Refractive ErrorNCT01582789

Comparative Study of Two Marketed Spherical Soft Contact Lenses

A study testing enfilcon A and senofilcon A in people with Refractive Error, run by CooperVision, Inc. at 2 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 is to obtain objective and subjective clinical data to compare the performance of two soft contact lenses. Read more about this study

Who is it for?: Ages 18 to 38 yearsHealthy volunteers can take part
Conditions the study is for: Refractive Error
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: 61 participants
Where: 2 sitesUnited States
Study dates: 9 Apr 2012to 31 Jul 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

Subjects must satisfy the following conditions prior to inclusion in the study:
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 being evaluated in this trial.

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Require a visual correction in both eyes.
Require a prescription between +8.00D and -12.00D and have less than -0.75D of astigmatism in both eyes.
Achieve visual acuity of 20/25 or better in each eye with a spherical contact lens prescription.
Must be able to wear their lenses at least 10 working days over the next 2-weeks; > 8 hours/day assuming there are no contraindications for doing so.
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); no clinically significant slit lamp findings (e.g. infiltrates or other slit 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

Any of the following will render a subject ineligible for inclusion:
Greater than 0.50D of refractive astigmatism in either eye.
Presbyopic or current monovision contact lens wear.
Cannot be currently wearing of either lenses (Avaira or Oasys)
Presence of clinically significant (grade 2-4) anterior segment abnormalities; inflammations 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.

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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 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
To be eligible to enter the study, subjects must have ALL of the inclusion criteria and NONE of the exclusion criteria present.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Advanced Eyecare
Pismo Beach, California, 93449
Eric M. White, OD, Inc.
San Diego, California, 92123

Other trials in United States

About this study

Official title: Clinical Evaluation of CooperVision's Avaira Spherical Daily Wear Soft Contact Lens Versus Vistakon's Oasys Spherical Daily Wear Soft Contact Lens

The purpose of this study is to obtain objective and subjective clinical data to compare the performance of two soft contact lenses.

Read the detailed description

The study will evaluate the daily wear performance of the Avaira (enfilcon A) spherical lens during two weeks of wear compared to Vistakon's Oasys (senofilcon A) spherical lens.

Conditions: Refractive Error
Being tested: enfilcon A, senofilcon 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
enfilcon A daily wear soft contact lens
senofilcon ADevice
senofilcon A daily wear soft contact lens

Study groups in NCT01582789
Study group	Role	What they receive
enfilcon A/senofilcon A	Active comparator	Subjects were randomized to wear enfilcon A then Senofilcon A for two weeks. Receives: Device: enfilcon A; Device: senofilcon A
senofilcon A/enfilcon A	Active comparator	Subjects were randomized to wear senofilcon A then enfilcon A for two weeks 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 - First Intervention
Comfort - on insertion and overall assessed at baseline for first intervention on a scale 0-10. 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt,
Measured: Baseline
Comfort - Second Intervention
Comfort - on insertion and overall assessed at baseline for first intervention on a scale 0-10. 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt,
Measured: Baseline
Comfort - First Intervention
Participant response of comfort for first intervention of study lenses assessed at 2 weeks. Comfort at insertion, comfort at end of day, comfort at 2 weeks, and overall comfort were rated on subjective response scale. (Scale 0-10, 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt).
Measured: 2 Weeks
Comfort - Second Intervention
Participant response of comfort for first intervention of study lenses assessed at 2 weeks. Comfort at insertion, comfort at end of day, comfort at 2 weeks, and overall comfort were rated on subjective response scale. (Scale 0-10, 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt).
Measured: 2 Weeks
Comfortable Wearing Time - First Intervention
Comfortable Wearing Time. (Participant response in number of hours) Obtained at 2 weeks wear for first intervention at week two visit.
Measured: 2 Weeks
Comfortable Wearing Time - Second Intervention
Comfortable Wearing Time. (Participant response in number of hours) Obtained at 2 weeks wear for second intervention at week two visit.
Measured: 2 Weeks

Timeline

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

9 Apr 201231 Jul 2012

First posted23 Apr 2012 (estimated)
Study start9 Apr 2012
Primary completionMay 2012
Study completion31 Jul 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 Refractive ErrorStudies 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: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01582789
Sponsor's protocol ID: EX-MKTG-37
Status last verified: Oct 2020
First submitted: 12 Apr 2012
Last updated: 27 Oct 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

RecruitingPhase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
Myopia
RecruitingPhase 4
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
Astigmatism
Not yet recruiting
Evaluation of the Agreement Between Automated Program-Operated Phoropter Subjective Refraction and Optometrist-Performed Subjective Refraction
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Not yet recruiting
Consistency of an Automated Subjective Refraction Program Between Personnel With Diverse Professional Backgrounds and Senior Optometrists
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Recruiting
Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter
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All Refractive Error trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of CooperVision's Avaira Spherical Daily Wear Soft Contact Lens Versus Vistakon's Oasys Spherical Daily Wear Soft Contact Lens
ClinicalTrials.gov ID: NCT01582789
Acronym / sponsor ID: EX-MKTG-37
Conditions: Refractive Error
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 9 Apr 2012
Primary completion: May 2012 (actual)
Study completion: 31 Jul 2012 (actual)
First posted: 23 Apr 2012 (estimated)
Results: Posted 4 May 2016

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 is to obtain objective and subjective clinical data to compare the performance of two soft contact lenses.

Detailed description

The study will evaluate the daily wear performance of the Avaira (enfilcon A) spherical lens during two weeks of wear compared to Vistakon's Oasys (senofilcon A) spherical lens.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
enfilcon A/senofilcon A	Active comparator	Device: enfilcon A, Device: senofilcon ASubjects were randomized to wear enfilcon A then Senofilcon A for two weeks.
senofilcon A/enfilcon A	Active comparator	Device: enfilcon A, Device: senofilcon ASubjects were randomized to wear senofilcon A then enfilcon A for two weeks

Who may qualify

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

Key inclusion criteria (11 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 being evaluated in this trial.

Key exclusion criteria (11 listed)

Greater than 0.50D of refractive astigmatism in either eye.
Presbyopic or current monovision contact lens wear.
Cannot be currently wearing of either lenses (Avaira or Oasys)
Presence of clinically significant (grade 2-4) anterior segment abnormalities; inflammations 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 Aenfilcon A daily wear soft contact lens	Device	enfilcon A/senofilcon A, senofilcon A/enfilcon A
senofilcon Asenofilcon A daily wear soft contact lens	Device	enfilcon A/senofilcon A, senofilcon A/enfilcon A

Primary outcome

Comfort - First Intervention
Time frame: Baseline
Comfort - on insertion and overall assessed at baseline for first intervention on a scale 0-10. 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt,
Comfort - Second Intervention
Time frame: Baseline
Comfort - on insertion and overall assessed at baseline for first intervention on a scale 0-10. 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt,
Comfort - First Intervention
Time frame: 2 Weeks
Participant response of comfort for first intervention of study lenses assessed at 2 weeks. Comfort at insertion, comfort at end of day, comfort at 2 weeks, and overall comfort were rated on subjective response scale. (Scale 0-10, 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt).
Comfort - Second Intervention
Time frame: 2 Weeks
Participant response of comfort for first intervention of study lenses assessed at 2 weeks. Comfort at insertion, comfort at end of day, comfort at 2 weeks, and overall comfort were rated on subjective response scale. (Scale 0-10, 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt).
Comfortable Wearing Time - First Intervention
Time frame: 2 Weeks
Comfortable Wearing Time. (Participant response in number of hours) Obtained at 2 weeks wear for first intervention at week two visit.
Comfortable Wearing Time - Second Intervention
Time frame: 2 Weeks
Comfortable Wearing Time. (Participant response in number of hours) Obtained at 2 weeks wear for second intervention at week two visit.

Results and safety

Results posted to the registry on 4 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
Enfilcon A, Then Senofilcon A	34	34
Senofilcon A, Then Enfilcon A	27	27

Primary outcome: Comfort - First Intervention

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

Measure	Enfilcon A n = 34	Senofilcon A n = 27
Insertion	9.3 (1.1)	9.3 (1.1)
Overall	9.4 (0.9)	9.3 (0.9)

Population analysed: one drop out at first 2 week follow up

Primary outcome: Comfort - Second Intervention

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

Measure	Enfilcon A n = 27	Senofilcon A n = 33
Insertion	9.1 (1.1)	9.1 (1.3)
Overall	9.1 (1.0)	9.1 (0.9)

Population analysed: one drop out at first 2 week follow up

Primary outcome: Comfort - First Intervention

Time frame: 2 Weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Enfilcon A n = 34	Senofilcon A n = 27
Insertion	8.5 (1.8)	8.3 (2.0)
End of day	7.2 (2.1)	7.7 (1.7)
2 weeks wear	7.7 (2.0)	7.7 (2.1)
Overall	7.9 (1.7)	8.2 (1.8)

Population analysed: one drop out at first 2 week follow up

Primary outcome: Comfort - Second Intervention

Time frame: 2 Weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Enfilcon A n = 27	Senofilcon A n = 33
Insertion	8.5 (1.1)	8.4 (1.6)
End of day	6.3 (2.2)	7.1 (2.3)
2 weeks wear	7.4 (1.8)	7.3 (2.4)
Overall	7.2 (1.8)	7.6 (2.4)

Population analysed: 1 subject withdrew from study.

Adverse events

Time frame: From dispense up to 2 weeks for each intervention. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enfilcon A/Senofilcon A	0 of 34 (0%)	0 of 34 (0%)	Not reported
Senofilcon A/Enfilcon A	0 of 27 (0%)	0 of 27 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Refractive Error

RecruitingPhase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
Myopia
RecruitingPhase 4
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
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Not yet recruiting
Evaluation of the Agreement Between Automated Program-Operated Phoropter Subjective Refraction and Optometrist-Performed Subjective Refraction
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Not yet recruiting
Consistency of an Automated Subjective Refraction Program Between Personnel With Diverse Professional Backgrounds and Senior Optometrists
Refractive Errors
Recruiting
Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter
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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.

Don Siegel, OD study director

CooperVision, Inc.

2 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 Refractive Error, run by CooperVision, Inc. at 2 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 11 inclusion and 11 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 27 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 2 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 4 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?

Comfort - First Intervention (time frame: Baseline). 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?

On the ClinicalTrials.gov record for NCT01582789.

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 27 Oct 2020.