MyopiaNCT01464255
Comparative Study of Two Marketed 1-day Soft Contact Lenses
A study testing ocufilcon D and ocufilcon B in people with Myopia, run by CooperVision, Inc. at 1 site in United States.
Trial summary
This study is designed to evaluate ocufilcon D lens compared to ocufilcon B lens in a 1-week crossover, daily wear regimen. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Myopia
- What is being tested?
- ocufilcon D and ocufilcon B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Nov 2011
- 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
- Has had a self reported oculo-visual examination in the last two years.
- Is able to wear the study lenses for at least eight hours a day, seven days a week
- Aged 18-40 years and has full legal capacity as a volunteer
- Has a distance contact lens prescription from -0.25 and -6.00D inclusive
- Has spectacle astigmatism of < 1.00D in each eye
- Baseline vision of 20/20 best-corrected in each eye.
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- Is correctable to at least 20/25 distance visual acuity with study contact lenses in each eye
- Has read and understood the consent form and willing to sign consent form
- Willing and able to follow participant instructions and attend the required study visits Has worn soft contact lenses for at least two weeks prior to the study (daily wear only).
Who cannot join
- Currently wears contact lenses on an extended wear basis.
- Not a current or past wearer of the ocufilcon B 52% 1-day lenses.
- Has undergone anterior ocular surgery
- Is aphakic
- Has never worn contact lenses before
- Has any systemic disease which clinically contraindicates contact lenses
Show all 13Show fewer
- Has active ocular disease or severe insufficiency of lacrimal secretion (dry eye)
- Use of systemic or topical medications that will affect ocular health or visual performance
- Slit lamp findings with a grading of greater than 1.0 using the grading scales in Appendix 3
- Not possible to achieve a satisfactory fit with the lens design used in the study
- Has keratoconus or other corneal irregularity
- Participating in another eye-related clinical trial
- Pregnant, lactating or planning a pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Center, U.C. Berkeley, School of Optometry
Berkeley, California, 94720-
About this study
Official title: Clinical Performance of Ocufilcon D With a Wetting Agent to Ocufilcon B
This study is designed to evaluate ocufilcon D lens compared to ocufilcon B lens in a 1-week crossover, daily wear regimen.
Read the detailed description
This study is designed to evaluate 2 daily disposable contact lenses that are both currently cleared for the USA market. Study of the ocufilcon D lens compared to the ocufilcon B lens in a 1-week crossover, daily wear regimen. The primary objective is the comparison of fitting characteristics. The secondary objective is the comparison of comfort, end of day comfort and dryness measures.
- Conditions
- Myopia
- Being tested
- ocufilcon D, ocufilcon B
- Keywords
- contact lenses
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ocufilcon DDevice
Also called oculfilcon D (Daily wear soft contact lens)
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
ocufilcon BDevice
Also called oculfilcon B (Daily wear soft contact lens)
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
| Study group | Role | What they receive |
|---|---|---|
| ocufilcon D | Experimental | Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week. Receives: Device: ocufilcon B |
| ocufilcon B | Active comparator | Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week. Receives: Device: ocufilcon D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lens Fit - Decentration After Insertion
The ophthalmologist's objective assessment of lens fit measurement of decentration after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (mm, horizontal and vertical).
Measured: Baseline and 7 days from baseline visit
Lens Fit - Decentration at One Week
The ophthalmologist's objective assessment of lens fit measurement of decentration of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). Each pair worn for one week daily disposable wear basis (at least 8 hours per day, 7 days per week). Lenses worn minimum 2 hours prior to visit. (mm, horizontal and vertical).
Measured: 7 days and 14 days from baseline visit
Lens Fit - Tightness After Insertion
The ophthalmologist's rating of lens fit measurement of push-up tightness after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (0-100%, 5% steps, 0%=excessively loose, 50%=optimum, 100%=excessively tight ).
Measured: Baseline and 7 days from baseline visit
Lens Fit - Tightness at One Week
The ophthalmologist's rating of lens fit measurement of push-up tightness of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). Each pair worn for one week daily disposable wear basis (at least 8 hours per day, 7 days per week). Lenses worn minimum 2 hours prior to visit. (0-100%, 5% steps, 0%=excessively loose, 50%=optimum, 100%=excessively tight ).
Measured: 7 days and 14 days from baseline visit
Lens Fit - Post-Blink Lens Movement After Insertion
The ophthalmologist's objective assessment of lens fit measurement of post-blink lens movement after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (mm).
Measured: Baseline and 7 days from baseline visit
Lens Fit - Post-Blink Lens Movement Prior to Removal
The ophthalmologist's objective assessment of lens fit measurement of post-blink lens movement prior to removal of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). (mm).
Measured: 7 days and 14 days from baseline visit
Secondary outcomes (7)
Overall Preference - Comfort After Insertion
Participant's subjective rating for overall preference of lens comfort immediately after insertion for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.
Measured: 14 days from baseline visit
Overall Preference - Comfort Before Removal
Participant's subjective rating for overall preference of lens comfort immediately before removal for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.
Measured: 14 days from baseline visit
Overall Preference - Dryness After Insertion
Participant's subjective rating for overall preference of lens dryness immediately after insertion for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.
Measured: 14 days from baseline visit
Overall Preference - Dryness Before Removal
Participant's subjective rating for overall preference of lens dryness immediately before removal for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.
Measured: 14 days from baseline visit
Overall Preference - Handling, Inserting
Participant's subjective rating for overall preference of lens ease of handling at inserting for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.
Measured: 14 days from baseline visit
Overall Preference - Handling, Removing
Participant's subjective rating for overall preference of lens ease of handling at removing for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.
Measured: 14 days from baseline visit
Overall Lens Pair Preference
Participant's subjective rating for overall preference for lens pair #1 or Pair #2 based on comfort, vision and handling. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.
Measured: 14 days from baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2011
- Study completionNov 2011
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thao N Yeh, OD, Principal investigator, U.C. Berkeley, School of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464255
- Sponsor's protocol ID
- CV-OMC-01
- Status last verified
- Aug 2014
- First submitted
- 26 Oct 2011
- Last updated
- 19 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Ocufilcon D With a Wetting Agent to Ocufilcon B
- ClinicalTrials.gov ID
- NCT01464255
- Acronym / sponsor ID
- CV-OMC-01
- Conditions
- Myopia
- Keywords
- contact lenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 3 Nov 2011 (estimated)
- Results
- Posted 19 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate ocufilcon D lens compared to ocufilcon B lens in a 1-week crossover, daily wear regimen.
Detailed description
This study is designed to evaluate 2 daily disposable contact lenses that are both currently cleared for the USA market. Study of the ocufilcon D lens compared to the ocufilcon B lens in a 1-week crossover, daily wear regimen. The primary objective is the comparison of fitting characteristics. The secondary objective is the comparison of comfort, end of day comfort and dryness measures.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ocufilcon D | Experimental | Device: ocufilcon BParticipants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week. |
| ocufilcon B | Active comparator | Device: ocufilcon DParticipants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Has had a self reported oculo-visual examination in the last two years.
- Is able to wear the study lenses for at least eight hours a day, seven days a week
- Aged 18-40 years and has full legal capacity as a volunteer
- Has a distance contact lens prescription from -0.25 and -6.00D inclusive
- Has spectacle astigmatism of < 1.00D in each eye
Key exclusion criteria (13 listed)
- Currently wears contact lenses on an extended wear basis.
- Not a current or past wearer of the ocufilcon B 52% 1-day lenses.
- Has undergone anterior ocular surgery
- Is aphakic
- Has never worn contact lenses before
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 |
|---|---|---|
| ocufilcon DAlso: oculfilcon D (Daily wear soft contact lens)Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week. | Device | ocufilcon B |
| ocufilcon BAlso: oculfilcon B (Daily wear soft contact lens)Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week. | Device | ocufilcon D |
Primary outcome
Lens Fit - Decentration After Insertion
Time frame: Baseline and 7 days from baseline visit
The ophthalmologist's objective assessment of lens fit measurement of decentration after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (mm, horizontal and vertical).
Lens Fit - Decentration at One Week
Time frame: 7 days and 14 days from baseline visit
The ophthalmologist's objective assessment of lens fit measurement of decentration of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). Each pair worn for one week daily disposable wear basis (at least 8 hours per day, 7 days per week). Lenses worn minimum 2 hours prior to visit. (mm, horizontal and vertical).
Lens Fit - Tightness After Insertion
Time frame: Baseline and 7 days from baseline visit
The ophthalmologist's rating of lens fit measurement of push-up tightness after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (0-100%, 5% steps, 0%=excessively loose, 50%=optimum, 100%=excessively tight ).
Lens Fit - Tightness at One Week
Time frame: 7 days and 14 days from baseline visit
The ophthalmologist's rating of lens fit measurement of push-up tightness of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). Each pair worn for one week daily disposable wear basis (at least 8 hours per day, 7 days per week). Lenses worn minimum 2 hours prior to visit. (0-100%, 5% steps, 0%=excessively loose, 50%=optimum, 100%=excessively tight ).
Lens Fit - Post-Blink Lens Movement After Insertion
Time frame: Baseline and 7 days from baseline visit
The ophthalmologist's objective assessment of lens fit measurement of post-blink lens movement after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (mm).
Lens Fit - Post-Blink Lens Movement Prior to Removal
Time frame: 7 days and 14 days from baseline visit
The ophthalmologist's objective assessment of lens fit measurement of post-blink lens movement prior to removal of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). (mm).
7 secondary outcomes
Overall Preference - Comfort After Insertion
Time frame: 14 days from baseline visit
Overall Preference - Comfort Before Removal
Time frame: 14 days from baseline visit
Overall Preference - Dryness After Insertion
Time frame: 14 days from baseline visit
Overall Preference - Dryness Before Removal
Time frame: 14 days from baseline visit
Overall Preference - Handling, Inserting
Time frame: 14 days from baseline visit
Overall Preference - Handling, Removing
Time frame: 14 days from baseline visit
Overall Lens Pair Preference
Time frame: 14 days from baseline visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2014.
- 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.
Thao N Yeh, OD principal investigator
U.C. Berkeley, School of Optometry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ocufilcon D and ocufilcon B 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 9 inclusion and 13 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 19 Aug 2014. 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 19 Aug 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?
Lens Fit - Decentration After Insertion (time frame: Baseline and 7 days from baseline visit). The study lists 6 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 19 Aug 2014.