MyopiaTUNGSTENNCT01371552

Performance Evaluation of a New Daily Disposable Silicone Hydrogel Lens

A study testing delefilcon A contact lens, filcon II 3 contact lenses and narafilcon A contact lenses in people with Myopia, run by CIBA VISION 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

Search all trials

Trial summary

The purpose of this study was to compare a new daily disposable, silicone hydrogel contact lens to marketed daily disposable, silicone hydrogel contact lenses. Read more about this study

Who is it for?: Ages 17 years and older
Conditions the study is for: Myopia
What is being tested?: delefilcon A contact lens, filcon II 3 contact lenses and narafilcon A contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 119 participants
Where: 1 siteCanada
Study dates: May 2011to Aug 2011
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 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

17 years of age; full legal capacity to volunteer.
Ocular examination within the last two years
Correctable to a visual acuity of 20/30 or better (in each eye) with habitual vision correction.
Currently wearing soft contact lenses.
Clear corneas; no active ocular disease.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Currently wearing 1-DAY ACUVUE TruEye or Sauflon Clariti 1-DAY contact lenses.
Monovision.
Any ocular disease.
Never worn contact lenses before.
Corneal refractive surgery.
Uses topical ocular medicine.
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

Other trials in Canada

About this study

Official title: Performance Evaluation of a New Daily Disposable Silicone Hydrogel Lens (TUNGSTEN)

The purpose of this study was to compare a new daily disposable, silicone hydrogel contact lens to marketed daily disposable, silicone hydrogel contact lenses.

Read the detailed description

Part 1 of the study involved bilateral wear of three different types of marketed contact lenses. Each type of lens was worn for three consecutive days of daily disposable wear. Participants had been previously identified as symptomatic lens wearers or asymptomatic lens wearers, based upon their responses to a screening questionnaire. Participants wore each lens type for as long as they were comfortable during the day, but lenses were removed before sleep. After completion of Part 1, participants began Part 2, which included dispensing of the investigational study lens for up to one week of bilateral wear, with a single follow-up visit at the end of that period.

Conditions: Myopia
Being tested: delefilcon A contact lens, filcon II 3 contact lenses, narafilcon A contact lenses
Medical subject headings: Myopia

What participants receive

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

delefilcon A contact lensDevice
Investigational, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1 and one week in Part 2.
filcon II 3 contact lensesDevice
Also called Clariti 1-DAY
Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.
narafilcon A contact lensesDevice
Also called 1-DAY ACUVUE TruEye
Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.

Study groups in NCT01371552
Study group	Role	What they receive
delefilcon A	Experimental	Part 1: Delefilcon A contact lenses, followed by filcon II 3 contact lenses and narafilcon A contact lenses (in randomized order). Each product worn for three consecutive days, with a minimum 1-day washout between each product. At the conclusion of this wear cycle, the delefilcon A contact lenses were worn in Part 2 for one additional week. All products worn bilaterally in a daily wear, daily disposable modality. Receives: Device: delefilcon A contact lens; Device: filcon II 3 contact lenses; Device: narafilcon A contact lenses
filcon II 3	Active comparator	Part 1: Filcon II 3 contact lenses, followed by narafilcon A contact lenses and delefilcon A contact lenses (in randomized order). Each product worn for three consecutive days, with a minimum 1-day washout between each product. At the conclusion of this wear cycle, the delefilcon A contact lenses were worn in Part 2 for one additional week. All products worn bilaterally in a daily wear, daily disposable modality. Receives: Device: delefilcon A contact lens; Device: filcon II 3 contact lenses; Device: narafilcon A contact lenses
narafilcon A	Active comparator	Part 1: Narafilcon A contact lenses, followed by filcon II 3 contact lenses and delefilcon A contact lenses (in randomized order). Each product worn for three consecutive days, with a minimum 1-day washout between each product. At the conclusion of this wear cycle, the delefilcon A contact lenses were worn in Part 2 for one additional week. All products worn bilaterally in a daily wear, daily disposable modality. Receives: Device: delefilcon A contact lens; Device: filcon II 3 contact lenses; Device: narafilcon A contact lenses

What is being measured

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

Mean Value of Comfort During the Day
The participant recorded a number from 0 to 100 in response to the question, "How would you rate the comfort of your lenses over the last hour?" in which 0 = very poor and 100 = excellent. Comfort was assessed at 4 hours, 8 hours, and 12 hours, and the responses were averaged.
Measured: Part 1: Day 2 at 4 hours, 8 hours, and 12 hours
Mean Overall Comfort Given at End of Wear
The participant recorded a number from 0 to 100 in response to the question, "How would you rate the overall comfort of these lenses?" in which 0 = very poor and 100 = excellent. The end of wear questionnaire was completed at time of lens removal for that day.
Measured: Part 1: Day 3
Mean Overall Quality of Vision at End of Wear
The participant recorded a number from 0 to 100 in response to the question, "How would you rate the overall quality of vision while wearing these lenses?" in which 0 = very poor and 100 = excellent. The end of wear questionnaire was completed at time of lens removal for that day.
Measured: Part 1: Day 3
Mean Overall Ease of Handling at End of Wear
The participant recorded a number from 0 to 100 in response to the question, "How would you rate the overall ease of handling these lenses?" in which 0 = very difficult and 100 = very easy. The end of wear questionnaire was completed at time of lens removal for that day.
Measured: Part 1: Day 3
Percentage of Participants Reporting That Their Eyes Rarely or Never Felt Dry at End of Wear
The participant circled a number from 0 to 4 in response to the question, "Over the entire day while wearing these contact lenses, how often did your eyes feel dry?" in which 0 = never, 1 = rarely, 2 = sometimes, 3 = frequently, 4 = constantly. The end of wear questionnaire was completed at time of lens removal for that day.
Measured: Part 1: Day 2
Percentage of Participants Preferring Study Lens Either Strongly or Slightly (of Those With a Preference) vs. Their Habitual Lenses at End of Wear
The participant circled a number from 1 to 5 in response to the question, "Overall, which lens do you prefer - the lens you wore today or your regular lenses?" in which 1 = strongly prefer my regular lenses, 2 = prefer my regular lenses, 3 = no preference, 4 = prefer test lens, 5 = strongly prefer test lens. The end of wear questionnaire was completed at time of lens removal for that day.
Measured: Part 1: Day 3
Lens Wettability
Lens wettability was assessed by the investigator during slit-lamp examination and graded on a 0-4 scale in 0.25 steps, where 0 = excellent and 4 = severely reduced.
Measured: Part 1: Day 1 at Dispense, Day 1 at 8 hours, Day 3 at 8 hours
Percentage of Participants Responding "Yes"
The participant responded to 11 subjective, performance-related statements on a questionnaire by circling 1 = yes, 2 = no, or 3 = don't know.
Measured: Part 2: Day 7

Timeline

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

May 2011Aug 2011

First posted13 Jun 2011 (estimated)
Study startMay 2011
Primary completionAug 2011
Study completionAug 2011

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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01371552
Sponsor's protocol ID: P-371-C-100 v2
Other IDs: P/319/08/C
Acronym: TUNGSTEN
Status last verified: Oct 2012
First submitted: 9 Jun 2011
Last updated: 31 Oct 2012
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

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Performance Evaluation of a New Daily Disposable Silicone Hydrogel Lens (TUNGSTEN)
ClinicalTrials.gov ID: NCT01371552
Acronym / sponsor ID: TUNGSTEN / P-371-C-100 v2
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 119 participants (actual)
Lead sponsor: CIBA VISIONIndustry (pharma, biotech, devices)
Study start: May 2011
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 13 Jun 2011 (estimated)
Results: Posted 31 Oct 2012

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 compare a new daily disposable, silicone hydrogel contact lens to marketed daily disposable, silicone hydrogel contact lenses.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
delefilcon A	Experimental	Device: delefilcon A contact lens, Device: filcon II 3 contact lenses, Device: narafilcon A contact lensesPart 1: Delefilcon A contact lenses, followed by filcon II 3 contact lenses and narafilcon A contact lenses (in randomized order). Each product worn for three consecutive days, with a minimum 1-day washout between each product. At the conclusion of this wear cycle, the delefilcon A contact lenses were worn in Part 2 for one additional week. All products worn bilaterally in a daily wear, daily disposable modality.
filcon II 3	Active comparator	Device: delefilcon A contact lens, Device: filcon II 3 contact lenses, Device: narafilcon A contact lensesPart 1: Filcon II 3 contact lenses, followed by narafilcon A contact lenses and delefilcon A contact lenses (in randomized order). Each product worn for three consecutive days, with a minimum 1-day washout between each product. At the conclusion of this wear cycle, the delefilcon A contact lenses were worn in Part 2 for one additional week. All products worn bilaterally in a daily wear, daily disposable modality.
narafilcon A	Active comparator	Device: delefilcon A contact lens, Device: filcon II 3 contact lenses, Device: narafilcon A contact lensesPart 1: Narafilcon A contact lenses, followed by filcon II 3 contact lenses and delefilcon A contact lenses (in randomized order). Each product worn for three consecutive days, with a minimum 1-day washout between each product. At the conclusion of this wear cycle, the delefilcon A contact lenses were worn in Part 2 for one additional week. All products worn bilaterally in a daily wear, daily disposable modality.

Who may qualify

Ages: 17 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

17 years of age; full legal capacity to volunteer.
Ocular examination within the last two years
Correctable to a visual acuity of 20/30 or better (in each eye) with habitual vision correction.
Currently wearing soft contact lenses.
Clear corneas; no active ocular disease.

Key exclusion criteria (7 listed)

Currently wearing 1-DAY ACUVUE TruEye or Sauflon Clariti 1-DAY contact lenses.
Monovision.
Any ocular disease.
Never worn contact lenses before.
Corneal refractive surgery.

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
delefilcon A contact lensInvestigational, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1 and one week in Part 2.	Device	delefilcon A, filcon II 3, narafilcon A
filcon II 3 contact lensesAlso: Clariti 1-DAYCommercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.	Device	delefilcon A, filcon II 3, narafilcon A
narafilcon A contact lensesAlso: 1-DAY ACUVUE TruEyeCommercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.	Device	delefilcon A, filcon II 3, narafilcon A

Primary outcome

Mean Value of Comfort During the Day
Time frame: Part 1: Day 2 at 4 hours, 8 hours, and 12 hours
The participant recorded a number from 0 to 100 in response to the question, "How would you rate the comfort of your lenses over the last hour?" in which 0 = very poor and 100 = excellent. Comfort was assessed at 4 hours, 8 hours, and 12 hours, and the responses were averaged.
Mean Overall Comfort Given at End of Wear
Time frame: Part 1: Day 3
The participant recorded a number from 0 to 100 in response to the question, "How would you rate the overall comfort of these lenses?" in which 0 = very poor and 100 = excellent. The end of wear questionnaire was completed at time of lens removal for that day.
Mean Overall Quality of Vision at End of Wear
Time frame: Part 1: Day 3
The participant recorded a number from 0 to 100 in response to the question, "How would you rate the overall quality of vision while wearing these lenses?" in which 0 = very poor and 100 = excellent. The end of wear questionnaire was completed at time of lens removal for that day.
Mean Overall Ease of Handling at End of Wear
Time frame: Part 1: Day 3
The participant recorded a number from 0 to 100 in response to the question, "How would you rate the overall ease of handling these lenses?" in which 0 = very difficult and 100 = very easy. The end of wear questionnaire was completed at time of lens removal for that day.
Percentage of Participants Reporting That Their Eyes Rarely or Never Felt Dry at End of Wear
Time frame: Part 1: Day 2
The participant circled a number from 0 to 4 in response to the question, "Over the entire day while wearing these contact lenses, how often did your eyes feel dry?" in which 0 = never, 1 = rarely, 2 = sometimes, 3 = frequently, 4 = constantly. The end of wear questionnaire was completed at time of lens removal for that day.
Percentage of Participants Preferring Study Lens Either Strongly or Slightly (of Those With a Preference) vs. Their Habitual Lenses at End of Wear
Time frame: Part 1: Day 3
The participant circled a number from 1 to 5 in response to the question, "Overall, which lens do you prefer - the lens you wore today or your regular lenses?" in which 1 = strongly prefer my regular lenses, 2 = prefer my regular lenses, 3 = no preference, 4 = prefer test lens, 5 = strongly prefer test lens. The end of wear questionnaire was completed at time of lens removal for that day.
Lens Wettability
Time frame: Part 1: Day 1 at Dispense, Day 1 at 8 hours, Day 3 at 8 hours
Lens wettability was assessed by the investigator during slit-lamp examination and graded on a 0-4 scale in 0.25 steps, where 0 = excellent and 4 = severely reduced.
Percentage of Participants Responding "Yes"
Time frame: Part 2: Day 7
The participant responded to 11 subjective, performance-related statements on a questionnaire by circling 1 = yes, 2 = no, or 3 = don't know.

Results and safety

Results posted to the registry on 31 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Delefilcon A / Filcon II 3 / Narafilcon A	19	19
Narafilcon A / Filcon II 3 / Delefilcon A	17	17
Filcon II 3 / Narafilcon A / Delefilcon A	20	19
Delefilcon A / Narafilcon A / Filcon II 3	20	20
Narafilcon A / Delefilcon A / Filcon II 3	15	15
Filcon II 3 / Delefilcon A / Narafilcon A	18	18

Primary outcome: Mean Value of Comfort During the Day

Time frame: Part 1: Day 2 at 4 hours, 8 hours, and 12 hours. Mean (Standard Deviation). Unit: Units on a scale

Measure	Delefilcon A n = 94	Filcon II 3 n = 88	Narafilcon A n = 85
Value	89 (11)	85 (13)	86 (13)

Population analysed: This reporting group includes all participants who completed 12 hours of lens wear on Day 2.

Primary outcome: Mean Overall Comfort Given at End of Wear

Time frame: Part 1: Day 3. Mean (Standard Deviation). Unit: Units on a scale

Measure	Delefilcon A n = 104	Filcon II 3 n = 104	Narafilcon A n = 104
Value	90 (10)	83 (16)	86 (15)

Population analysed: This reporting group includes all participants who completed all three lens wear periods in Part 1.

Primary outcome: Mean Overall Quality of Vision at End of Wear

Time frame: Part 1: Day 3. Mean (Standard Deviation). Unit: Units on a scale

Measure	Delefilcon A n = 104	Filcon II 3 n = 104	Narafilcon A n = 104
Value	91 (10)	87 (12)	88 (13)

Population analysed: This reporting group includes all participants who completed all three lens wear periods in Part 1.

Primary outcome: Mean Overall Ease of Handling at End of Wear

Time frame: Part 1: Day 3. Mean (Standard Deviation). Unit: Units on a scale

Measure	Delefilcon A n = 104	Filcon II 3 n = 104	Narafilcon A n = 104
Value	90 (13)	91 (12)	93 (10)

Population analysed: This reporting group includes all participants who completed all three lens wear periods in Part 1.

Adverse events

Time frame: Adverse events were collected for the duration of the study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Delefilcon A	0 of 117 (0%)	0 of 117 (0%)	Not reported
Filcon II 3	0 of 117 (0%)	12 of 117 (10.3%)	Not reported
Narafilcon A	0 of 117 (0%)	1 of 117 (0.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

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.

Lyndon Jones, PhD FAAO principal investigator

Centre for Contact Lens Research, School of Optometry, University of Waterloo

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

Questions about this trial

What is this clinical trial studying?

A study testing delefilcon A contact lens, filcon II 3 contact lenses and narafilcon A contact lenses in people with Myopia, run by CIBA VISION 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 7 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 31 Oct 2012. 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 31 Oct 2012). 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?

Mean Value of Comfort During the Day (time frame: Part 1: Day 2 at 4 hours, 8 hours, and 12 hours). The study lists 8 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 NCT01371552.

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 31 Oct 2012.