogel contact lenses compared to etafilcon A and nelfilcon A daily disposable conventional hydrogel contact lenses.
Detailed description
Double-masked, randomised, controlled crossover trial. Subjects were randomized to wear one or the other of the conventional hydriogel lenses; all subjects wore the filcon II 3 lenses. The first randomly assigned lens type was worn for 3 days, with daily replacement, followed by 3 days of wear of the other lens type, with daily replacement.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| etafilcon A lens | Active comparator | Device: etafilcon AParticipants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types. |
| nelfilcon A lens | Active comparator | Device: nelfilcon AParticipants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types. |
| filcon II 3 lens | Active comparator | Device: filcon II 3Participants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Is between 18 and 40 years of age (inclusive)
- Has had a self-reported visual exam in the last two years
- Is an adapted soft CL wearer
- Must be able to wear their lenses at least 3 full days, 10 hours per day, assuming there are no contraindications for doing so
- Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
Key exclusion criteria (15 listed)
- Has never worn contact lenses before.
- Currently wears rigid gas permeable contact lenses.
- Has a history of not achieving comfortable CL wear (3 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 -1.25D 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 |
|---|---|---|
| filcon II 3Also: Silicone Hydrogel Daily Disposable Contact LensParticipants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days. | Device | filcon II 3 lens |
| etafilcon AAlso: Hydrogel Daily Disposable Contact LensParticipants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days. | Device | etafilcon A lens |
| nelfilcon AAlso: Hydrogel Daily Disposable Contact LensParticipants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days. | Device | nelfilcon A lens |
Primary outcome
Overall Lens Preference - All Study Lenses
Time frame: Study Exit
Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair of lenses. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).
Overall Lens Preference - Hydrogel vs. Filcon II 3
Time frame: Study Exit
Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).
17 secondary outcomes
Subjective Response for Comfort
Time frame: Baseline and 3 day follow-up
Subjective Response for Vision
Time frame: Baseline and 3 day follow-up
Subjective Response for Insertion
Time frame: Baseline
Subjective Response for Handling (Insertion and Removal)
Time frame: 3 days follow-up
Subjective Response for Dryness
Time frame: 3 Days Follow-up
Overall Satisfaction, Vision
Time frame: 3 Days Follow-up
Overall Satisfaction, Comfort
Time frame: 3 Days Follow-up
Overall Satisfaction, Handling
Time frame: 3 Days
Overall Satisfaction, Dryness
Time frame: 3 Days Follow-up
Overall Satisfaction
Time frame: 3 Days Follow-up
Lens Fit and Performance - Wettability (Baseline and 3 Days Follow-up)
Time frame: Baseline and 3 days follow-up
Lens Fit and Performance - Deposits (Baseline and 3 Days Follow-up)
Time frame: Baseline and 3 days follow-up
Lens Fit and Performance - Debris (Baseline and 3 Day Follow-up)
Time frame: Baseline and 3 day follow-up
Lens Fit and Performance - Movement (Baseline and 3 Days Follow-up)
Time frame: Baseline and 3 days follow-up
Lens Fit and Performance - Fit Acceptance
Time frame: Baseline and 3 day follow-up
Lens Fit and Performance - Tightness (Baseline and 3 Day Follow-up)
Time frame: Baseline and 3 day follow-up
Ocular Health - Biomicroscopy
Time frame: 3 Days Follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 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.
Meng C Lin, OD, PhD principal investigator
University of California, Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing filcon II 3, etafilcon A and nelfilcon 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 12 inclusion and 15 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 31 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 15 Feb 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?
Overall Lens Preference - All Study Lenses (time frame: Study Exit). The study lists 2 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 31 Jul 2020.