MyopiaNCT02094677

Daily Disposable Comparison Study

A study testing filcon II 3, etafilcon A and nelfilcon A in people with Myopia, run by CooperVision, Inc. at 1 site in Canada.

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 objective of the study is to compare the overall subjective preference between two Daily Disposable hydrogel lenses when refitted into a third hydrogel lens. Read more about this study

Who is it for?: Ages 17 to 40 years
Conditions the study is for: Myopia
What is being tested?: filcon II 3, etafilcon A and nelfilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteCanada
Study dates: Mar 2014to Apr 2014
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 17 to 40 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Is at least 17 years of age and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual correction and the assigned study lenses;
Habitually wears either 1 Day Acuvue Moist or Dailies Aqua Comfort Plus contact lenses.
Demonstrates an acceptable fit with the study lenses

Who cannot join

Is participating in any concurrent clinical or research study;
Has any known active* ocular disease and/or infection;
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
Is aphakic;
Has undergone refractive error surgery;

Trial locations and contacts

1 site in 1 country.

Canada1 site

Centre for Contact Lens Research
Waterloo, Ontario, N2L 3G1

Other trials in Canada

About this study

The objective of the study is to compare the overall subjective preference between two Daily Disposable hydrogel lenses when refitted into a third hydrogel lens.

Read the detailed description

This was a two-day, randomized, non-dispensing, double-masked, contralateral study with two parallel groups. Participants were recruited into one of two groups - participants who habitually wore etafilcon A lens and participants who habitually wore nelfilcon A lens.

Conditions: Myopia
Being tested: filcon II 3, etafilcon A, nelfilcon A
Medical subject headings: Myopia

What participants receive

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

filcon II 3Device
Also called Hydrogel Daily Disposable Contact Lens
Participants were randomized to wear filcon II 3 test lens.
etafilcon ADevice
Also called Hydrogel Daily Disposable Contact Lens, 1 Day Acuvue Moist
Participants were randomized to wear etafilcon A control lens.
nelfilcon ADevice
Also called Hydrogel Daily Disposable Contact Lens, Dailies Aqua Comfort Plus
Participants were randomized to wear nelfilcon A control lens.

Study groups in NCT02094677
Study group	Role	What they receive
filcon II 3 and etafilcon A	Active comparator	Participants were randomized to a test and control lens for each group in a contralateral design. Receives: Device: filcon II 3; Device: etafilcon A
filcon II 3 and nelfilcon A	Active comparator	Participants were randomized to a test and control lens for each group in a contralateral design. Receives: Device: filcon II 3; Device: nelfilcon A

What is being measured

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

Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Participant's subjective response for lens preference of filcon II 3 and etafilcon A or filcon II 3 and nelfilcon A at baseline visit, following insertion, after settling 10-15mins (surveyed at baseline visit) rated by questionnaire.
(5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).
Measured: Baseline visit
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Participant's subjective response for lens preference of filcon II 3 and etafilcon A after 3 hours lens wear rated by questionnaire. (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).
Measured: 3 hours
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Participant's subjective response for lens preference of filcon II 3 and etafilcon A after 6 hours lens wear rated by questionnaire (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).
Measured: 6 hours

Secondary outcomes (26)

Lens Comfort - Filcon II 3 and Etafilcon A
Participant's subjective response for lens comfort of filcon II 3 and etafilcon A after settling 10-15mins (surveyed at baseline visit, 3 hours, and 6 hours) rated by questionnaire (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).
Measured: Baseline, 3 hours, 6 hours
Lens Comfort - Filcon II 3 and Nelficon A
Participant's subjective response for lens comfort of filcon II 3 and nelfilcon A after settling 10-15mins (surveyed at baseline visit, 3 hours, and 6 hours) rated by questionnaire (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).
Measured: Baseline, 3 hours, 6 hours
Lens Dryness - Filcon II 3 and Etafilcon A
Participant's subjective response for lens dryness of filcon II 3 and etafilcon A (surveyed at 3 and 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=cannot be worn, extremely dry 100=no dryness experienced).
Measured: 3 hours and 6 hours
Lens Dryness - Filcon II 3 and Nelfilcon A
Participant's subjective response for lens dryness of filcon II 3 and nelfilcon A (surveyed at 3 and 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced).
Measured: 3 hours and 6 hours
Lens Handling - Filcon II 3 and Etafilcon A
Participant's subjective response for lens handling of filcon II 3 and etafilcon A following insertion (surveyed at baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle causes pain, 100=very easy to handle).
Measured: Baseline visit
Lens Handling - Filcon II 3 and Nelfilcon A
Participant's subjective response for lens handling of filcon II 3 and nelfilcon A following insertion (surveyed at baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).
Measured: Baseline visit
Lens Handling (Removal) - Filcon II 3 and Etafilcon A
Participant's subjective response for lens handling of filcon II 3 and etafilcon A following insertion (surveyed 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).
Measured: 6 hours
Lens Handling (Removal) - Filcon II 3 and Nelfilcon A
Participant's subjective response for lens handling of filcon II 3 and nelfilcon A following removal (surveyed 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).
Measured: 6 hours
Lens Wettability - Filcon II 3 and Etafilcon A
The ophthalmologist's objective assessment for lens wettability of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Scale 0-4, 0.25 increments, 0=excellent wettability, 4=severely reduced wettability).
Measured: Baseline and 6 hours
Lens Wettability - Filcon II 3 and Nelfilcon A
The ophthalmologist's objective assessment for lens wettability of filcon II 3 and nelficon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Scale 0-4, 0.25 increments, 0=excellent wettability, 4=severely reduced wettability).
Measured: Baseline and 6 hours
Lens Fit, Centration - Filcon II 3 and Etafilcon A
The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and etafilcon A following insertion (assessed at baseline visit) by biomicroscopy (Optimum or Decentered N T S I).
N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior
Measured: Baseline
Lens Fit, Centration - Filcon II 3 and Etafilcon A
The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and etafilcon A following insertion (assessed at 6 hours) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior
Measured: 6 hours
Lens Fit, Centration - Filcon II 3 and Nelfilcon A
The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and nelfilcon A following insertion (assessed at baseline) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior
Measured: Baseline
Lens Fit, Centration - Filcon II 3 and Nelfilcon A
The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and nelfilcon A following insertion (assessed at 6 hours) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior
Measured: After 6 hours
Lens Fit, Post-Blink Movement - Filcon II 3 and Etafilcon A
The ophthalmologist's objective assessment for lens fit for Post-Blink Movement of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (measured in Primary Gaze and recorded in 0.1mm steps).
Measured: Baseline and 6 hours
Lens Fit, Post-Blink Movement - Filcon II 3 and Nelfilcon A
The ophthalmologist's objective assessment for lens fit for Post-Blink Movement of filcon II 3 and nelfilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (measured in Primary Gaze and recorded in 0.1mm steps).
Measured: Baseline and 6 hours
Lens Fit, Tightness - Filcon II 3 and Etafilcon A
The ophthalmologist's objective assessment for lens fit for tightness of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Percentage of tightness, 5 increments, 0-100, 0=extremely loose, 100=extremely tight).
Measured: Baseline and 6 hours
Lens Fit, Tightness - Filcon II 3 and Nelfilcon A
The ophthalmologist's objective assessment for lens fit for tightness of filcon II 3 and nelfilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Percentage of tightness, 5 increments, 0-100, 0=extremely loose, 100=extremely tight).
Measured: Baseline and 6 hours
Lens Surface Deposition - Filcon II 3 and Etafilcon A
The ophthalmologist's objective assessment for lens surface deposition of filcon II 3 and etafilcon A following insertion (assessed at 6 hour visit) by biomicroscopy (Scale 0-4, 0.25 steps, 0=no deposits, 4=severe deposits).
Measured: 6 hour
Lens Surface Deposition - Filcon II 3 and Nelfilcon A
The ophthalmologist's objective assessment for lens surface deposition of filcon II 3 and nelfilcon A following insertion (assessed at 6 hour visit) by biomicroscopy (Scale 0-4, 0.25 steps, 0=no deposits, 4=severe deposits).
Measured: 6 hour
High Contrast Visual Acuity - Filcon II 3 and Etafilcon A
The ophthalmologist's objective assessment of High Contrast Visual Acuity following filcon II 3 and etafilcon A insertion (assessed at baseline visit and 6 hours) by computerized charts. (Positive logMAR values indicate poorer vision, negative values denote better vision than baseline 20/20 value).
Measured: Baseline and 6 hours
High Contrast Visual Acuity - Filcon II 3 and Nelfilcon A
The ophthalmologist's objective assessment of High Contrast Visual Acuity following filcon II 3 and nelfilcon A insertion (assessed at baseline visit and 6 hours) by computerized charts. (Positive logMAR values indicate poorer vision, negative values denote better vision than baseline 20/20 value)
Measured: Baseline and 6 hours
Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A
The ophthalmologist's objective assessment of corneal staining (extent) assessed at screening (before lens insertion) by biomicroscopy (Grade as a % of each zone).
N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central
Measured: 6 hours
Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A
The ophthalmologist's objective assessment of corneal staining (extent) assessed at 6 hours by biomicroscopy (Grade as a % of each zone).
N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central
Measured: 6 hours
Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Etafilcon A
The ophthalmologist's objective assessment of conjunctival bulbar and limbal hyperemia assessed at screening (before lens insertion) by biomicroscopy (Scale 0-4, 0.5 increments, 0=no redness, 4=redness).
Measured: Baseline and 6 hours
Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Nelfilcon A
The ophthalmologist's objective assessment of conjunctival bulbar and limbal hyperemia assessed at screening (before lens insertion of filcon II 3 and nelfilcon A) by biomicroscopy (Scale 0-4, 0.5 increments, 0=no redness, 4=redness).
Measured: Baseline and 6 hours

Timeline

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

Mar 2014Apr 2014

First posted24 Mar 2014 (estimated)
Study startMar 2014
Primary completionApr 2014
Study completionApr 2014

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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02094677
Sponsor's protocol ID: EX-MKTG-50
Status last verified: Jul 2020
First submitted: 13 Mar 2014
Last updated: 28 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 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Daily Disposable Comparison Study
ClinicalTrials.gov ID: NCT02094677
Acronym / sponsor ID: EX-MKTG-50
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Mar 2014
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 24 Mar 2014 (estimated)
Results: Posted 11 Mar 2016

Clinical summary

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

The objective of the study is to compare the overall subjective preference between two Daily Disposable hydrogel lenses when refitted into a third hydrogel lens.

Detailed description

Study design

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

Arm	Type	Receives
filcon II 3 and etafilcon A	Active comparator	Device: filcon II 3, Device: etafilcon AParticipants were randomized to a test and control lens for each group in a contralateral design.
filcon II 3 and nelfilcon A	Active comparator	Device: filcon II 3, Device: nelfilcon AParticipants were randomized to a test and control lens for each group in a contralateral design.

Who may qualify

Ages: 17 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

Is at least 17 years of age and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual correction and the assigned study lenses;
Habitually wears either 1 Day Acuvue Moist or Dailies Aqua Comfort Plus contact lenses.

Key exclusion criteria (8 listed)

Is participating in any concurrent clinical or research study;
Has any known active* ocular disease and/or infection;
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;

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 II 3Also: Hydrogel Daily Disposable Contact LensParticipants were randomized to wear filcon II 3 test lens.	Device	filcon II 3 and etafilcon A, filcon II 3 and nelfilcon A
etafilcon AAlso: Hydrogel Daily Disposable Contact Lens, 1 Day Acuvue MoistParticipants were randomized to wear etafilcon A control lens.	Device	filcon II 3 and etafilcon A
nelfilcon AAlso: Hydrogel Daily Disposable Contact Lens, Dailies Aqua Comfort PlusParticipants were randomized to wear nelfilcon A control lens.	Device	filcon II 3 and nelfilcon A

Primary outcome

Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Time frame: Baseline visit
Participant's subjective response for lens preference of filcon II 3 and etafilcon A or filcon II 3 and nelfilcon A at baseline visit, following insertion, after settling 10-15mins (surveyed at baseline visit) rated by questionnaire. (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Time frame: 3 hours
Participant's subjective response for lens preference of filcon II 3 and etafilcon A after 3 hours lens wear rated by questionnaire. (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Time frame: 6 hours
Participant's subjective response for lens preference of filcon II 3 and etafilcon A after 6 hours lens wear rated by questionnaire (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).

26 secondary outcomes

Lens Comfort - Filcon II 3 and Etafilcon A
Time frame: Baseline, 3 hours, 6 hours
Lens Comfort - Filcon II 3 and Nelficon A
Time frame: Baseline, 3 hours, 6 hours
Lens Dryness - Filcon II 3 and Etafilcon A
Time frame: 3 hours and 6 hours
Lens Dryness - Filcon II 3 and Nelfilcon A
Time frame: 3 hours and 6 hours
Lens Handling - Filcon II 3 and Etafilcon A
Time frame: Baseline visit
Lens Handling - Filcon II 3 and Nelfilcon A
Time frame: Baseline visit
Lens Handling (Removal) - Filcon II 3 and Etafilcon A
Time frame: 6 hours
Lens Handling (Removal) - Filcon II 3 and Nelfilcon A
Time frame: 6 hours
Lens Wettability - Filcon II 3 and Etafilcon A
Time frame: Baseline and 6 hours
Lens Wettability - Filcon II 3 and Nelfilcon A
Time frame: Baseline and 6 hours
Lens Fit, Centration - Filcon II 3 and Etafilcon A
Time frame: Baseline
Lens Fit, Centration - Filcon II 3 and Etafilcon A
Time frame: 6 hours
Lens Fit, Centration - Filcon II 3 and Nelfilcon A
Time frame: Baseline
Lens Fit, Centration - Filcon II 3 and Nelfilcon A
Time frame: After 6 hours
Lens Fit, Post-Blink Movement - Filcon II 3 and Etafilcon A
Time frame: Baseline and 6 hours
Lens Fit, Post-Blink Movement - Filcon II 3 and Nelfilcon A
Time frame: Baseline and 6 hours
Lens Fit, Tightness - Filcon II 3 and Etafilcon A
Time frame: Baseline and 6 hours
Lens Fit, Tightness - Filcon II 3 and Nelfilcon A
Time frame: Baseline and 6 hours
Lens Surface Deposition - Filcon II 3 and Etafilcon A
Time frame: 6 hour
Lens Surface Deposition - Filcon II 3 and Nelfilcon A
Time frame: 6 hour
High Contrast Visual Acuity - Filcon II 3 and Etafilcon A
Time frame: Baseline and 6 hours
High Contrast Visual Acuity - Filcon II 3 and Nelfilcon A
Time frame: Baseline and 6 hours
Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A
Time frame: 6 hours
Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A
Time frame: 6 hours
Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Etafilcon A
Time frame: Baseline and 6 hours
Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Nelfilcon A
Time frame: Baseline and 6 hours

Results and safety

Results posted to the registry on 11 Mar 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
Filcon II 3 and Etafilcon A	43	40
Filcon II 3 and Nelfilcon A	31	30

Primary outcome: Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A

Time frame: Baseline visit. Number. Unit: participants

Measure	Filcon II 3 and Etafilcon A n = 40	Filcon II 3 and Nelfilcon A n = 30
Strongly prefer filcon II 3	1	3
Slightly prefer filcon II 3	14	8
No preference	8	10
Slightly prefer etafilcon A/nelfilcon A	8	6
Strongly prefer etafilcon A/nelfilcon A	9	3

Primary outcome: Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A

Time frame: 3 hours. Number. Unit: participants

Measure	Filcon II 3 and Etafilcon A n = 40	Filcon II 3 and Nelfilcon A n = 30
Strongly prefer filcon II 3	1	3
Slightly prefer filcon II 3	10	12
No preference	7	5
Slightly prefer etafilcon A/nelfilcon A	13	8
Strongly prefer etafilcon A/nelfilcon A	9	2

Primary outcome: Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A

Time frame: 6 hours. Number. Unit: participants

Measure	Filcon II 3 and Etafilcon A n = 40	Filcon II 3 and Nelfilcon A n = 30
Strongly prefer filcon II 3	2	5
Slightly prefer filcon II 3	9	8
No preference	7	9
Slightly prefer etafilcon A/nelfilcon A	11	5
Strongly prefer etafilcon A/nelfilcon A	11	3

26 secondary outcomes are reported in the full results.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Filcon II 3 and Etafilcon A	0 of 40 (0%)	0 of 40 (0%)	Not reported
Filcon II 3 and Nelfilcon A	0 of 30 (0%)	0 of 30 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Myopia

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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.

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 II 3, etafilcon A and nelfilcon A in people with Myopia, run by CooperVision, Inc. at 1 site in Canada.

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 6 inclusion and 8 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 28 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 Canada. 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 11 Mar 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 Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A (time frame: Baseline visit). The study lists 3 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 NCT02094677.

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 28 Jul 2020.