AstigmatismNCT02356692

Clinical Comfort Evaluation of Two Marketed Spherical Contact Lenses

A study testing enfilcon A and senofilcon A in people with Astigmatism, 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 purpose of this study was to investigate the overall clinical comfort performance of enfilcon A (test) lens and senofilcon A (control) lens over 15-minutes of lens wear. Read more about this study

Who is it for?: Ages 18 to 38 yearsHealthy volunteers can take part
Conditions the study is for: Astigmatism
What is being tested?: enfilcon A and senofilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 3 sitesUnited States
Study dates: Apr 2012to May 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 to 38 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Based on his/her knowledge, must be in good general health.
Be 18 to 38 years old.
Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation.
Read, indicate understanding of, and sign Written Informed Consent.
Be existing or successfully adapted users of soft contact lenses, but not currently wearing either of the study lenses (Avaira or Oasys) being evaluated in this trial.
Require a visual correction in both eyes.

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Require a prescription between +8.00D and -12.00D and have less than or equal to 0.75D of astigmatism in both eyes.
Achieve visual acuity of 20/25 or better in each eye with a spherical contact lens prescription.
Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
No amblyopia.
No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes).
lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection).
No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology).
No aphakia.

Who cannot join

0.75D or greater of refractive astigmatism in either eye.
Presbyopic or current monovision contact lens wear.
Cannot be currently wearing either lenses (Avaira or Oasys).
Presence of clinically significant (grade 2-4) anterior segment abnormalities; inflammation such as iritis; or any infection of the eye, lids, or associated structures.
Presence of ocular or systemic disease or need of medication which might interfere with contact lens wear.
Slit lamp findings that would contraindicate contact lens wear such as:

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Pathological dry eye or associated findings
Pterygium, pinguecula or corneal scars within the visual axis
Neovascularization > 0.75 mm in from the limbus
Giant papillary conjunctivitis (GPC) worse than Grade 1
Anterior uveitis or iritis (past or present)
Seborrheic eczema, seborrheic conjunctivitis
History of corneal ulcer or fungal infections
Poor personal hygiene
A known history of corneal hypoesthesia (reduced corneal sensitivity)
Contact Lens best corrected Snellen visual acuities (VA) worse than 20/30.
Aphakia, Keratoconus or a highly irregular cornea.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Schaeffer Eye Associates
Birmingham, Alabama, 35216
Beaches Family Eyecare
Jacksonville, Florida, 32256
Todays Eyecare, LLC
Lafayette, Louisiana, 70503

Other trials in United States

About this study

The purpose of this study was to investigate the overall clinical comfort performance of enfilcon A (test) lens and senofilcon A (control) lens over 15-minutes of lens wear.

Read the detailed description

This was a non-dispensing, single-masked, randomized, contralateral study comparing Enfilcon A (test) against Senofilcon A (control). Each subject was randomized to wear the test lens in one eye and the control lens in the other eye.

Conditions: Astigmatism
Being tested: enfilcon A, senofilcon A
Medical subject headings: Astigmatism

What participants receive

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

enfilcon ADevice
Test lens
senofilcon ADevice
Control lens

Study groups in NCT02356692
Study group	Role	What they receive
enfilcon A	Experimental	participants randomized to wear the Enfilcon A (test) lens in one eye and Senofilcon A (control) lens in the other eye. Receives: Device: enfilcon A; Device: senofilcon A
senofilcon A	Active comparator	participants randomized to wear the Enfilcon A (test) lens in one eye and Senofilcon A (control) lens in the other eye. Receives: Device: enfilcon A; Device: senofilcon A

What is being measured

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

Comfort at Insertion
Participant's response for comfort at insertion. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at baseline.
Measured: Baseline
Comfort at Insertion
Participant's response for comfort at 15 minutes. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at 15 minutes.
Measured: 15 minutes
Comfort Preference
Participant's response for comfort preference of enfilcon A (test) lens, senofilcon A(control) lens at insertion.
Measured: Baseline
Comfort Preference
Participant's response for comfort of enfilcon A (test) lens, senofilcon A (control) lens at 15 minutes wear.
Measured: 15 minutes

Timeline

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

Apr 2012May 2012

First posted5 Feb 2015 (estimated)
Study startApr 2012
Primary completionMay 2012
Study completionMay 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 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02356692
Sponsor's protocol ID: EX-MKTG-38-MTF
Status last verified: Oct 2020
First submitted: 30 Apr 2012
Last updated: 23 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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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Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
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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
Aphakia, Astigmatism

All Astigmatism trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Comfort Evaluation of Two Marketed Spherical Contact Lenses
ClinicalTrials.gov ID: NCT02356692
Acronym / sponsor ID: EX-MKTG-38-MTF
Conditions: Astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2012
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 5 Feb 2015 (estimated)
Results: Posted 23 Nov 2020

Clinical summary

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

The purpose of this study was to investigate the overall clinical comfort performance of enfilcon A (test) lens and senofilcon A (control) lens over 15-minutes of lens wear.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
enfilcon A	Experimental	Device: enfilcon A, Device: senofilcon Aparticipants randomized to wear the Enfilcon A (test) lens in one eye and Senofilcon A (control) lens in the other eye.
senofilcon A	Active comparator	Device: enfilcon A, Device: senofilcon Aparticipants randomized to wear the Enfilcon A (test) lens in one eye and Senofilcon A (control) lens in the other eye.

Who may qualify

Ages: 18 to 38 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (14 listed)

Based on his/her knowledge, must be in good general health.
Be 18 to 38 years old.
Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation.
Read, indicate understanding of, and sign Written Informed Consent.
Be existing or successfully adapted users of soft contact lenses, but not currently wearing either of the study lenses (Avaira or Oasys) being evaluated in this trial.

Key exclusion criteria (17 listed)

0.75D or greater of refractive astigmatism in either eye.
Presbyopic or current monovision contact lens wear.
Cannot be currently wearing either lenses (Avaira or Oasys).
Presence of clinically significant (grade 2-4) anterior segment abnormalities; inflammation such as iritis; or any infection of the eye, lids, or associated structures.
Presence of ocular or systemic disease or need of medication which might interfere with contact lens wear.

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 ATest lens	Device	enfilcon A, senofilcon A
senofilcon AControl lens	Device	enfilcon A, senofilcon A

Primary outcome

Comfort at Insertion
Time frame: Baseline
Participant's response for comfort at insertion. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at baseline.
Comfort at Insertion
Time frame: 15 minutes
Participant's response for comfort at 15 minutes. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at 15 minutes.
Comfort Preference
Time frame: Baseline
Participant's response for comfort preference of enfilcon A (test) lens, senofilcon A(control) lens at insertion.
Comfort Preference
Time frame: 15 minutes
Participant's response for comfort of enfilcon A (test) lens, senofilcon A (control) lens at 15 minutes wear.

Results and safety

Results posted to the registry on 23 Nov 2020, 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	60	60
Senofilcon A	60	60

Primary outcome: Comfort at Insertion

Time frame: Baseline. Mean (Standard Deviation). Unit: units on a scale

Measure	Enfilcon A n = 60	Senofilcon A n = 60
Value	8.7 (1.6)	8.5 (1.7)

Primary outcome: Comfort at Insertion

Time frame: 15 minutes. Mean (Standard Deviation). Unit: units on a scale

Measure	Enfilcon A n = 60	Senofilcon A n = 60
Value	8.1 (1.8)	8.7 (1.3)

Primary outcome: Comfort Preference

Time frame: Baseline. Number. Unit: participants

Measure	Overall Study Group n = 59
Prefer Enfilcon A	30
Prefer Senofilcon A	29

Population analysed: n=59, one participant would not choose a preference at the initial insertion as both lenses were the same to them.

Primary outcome: Comfort Preference

Time frame: 15 minutes. Number. Unit: participants

Measure	Overall Study Group n = 60
Preferred Enfilcon A	25
Preferred Senofilcon A	35

Adverse events

Time frame: From dispense up to 15 minutes for both study lenses.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enfilcon A	0 of 60 (0%)	0 of 60 (0%)	0 of 60
Senofilcon A	0 of 60 (0%)	0 of 60 (0%)	0 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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
Astigmatism, Myopia
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism

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.

Donald Siegel, OD study chair

CooperVision, Inc.

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 senofilcon A in people with Astigmatism, 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 14 inclusion and 17 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 23 Nov 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 23 Nov 2020). 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?

Comfort at Insertion (time frame: Baseline). 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 NCT02356692.

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 23 Nov 2020.