AstigmatismNCT02921412

Performance of Fanfilcon A Toric Lenses After at Least One Month Wearing Enfilcon A Toric Lenses

A study testing fanfilcon A in people with Astigmatism, run by CooperVision, Inc. at 4 sites in United States.

Completed

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

Trial summary

This is a prospective, multi-center, subject-masked, bilateral, daily wear, two-month dispensing study Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Astigmatism
What is being tested?: fanfilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 4 sitesUnited States
Study dates: 1 Oct 2016to 21 Mar 2017
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
Healthy volunteers accepted
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)
Has had a self-reported eye exam in the last two years
Is a habitual soft toric lens wearer
Can be successfully fit with study lenses (≥ grade 2 fit acceptance)
Has a contact lens spherical prescription between -1.00 to -6.00D with a cylinder between -0.75 and -1.75D (Diopters) (inclusive)

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Has a spectacle cylinder of at least 0.75D in each eye.
Can achieve best corrected spectacle refraction distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
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
Has a contact lens refraction that fits 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

A person will be excluded from the study if he/she:
Has a history of not achieving comfortable CL (Contact Lens) wear (5 days per week; > 8 hours/day)
Presents with clinically significant anterior segment abnormalities
Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear
Presents with slit lamp findings that would contraindicate contact lens wear such as:
Pathological dry eye or associated findings

Show all 18Show fewer

Significant pterygium, pinguecula, or corneal scars within the visual axis
Neovascularization > 0.75 mm in from of the limbus
Anterior uveitis or iritis (or history in past year)
Seborrheic eczema of eyelid region, 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.
Is frequently using rewetting/ lubricating eye drops (more than once per day)

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Debbie Kim
Closter, New Jersey, 07624
Hospital Contact Lens Service
Miami, Florida, 33136
West Village Eyecare
New York, New York, 10014
Spokane Eye Clinic
Spokane, Washington, 99204

Other trials in United States

About this study

This is a prospective, multi-center, subject-masked, bilateral, daily wear, two-month dispensing study

Read the detailed description

The aim of this study is to determine if adapted contact lens wearers enfilcon A toric lenses can be confidently refit into fanfilcon A toric lenses and can be successful after one month of daily wear.

Conditions: Astigmatism
Being tested: fanfilcon A
Medical subject headings: Astigmatism

What participants receive

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

fanfilcon ADevice
contact lens

Study groups in NCT02921412
Study group	Role	What they receive
enfilcon A (habitual)	No intervention	All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses.
fanfilcon A	Active comparator	All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses. Receives: Device: fanfilcon A

What is being measured

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

Visual Acuity
High contrast distance visual acuity is measured by LogMAR.
Measured: baseline, 2 weeks, 1 month
Centration
Lens centration is assessed (optimum, decentration acceptable, decentration unacceptable).
Measured: baseline, 2 weeks, 1 month
Corneal Coverage
Corneal coverage will be assessed (yes/no)
Measured: baseline, 2 weeks, 1 month
Post-blink Movement
Post-blink lens movement assessed using the following evaluations (0-4): 0=Insufficient, unacceptable, 1=Minimal, acceptable, 2=Optimal, 3=Moderate, acceptable, 4=Excessive, unacceptable)
Measured: baseline, 2 weeks, 1 month
Fit Acceptability
Investigator fit acceptability for each lens pair. Scale 0-4: (0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)
Measured: baseline, 2 weeks, 1 month

Timeline

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

1 Oct 201621 Mar 2017

First posted3 Oct 2016 (estimated)
Study start1 Oct 2016
Primary completion1 Feb 2017
Study completion21 Mar 2017

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 AstigmatismStudies 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: Non-randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02921412
Sponsor's protocol ID: EX-MKTG-67
Status last verified: Mar 2018
First submitted: 29 Sep 2016
Last updated: 10 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: 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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Clinical Performance and Outcomes After Toric Lens Transition
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The EYERISING Study
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P1 Toric Vs. Max 1day
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Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
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Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism

All Astigmatism trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Performance of Fanfilcon A Toric Lenses After at Least One Month Wearing Enfilcon A Toric Lenses
ClinicalTrials.gov ID: NCT02921412
Acronym / sponsor ID: EX-MKTG-67
Conditions: Astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 1 Oct 2016 (actual)
Primary completion: 1 Feb 2017 (actual)
Study completion: 21 Mar 2017 (actual)
First posted: 3 Oct 2016 (estimated)
Results: Posted 13 Mar 2018

Clinical summary

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

This is a prospective, multi-center, subject-masked, bilateral, daily wear, two-month dispensing study

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
enfilcon A (habitual)	No intervention	–All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses.
fanfilcon A	Active comparator	Device: fanfilcon AAll participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (14 listed)

Is between 18 and 40 years of age (inclusive)
Has had a self-reported eye exam in the last two years
Is a habitual soft toric lens wearer
Can be successfully fit with study lenses (≥ grade 2 fit acceptance)
Has a contact lens spherical prescription between -1.00 to -6.00D with a cylinder between -0.75 and -1.75D (Diopters) (inclusive)

Key exclusion criteria (18 listed)

Has a history of not achieving comfortable CL (Contact Lens) wear (5 days per week; > 8 hours/day)
Presents with clinically significant anterior segment abnormalities
Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear
Presents with slit lamp findings that would contraindicate contact lens wear such as:
Has a known history of corneal hypoesthesia (reduced corneal sensitivity)

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
fanfilcon Acontact lens	Device	fanfilcon A

Primary outcome

Visual Acuity
Time frame: baseline, 2 weeks, 1 month
High contrast distance visual acuity is measured by LogMAR.
Centration
Time frame: baseline, 2 weeks, 1 month
Lens centration is assessed (optimum, decentration acceptable, decentration unacceptable).
Corneal Coverage
Time frame: baseline, 2 weeks, 1 month
Corneal coverage will be assessed (yes/no)
Post-blink Movement
Time frame: baseline, 2 weeks, 1 month
Post-blink lens movement assessed using the following evaluations (0-4): 0=Insufficient, unacceptable, 1=Minimal, acceptable, 2=Optimal, 3=Moderate, acceptable, 4=Excessive, unacceptable)
Fit Acceptability
Time frame: baseline, 2 weeks, 1 month
Investigator fit acceptability for each lens pair. Scale 0-4: (0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)

Results and safety

Results posted to the registry on 13 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants (Enfilcon A Toric / Fanfilcon A Toric Lenses)	36	36

Primary outcome: Visual Acuity

Time frame: baseline, 2 weeks, 1 month. Mean (Standard Deviation). Unit: logMAR

Measure	Enfilcon A Toric (Baseline) n = 36	Fanfilcon A Toric (Dispense) n = 36	Fanfilcon A Toric (2 Weeks) n = 35	Fanfilcon A Toric (1 Month) n = 35
Value	-0.05 (0.05)	-0.05 (0.05)	-0.05 (0.05)	-0.04 (0.04)

Population analysed: Analysis was performed prior to one participant completing the 2 week and 1 month visits.

Primary outcome: Centration

Time frame: baseline, 2 weeks, 1 month. Count of participants. Unit: Participants

Measure	Enfilcon A Toric (Baseline) n = 36	Fanfilcon A Toric (Dispense) n = 36	Fanfilcon A Toric (2 Weeks) n = 35	Fanfilcon A Toric (1 Month) n = 35
Optimum	34	35	30	33
Acceptable	1	1	5	2
Unacceptable	1	0	0	0

Population analysed: Analysis was performed prior to one participant completing the 2 week and 1 month visits.

Primary outcome: Corneal Coverage

Time frame: baseline, 2 weeks, 1 month. Count of participants. Unit: Participants

Measure	Enfilcon A Toric (Baseline) n = 36	Fanfilcon A Toric (Dispense) n = 36	Fanfilcon A Toric (2 Weeks) n = 35	Fanfilcon A Toric (1 Month) n = 35
Yes	36	36	35	35
No	0	0	0	0

Population analysed: Analysis was performed prior to one participant completing the 2 week and 1 month visits.

Primary outcome: Post-blink Movement

Time frame: baseline, 2 weeks, 1 month. Mean (Standard Deviation). Unit: units on a scale

Measure	Enfilcon A Toric (Baseline) n = 36	Fanfilcon A Toric (Dispense) n = 36	Fanfilcon A Toric (2 Weeks) n = 35	Fanfilcon A Toric (1 Month) n = 35
Value	1.83 (0.51)	1.92 (0.50)	1.69 (0.47)	1.86 (0.49)

Population analysed: Analysis was performed prior to one participant completing the 2 week and 1 month visits.

Adverse events

Time frame: Adverse event data collected at all scheduled visits over a 1 month period of time. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants (Enfilcon A Toric / Fanfilcon A Toric Lenses)	0 of 36 (0%)	0 of 36 (0%)	0 of 36

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Astigmatism

Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
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Recruiting
Clareon TruPlus Study
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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing fanfilcon A in people with Astigmatism, 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 14 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 10 Apr 2018. 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 13 Mar 2018). 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?

Visual Acuity (time frame: baseline, 2 weeks, 1 month). The study lists 5 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 NCT02921412.

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 10 Apr 2018.