AmetropiaNCT01706770

Evaluation of Enfilcon A Soft Contact Lens When Compared to Galyfilcon A Soft Contact Lens

A study testing enfilcon A and galyfilcon A in people with Ametropia, run by CooperVision, Inc. at 3 sites in United States.

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

The primary objective of thes study is to confirm that the ocular response to the Test lenses are similar to those of the Control lenses when used in a 1 week planned replacement, daily wear modality over a 1-month period. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Ametropia
What is being tested?: enfilcon A and galyfilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 3 sitesUnited States
Study dates: May 2012to Oct 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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Prior to being considered eligible to participate in this study, each subject MUST:
Be at least 18 years of age as of the date of evaluation for the study.
Have read the Informed Consent, been given an explanation of the Informed Consent, indicated understanding of the Informed Consent, signed the Informed Consent document.
Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
Be an adapted, current full-time silicone hydrogel or soft contact lens wearer. An adapted full-time wearer is defined as wearing contact lenses in both eyes on a daily basis for at least 8 hours per day for at least one month prior to participation in the study.
Possess wearable and visually functional eyeglasses.

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Be in good general health, based on his/her knowledge.
Require spectacle lens powers between -1.00 and -6.00 diopters sphere with no more than 2.00 diopters of refractive astigmatism and be willing to wear contact lenses in both eyes.
Have: manifest refraction Snellen visual acuities (VA) equal to or better than 20/25 in each eye.
Upon completing the fitting process with the lenses to be worn in the study, have contact lens Snellen VA equal to or better than 20/30 in each eye.

Who cannot join

Subjects may not be enrolled in this study if any of the following apply: The subject is/has:
Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes. NOTE: Subjects may not wear lenses in a monovision modality at any time during the study as it will interfere with the visual acuity analysis.
Poor personal hygiene.
Any active participation in another clinical trial within 30 days prior to this study.
Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the study period.
A member, relative or household member of the investigator or of the investigational office staff.

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Has a known sensitivity to ingredients used in the care products approved for use in the study.
Previous refractive surgery; or current or previous orthokeratology treatment.
Is aphakic or psuedophakic.
Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermia, keratoconus or type II diabetes.
The need for topical ocular medications or any medication which might interfere with contact lens wear or which would require the lenses to be removed during the day.
The presence of clinically significant (grade 3 or 4) anterior segment abnormalities.
Any; inflammations such as iritis; or any infection or allergic reaction of the eye, lids, or associated structures.
A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections.
A history of papillary conjunctivitis that has interfered with contact lens wear.
Slit lamp findings that would contraindicate contact lens wear, including but not limited to: Pathological dry eye or associated dry eye symptoms with decreased tear levels and punctuate staining > Grade 2, Pterygium, Corneal scars within the visual axis, Neovascularization or ghost vessels > 1.0 mm in from the limbus, Giant papillary conjunctivitis (GPC) of > Grade 1, Anterior uveitis or iritis, Seborrheic eczema, seborrheic conjunctivitis or blepharitis
To be eligible to be randomized for study product a subject must have ALL of the Inclusion Criteria and have NONE of the exclusion criteria present.
To be eligible for lens dispensing (either Test or Control), the subject's study lens contact lens visual acuity must be equal to or better than 20/30 in each eye.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Vision Care Associates
East Lansing, Michigan, 48823
Advanced Eyecare
Pismo Beach, California, 93449
Eric M. White, OD, Inc.
San Diego, California, 48823

Other trials in United States

About this study

Official title: Evaluation of Enfilcon A Soft Contact Lens Compared to Galyfilcon A Soft Contact Lens

Read the detailed description

The test lens and control lens were randomized in a 2:1 ratio to evaluate the test lens and control contact lens.

Conditions: Ametropia
Being tested: enfilcon A, galyfilcon A
Medical subject headings: Refractive Errors

What participants receive

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

enfilcon ADevice
Also called Avaira® Toric
galyfilcon ADevice
Also called Acvuve® Advance®

Study groups in NCT01706770
Study group	Role	What they receive
enfilcon A	Experimental	The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality. Receives: Device: enfilcon A
galyfilcon A	Active comparator	The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality. Receives: Device: galyfilcon A

What is being measured

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

Objective Assessment: Ocular Response - Biomicroscopy
The primary safety endpoint are the objective slit lamp findings associated with the enfilcon A contact lenses compared with those same findings reported as associated with the galyfilcon A contact lenses.
The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline/Dispensing (baseline and dispensing visit combined), Post-Dispensing (after lenses were dispensed and allowed to settle) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit combined). The average grade for unique eyes with findings greater than 0 (none) is compared.
Measured: Change from baseline/dispensing visits, post-dispensing visit and all follow-ups visits
Comparison of Objective Findings - Number of Adverse Events in Unique Eyes
The primary safety endpoint are the objective findings of the number of adverse events in unique eyes associated with the enfilcon A contact lenses compared with those same findings as associated with the galyfilcon A contact lenses.
The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence from Baseline through end of month 1 visit.
Measured: Any occurrence from baseline to 1 month visit

Timeline

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

May 2012Oct 2012

First posted15 Oct 2012 (estimated)
Study startMay 2012
Primary completionJul 2012
Study completionOct 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 AmetropiaStudies 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: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01706770
Sponsor's protocol ID: FC111216
Status last verified: Sep 2020
First submitted: 5 Oct 2012
Last updated: 5 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

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 Ametropia trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Enfilcon A Soft Contact Lens Compared to Galyfilcon A Soft Contact Lens
ClinicalTrials.gov ID: NCT01706770
Acronym / sponsor ID: FC111216
Conditions: Ametropia
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: May 2012
Primary completion: Jul 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 15 Oct 2012 (estimated)
Results: Posted 29 Apr 2014

Clinical summary

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

Detailed description

The test lens and control lens were randomized in a 2:1 ratio to evaluate the test lens and control contact lens.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
enfilcon A	Experimental	Device: enfilcon AThe test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
galyfilcon A	Active comparator	Device: galyfilcon AThe control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Be at least 18 years of age as of the date of evaluation for the study.
Have read the Informed Consent, been given an explanation of the Informed Consent, indicated understanding of the Informed Consent, signed the Informed Consent document.
Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
Be an adapted, current full-time silicone hydrogel or soft contact lens wearer. An adapted full-time wearer is defined as wearing contact lenses in both eyes on a daily basis for at least 8 hours per day for at least one month prior to participation in the study.
Possess wearable and visually functional eyeglasses.

Key exclusion criteria (18 listed)

Subjects may not be enrolled in this study if any of the following apply: The subject is/has:
Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes. NOTE: Subjects may not wear lenses in a monovision modality at any time during the study as it will interfere with the visual acuity analysis.
Poor personal hygiene.
Any active participation in another clinical trial within 30 days prior to this study.
Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the study period.

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
enfilcon AAlso: Avaira® Toric	Device	enfilcon A
galyfilcon AAlso: Acvuve® Advance®	Device	galyfilcon A

Primary outcome

Objective Assessment: Ocular Response - Biomicroscopy
Time frame: Change from baseline/dispensing visits, post-dispensing visit and all follow-ups visits
The primary safety endpoint are the objective slit lamp findings associated with the enfilcon A contact lenses compared with those same findings reported as associated with the galyfilcon A contact lenses. The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline/Dispensing (baseline and dispensing visit combined), Post-Dispensing (after lenses were dispensed and allowed to settle) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit combined). The average grade for unique eyes with findings greater than 0 (none) is compared.
Comparison of Objective Findings - Number of Adverse Events in Unique Eyes
Time frame: Any occurrence from baseline to 1 month visit
The primary safety endpoint are the objective findings of the number of adverse events in unique eyes associated with the enfilcon A contact lenses compared with those same findings as associated with the galyfilcon A contact lenses. The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence from Baseline through end of month 1 visit.

Results and safety

Results posted to the registry on 29 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Enfilcon A	33	31
Galyfilcon A	17	17

Primary outcome: Objective Assessment: Ocular Response - Biomicroscopy

Time frame: Change from baseline/dispensing visits, post-dispensing visit and all follow-ups visits. Mean (Full Range). Unit: units on a scale

Measure	Enfilcon A n = 31	Galyfilcon A n = 17
Epithelial Edema, Baseline/Dispensing	1.00 (1 to 1)	NA (0 to 0)
Epithelial Edema, Post-Dispensing	NA (0 to 0)	NA (0 to 0)
Epithelial Edema, All Follow-up	NA (0 to 0)	NA (0 to 0)
Stromal Edema, Basline/Dispensing	NA (0 to 0)	NA (0 to 0)
Stromal Edema, Post-Dispensing	NA (0 to 0)	NA (0 to 0)
Stromal Edema, All Follow-up	NA (0 to 0)	NA (0 to 0)
Neovascularization, Baseline/Dispensing	1.00 (1 to 1)	1.00 (1 to 1)
Neovascularization, Post-Dispensing	NA (0 to 0)	1.00 (1 to 1)

Population analysed: Unique eyes are defined as each individual eye in the study and are only counted once for each of the visit groupings.

Primary outcome: Comparison of Objective Findings - Number of Adverse Events in Unique Eyes

Time frame: Any occurrence from baseline to 1 month visit. Number. Unit: number of adverse events

Measure	Enfilcon A n = 31	Galyfilcon A n = 17
Value	0	2

Population analysed: Unique eyes are defined as each individual eye in the study.

Adverse events

Time frame: From dispense up to one month on both the study lenses, a total of two months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enfilcon A	0 of 33 (0%)	0 of 33 (0%)	0 of 33
Galyfilcon A	0 of 17 (0%)	1 of 17 (5.9%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Active, not recruiting
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Not yet recruiting
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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.

Scott E Schachter, OD principal investigator

Unafiliated

Cheryl Vincent-Reimer, OD principal investigator

Unafiliated

Eric White, OD principal investigator

Unafiliated

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing enfilcon A and galyfilcon A in people with Ametropia, run by CooperVision, Inc. at 3 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 10 inclusion and 18 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 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 29 Apr 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?

Objective Assessment: Ocular Response - Biomicroscopy (time frame: Change from baseline/dispensing visits, post-dispensing visit and all follow-ups visits). 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?

On the ClinicalTrials.gov record for NCT01706770.

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 5 Oct 2020.