MyopiaNCT02406495

Clinical Performance of Habitual Wearers of Bioclear 1-day Lenses When Refitted With Biomedics 1-day Extra for 1 Week

A study testing filcon IV 1 and ocufilcon D in people with Myopia and Hyperopia, run by CooperVision, Inc. at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Open label, 1-week daily disposable, dispensing study Read more about this study

Who is it for?: Ages 18 to 40 years
Conditions the study is for: Myopia, Hyperopia
What is being tested?: filcon IV 1 and ocufilcon D
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteSpain
Study dates: Apr 2015to May 2015
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 Avaira sphere contact lens wearer (at least 1 week in Avaira sphere)
Has a contact lens spherical prescription between + 2.25 to - 8.00 (inclusive)
Has a spectacle cylinder up to 0.75D in each eye.
Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.

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Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
Has clear corneas and no active ocular disease
Has read, understood and signed the information consent letter.
Patient contact lens refraction should fit within the available parameters of the study lenses.
Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
Is willing to comply with the visit schedule

Who cannot join

Is not a habitual wearer of Avaira sphere lenses
Has a CL prescription outside the range of the available parameters of the study lenses.
Has a spectacle cylinder ≥1.00D of cylinder in either eye.
Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
Presence of clinically significant (grade 2-4) anterior segment abnormalities

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Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
Slit lamp findings that would contraindicate contact lens wear such as:
Pathological dry eye or associated findings
Pterygium, pinguecula, or corneal scars within the visual axis
Neovascularization > 0.75 mm in from of the limbus
Giant papillary conjunctivitis (GCP) worse than grade 1
Anterior uveitis or iritis (past or present)
Seborrheic eczema, Seborrheic conjunctivitis
History of corneal ulcers or fungal infections
Poor personal hygiene
Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
Has aphakia, keratoconus or a highly irregular cornea.
Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
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.

Spain1 site

Optometry Research Group (GIO) Optics Department, University of Valencia
Valencia, 46100

Other trials in Spain

About this study

Open label, 1-week daily disposable, dispensing study

Read the detailed description

Evaluate the clinical performance of habitual wearers of FILCON IV 1 sphere lenses when refitted with ocufilcon D asphere for 1 week of daily disposable wear.

Conditions: Myopia, Hyperopia
Being tested: filcon IV 1, ocufilcon D
Medical subject headings: Myopia, Hyperopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

filcon IV 1Device
contact lens
ocufilcon DDevice
contact lens

Study groups in NCT02406495
Study group	Role	What they receive
filcon IV 1 and ocufilcon D	Experimental	Habitual wearers of filcon IV 1 sphere lenses refitted with asphere ocufilcon D lenses. Receives: Device: filcon IV 1; Device: ocufilcon D

What is being measured

The primary outcome is the main question the study is designed to answer.

Lens Fit, Centration - Filcon IV 1 and Ocufilcon D
Lens fit, centration for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale: optimum, decentration acceptable, and decentration unacceptable
Measured: Baseline and 1 Week
Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D
Lens fit, post-blink movement for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week.
(Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Measured: Baseline and 1 Week
Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D
Lens fit, lens tightness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week.
Scale 0%-100% continuous scale 0% - Falls from cornea without lid support 50% - Optimum 100% - No movement
Measured: Baseline and 1 Week
Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D
Lens fit, overall fit acceptance for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0-4, 0=Should not be worn, 4=Perfect.
Measured: Baseline and 1 Week

Secondary outcomes (11)

Visual Acuity - Filcon IV 1 and Ocufilcon D
Visual acuity for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week using logMAR chart (a logMAR of 0.0=20/20 in Snellen notation and negative values indicate better visual acuity).
Measured: Baseline and 1 Week
Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Subjective ratings for comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=could feel, 10=cannot feel).
Measured: Baseline and 1 Week
Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Subjective ratings of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dryness, 10=no dryness).
Measured: Baseline and 1 Week
Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Subjective ratings of handling for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=very difficult to handle, 10=very easy to handle).
Measured: Baseline and 1 Week
Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Subjective ratings of vision satisfaction for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dissatisfied, 10=very satisfied).
Measured: Baseline and 1 Week
Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Subjective ratings of participant's lens preference for either filcon IV 1 or ocufilcon D on comfort, dryness, handling, vision, and overall. Forced choice: filcon IV 1 or ocufilcon D.
Measured: 1 Week
Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D
Lens satisfaction of comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Measured: Baseline and 1 Week
Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D
Lens satisfaction of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Measured: Baseline and 1 Week
Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D
Lens satisfaction of handling forfilcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Measured: Baseline and 1 Week
Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D
Lens satisfaction of vision for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Measured: Baseline and 1 Week
Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D
Lens satisfaction overall for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Measured: Baseline and 1 Week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2015May 2015

First posted2 Apr 2015 (estimated)
Study startApr 2015
Primary completionApr 2015
Study completionMay 2015

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02406495
Sponsor's protocol ID: EX-MKTG-58
Status last verified: Jul 2020
First submitted: 30 Mar 2015
Last updated: 29 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Performance of Habitual Wearers of Bioclear 1-day Lenses When Refitted With Biomedics 1-day Extra for 1 Week
ClinicalTrials.gov ID: NCT02406495
Acronym / sponsor ID: EX-MKTG-58
Conditions: Myopia, Hyperopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2015
Primary completion: Apr 2015 (actual)
Study completion: May 2015 (actual)
First posted: 2 Apr 2015 (estimated)
Results: Posted 3 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Open label, 1-week daily disposable, dispensing study

Detailed description

Evaluate the clinical performance of habitual wearers of FILCON IV 1 sphere lenses when refitted with ocufilcon D asphere for 1 week of daily disposable wear.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
filcon IV 1 and ocufilcon D	Experimental	Device: filcon IV 1, Device: ocufilcon DHabitual wearers of filcon IV 1 sphere lenses refitted with asphere ocufilcon D lenses.

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 Avaira sphere contact lens wearer (at least 1 week in Avaira sphere)
Has a contact lens spherical prescription between + 2.25 to - 8.00 (inclusive)
Has a spectacle cylinder up to 0.75D in each eye.

Key exclusion criteria (21 listed)

Is not a habitual wearer of Avaira sphere lenses
Has a CL prescription outside the range of the available parameters of the study lenses.
Has a spectacle cylinder ≥1.00D of cylinder in either eye.
Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) 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 IV 1contact lens	Device	filcon IV 1 and ocufilcon D
ocufilcon Dcontact lens	Device	filcon IV 1 and ocufilcon D

Primary outcome

Lens Fit, Centration - Filcon IV 1 and Ocufilcon D
Time frame: Baseline and 1 Week
Lens fit, centration for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale: optimum, decentration acceptable, and decentration unacceptable
Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D
Time frame: Baseline and 1 Week
Lens fit, post-blink movement for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D
Time frame: Baseline and 1 Week
Lens fit, lens tightness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0%-100% continuous scale 0% - Falls from cornea without lid support 50% - Optimum 100% - No movement
Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D
Time frame: Baseline and 1 Week
Lens fit, overall fit acceptance for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0-4, 0=Should not be worn, 4=Perfect.

11 secondary outcomes

Visual Acuity - Filcon IV 1 and Ocufilcon D
Time frame: Baseline and 1 Week
Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Time frame: Baseline and 1 Week
Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Time frame: Baseline and 1 Week
Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Time frame: Baseline and 1 Week
Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Time frame: Baseline and 1 Week
Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Time frame: 1 Week
Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D
Time frame: Baseline and 1 Week
Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D
Time frame: Baseline and 1 Week
Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D
Time frame: Baseline and 1 Week
Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D
Time frame: Baseline and 1 Week
Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D
Time frame: Baseline and 1 Week

Results and safety

Results posted to the registry on 3 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall Participants	40	40

Primary outcome: Lens Fit, Centration - Filcon IV 1 and Ocufilcon D

Time frame: Baseline and 1 Week. Number. Unit: percentage of eyes

Measure	Filcon IV 1 OD (Oculus Dexter) n = 40	Filcon IV 1 OS (Oculus Sinister) n = 40	Ocufilcon D OD (Oculus Dexter) n = 40	Ocufilcon D OS (Oculus Sinister) n = 40
Optimum	58	70	98	98
Decentration acceptable	43	30	3	3
Decentration unacceptable	0	0	0	0

Primary outcome: Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D

Time frame: Baseline and 1 Week. Number. Unit: percentage of eyes

Measure	Filcon IV 1 OD n = 40	Filcon IV 1 OS n = 40	Ocufilcon D OD n = 40	Ocufilcon D OS n = 40
0=Insufficient, unacceptable movement	0	0	0	0
1=Minimal, but acceptable movement	10	10	0	0
2=Optimal movement	23	18	10	10
3=Moderate, but acceptable movement	65	70	90	90
4=Excessive, unacceptable movement	3	3	0	0

Primary outcome: Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D

Time frame: Baseline and 1 Week. Mean (Standard Deviation). Unit: percentage of mean lens tightness

Measure	Filcon IV 1 n = 40	Ocufilcon D n = 40
OD	49.1 (5.9)	50.1 (0.79)
OS	48.9 (5.2)	50.0 (1.9)

Primary outcome: Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D

Time frame: Baseline and 1 Week. Number. Unit: percentage of eyes

Measure	Filcon IV 1 OD n = 40	Filcon IV 1 OS n = 40	Ocufilcon D OD n = 40	Ocufilcon D OS n = 40
Should not be worn	0	0	0	0
Borderline but acceptable	0	0	0	0
Min. acceptable	0	0	0	0
Not perfect but OK	38	35	0	0
Perfect	63	65	100	100

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: From dispense up to one week for each study lenses. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Overall Participants	0 of 40 (0%)	0 of 40 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 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.

Robert Montés-Mico, OD MPhil PhD principal investigator

Optometry Research Group (GIO) Optics Department, University of Valencia

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 IV 1 and ocufilcon D in people with Myopia and Hyperopia, run by CooperVision, Inc. at 1 site in Spain.

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 21 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 29 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 Spain. 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 3 May 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?

Lens Fit, Centration - Filcon IV 1 and Ocufilcon D (time frame: Baseline and 1 Week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02406495.

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 29 Jul 2020.