MyopiaNCT01494545

Performance Evaluation of DAILIES® TOTAL1™ in First Time Contact Lens Wearers

A study testing Delefilcon A contact lens in people with Myopia, run by Alcon Research.

Completed

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

Trial summary

The purpose of this study was to evaluate the performance of DAILIES® TOTAL1™ in first time contact lens wearers. Read more about this study

Who is it for?: Ages 18 to 44 years
Conditions the study is for: Myopia
What is being tested?: Delefilcon A contact lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: No sites listed yet
Study dates: Dec 2011to Apr 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 44 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Sign Informed Consent.
No previous contact lens experience or attempt to try contact lenses (neophyte).
Willing to wear study lenses for at least 8 hours a day for at least 5 days a week.
Use spectacle lenses for vision correction.
Other protocol-defined inclusion criteria may apply.

Who cannot join

45 years or older.
Prior wear experience with rigid or soft contact lenses.
Systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study.
History of ocular surgery/trauma within the last six months.
Pregnant or nursing women.
Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
Other protocol-defined exclusion criteria may apply.

About this study

The purpose of this study was to evaluate the performance of DAILIES® TOTAL1™ in first time contact lens wearers.

Conditions: Myopia
Being tested: Delefilcon A contact lens
Keywords: DAILIES TOTAL1, Alcon, contact lens
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
Also called DAILIES® TOTAL1™
Silicone hydrogel contact lens CE-marked for single use, daily disposable wear

Study groups in NCT01494545
Study group	Role	What they receive
Delefilcon A	Experimental	Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day. Receives: Device: Delefilcon A contact lens

What is being measured

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

Initial Comfort
Initial comfort was rated by the participant and recorded on a questionnaire at time of lens dispense. Initial comfort was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Measured: Day 1
Comfort at Insertion by Visit
Comfort at insertion was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort at insertion was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Measured: Day 7, Day 14
Comfort During the Day by Visit
Comfort during the day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort during the day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Measured: Day 7, Day 14
Comfort at End of Day by Visit
Comfort at end of day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort at end of day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Measured: Day 7, Day 14
Overall Comfort by Visit
Overall comfort was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Overall comfort was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Measured: Day 7, Day 14
Initial Quality of Vision
Initial quality of vision was rated by the participant and recorded on a questionnaire at time of lens dispense. Initial quality of vision was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Measured: Day 1
Quality of Vision at Insertion by Visit
Quality of vision at insertion was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision at insertion was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Measured: Day 7, Day 14
Quality of Vision During the Day by Visit
Quality of vision during the day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision during the day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Measured: Day 7, Day 14
Quality of Vision at End of Day by Visit
Quality of vision at end of day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision at end of day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Measured: Day 7, Day 14
Overall Quality of Vision by Visit
Overall quality of vision was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Overall quality of vision was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Measured: Day 7, Day 14
Average Comfortable Daily Wear Time by Visit
Average comfortable daily wear time was reported by the participant as a single, retrospective evaluation of the previous week of wear.
Measured: Day 7, Day 14
Likert Statement: These Contact Lenses Were so Comfortable That I Don't Feel Anything.
The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
Measured: Day 14
Likert Statement: These Contact Lenses Were so Comfortable That I Barely Felt Anything.
The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
Measured: Day 14
Likert Statement: These Contact Lenses Felt so Comfortable That I Forgot I Was Wearing Them.
The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
Measured: Day 14
Likert Statement: These Contact Lenses Are Perfect for When I Choose Not to Wear my Eye Glasses.
The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
Measured: Day 14
Likert Statement: I Liked These Contact Lenses so Much That I Will Recommend Them to my Friends.
The participant indicated agreement/disagreement with the statement by using a 4-point scale: 22=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
Measured: Day 14
Likert Statement: Overall, my Vision is Better With These Contact Lenses Compared to my Eye Glasses.
The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
Measured: Day 14
Likert Statement: At the End of the Day my Vision is Better With These Contacts Lenses Compared to my Eye Glasses.
The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=strongly agree; 1=agree; -1=disagree; -2=strongly disagree. A single assessment was made for both eyes.
Measured: Day 14
Likert Statement: My Peripheral Vision is Better With These Contact Lenses Than With my Eye Glasses.
The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
Measured: Day 14
Likert Statement: Compared to my Eye Glasses, my Vision With These Contact Lenses is:
The participant indicated overall satisfaction/dissatisfaction with the contact lenses using a 5-point scale: 2=Much Better; 1=A Little Better; 0=Same; -1=A Little Worse; -2=Much Worse. A single assessment was made for both eyes.
Measured: Day 14
Likert Statement: I am Interested in Purchasing These Contact Lenses.
The participant indicated purchase intent using a 4-point scale: 2=Very Interested; 1=Interested; -1=Not Interested; -2=Very Disinterested. A single assessment was made for both eyes.
Measured: Day 14

Secondary outcomes (7)

Lens Surface Characteristics: Dry Areas/Non-wetting
The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together).
Measured: Day 1
Lens Surface Characteristics: Dry Areas/Non-Wetting
The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together).
Measured: Day 7
Lens Surface Characteristics: Dry Areas/Non-Wetting
The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together).
Measured: Day 14
Duration of Overall Training Time
The investigator recorded the time it took for the patient to insert both lenses and remove both lenses, not including instructions.
Measured: Day 1
Investigator's Satisfaction With Lens Fit by Visit
The investigator considered the factors that relate to a well-fitted contact lens, including good centration, adequate movement, and complete corneal coverage, and rated his/her satisfaction with the contact lens fit on 10-point scale, with 1 being not at all satisfied and 10 being very satisfied.
Measured: Day 1, Day 7, Day 14
Investigator's Overall Impression of Surface Wettability by Visit
The investigator rated his/her overall impression of the surface wettability of the contact lens on a 10-point scale (1=poor to 10=excellent).
Measured: Day 1, Day 7, Day 14
Investigator's Rating of Ease of Fit
The investigator indicated agreement/disagreement with the statement, "The study lenses were easy to fit for this subject," by using a 4-point scale: 1=Strongly Agree; 2=Agree; 3=Disagree; 4=Strongly Disagree.
Measured: Day 14

Timeline

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

Dec 2011Apr 2012

First posted19 Dec 2011 (estimated)
Study startDec 2011
Primary completionApr 2012
Study completionApr 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 MyopiaStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01494545
Sponsor's protocol ID: P-347-C-016
Status last verified: Jul 2013
First submitted: 15 Dec 2011
Last updated: 19 Jul 2013
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?

Official record

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 19 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Performance Evaluation of DAILIES® TOTAL1™ in First Time Contact Lens Wearers
ClinicalTrials.gov ID: NCT01494545
Acronym / sponsor ID: P-347-C-016
Conditions: Myopia
Keywords: DAILIES TOTAL1, Alcon, contact lens
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Dec 2011
Primary completion: Apr 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 19 Dec 2011 (estimated)
Results: Posted 25 Jun 2013

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 evaluate the performance of DAILIES® TOTAL1™ in first time contact lens wearers.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Delefilcon A	Experimental	Device: Delefilcon A contact lensDelefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.

Who may qualify

Ages: 18 to 44 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Sign Informed Consent.
No previous contact lens experience or attempt to try contact lenses (neophyte).
Willing to wear study lenses for at least 8 hours a day for at least 5 days a week.
Use spectacle lenses for vision correction.
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (7 listed)

45 years or older.
Prior wear experience with rigid or soft contact lenses.
Systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study.
History of ocular surgery/trauma within the last six months.
Pregnant or nursing women.

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 lensAlso: DAILIES® TOTAL1™Silicone hydrogel contact lens CE-marked for single use, daily disposable wear	Device	Delefilcon A

Primary outcome

Initial Comfort
Time frame: Day 1
Initial comfort was rated by the participant and recorded on a questionnaire at time of lens dispense. Initial comfort was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Comfort at Insertion by Visit
Time frame: Day 7, Day 14
Comfort at insertion was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort at insertion was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Comfort During the Day by Visit
Time frame: Day 7, Day 14
Comfort during the day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort during the day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Comfort at End of Day by Visit
Time frame: Day 7, Day 14
Comfort at end of day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort at end of day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Overall Comfort by Visit
Time frame: Day 7, Day 14
Overall comfort was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Overall comfort was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Initial Quality of Vision
Time frame: Day 1
Initial quality of vision was rated by the participant and recorded on a questionnaire at time of lens dispense. Initial quality of vision was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Quality of Vision at Insertion by Visit
Time frame: Day 7, Day 14
Quality of vision at insertion was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision at insertion was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Quality of Vision During the Day by Visit
Time frame: Day 7, Day 14
Quality of vision during the day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision during the day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Quality of Vision at End of Day by Visit
Time frame: Day 7, Day 14
Quality of vision at end of day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision at end of day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Overall Quality of Vision by Visit
Time frame: Day 7, Day 14
Overall quality of vision was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Overall quality of vision was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Average Comfortable Daily Wear Time by Visit
Time frame: Day 7, Day 14
Average comfortable daily wear time was reported by the participant as a single, retrospective evaluation of the previous week of wear.
Likert Statement: These Contact Lenses Were so Comfortable That I Don't Feel Anything.
Time frame: Day 14
The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
Likert Statement: These Contact Lenses Were so Comfortable That I Barely Felt Anything.
Time frame: Day 14
The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
Likert Statement: These Contact Lenses Felt so Comfortable That I Forgot I Was Wearing Them.
Time frame: Day 14
The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
Likert Statement: These Contact Lenses Are Perfect for When I Choose Not to Wear my Eye Glasses.
Time frame: Day 14
The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
Likert Statement: I Liked These Contact Lenses so Much That I Will Recommend Them to my Friends.
Time frame: Day 14
The participant indicated agreement/disagreement with the statement by using a 4-point scale: 22=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
Likert Statement: Overall, my Vision is Better With These Contact Lenses Compared to my Eye Glasses.
Time frame: Day 14
The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
Likert Statement: At the End of the Day my Vision is Better With These Contacts Lenses Compared to my Eye Glasses.
Time frame: Day 14
The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=strongly agree; 1=agree; -1=disagree; -2=strongly disagree. A single assessment was made for both eyes.
Likert Statement: My Peripheral Vision is Better With These Contact Lenses Than With my Eye Glasses.
Time frame: Day 14
The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
Likert Statement: Compared to my Eye Glasses, my Vision With These Contact Lenses is:
Time frame: Day 14
The participant indicated overall satisfaction/dissatisfaction with the contact lenses using a 5-point scale: 2=Much Better; 1=A Little Better; 0=Same; -1=A Little Worse; -2=Much Worse. A single assessment was made for both eyes.
Likert Statement: I am Interested in Purchasing These Contact Lenses.
Time frame: Day 14
The participant indicated purchase intent using a 4-point scale: 2=Very Interested; 1=Interested; -1=Not Interested; -2=Very Disinterested. A single assessment was made for both eyes.

7 secondary outcomes

Lens Surface Characteristics: Dry Areas/Non-wetting
Time frame: Day 1
Lens Surface Characteristics: Dry Areas/Non-Wetting
Time frame: Day 7
Lens Surface Characteristics: Dry Areas/Non-Wetting
Time frame: Day 14
Duration of Overall Training Time
Time frame: Day 1
Investigator's Satisfaction With Lens Fit by Visit
Time frame: Day 1, Day 7, Day 14
Investigator's Overall Impression of Surface Wettability by Visit
Time frame: Day 1, Day 7, Day 14
Investigator's Rating of Ease of Fit
Time frame: Day 14

Results and safety

Results posted to the registry on 25 Jun 2013, 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	102	92

Primary outcome: Initial Comfort

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

Measure	Delefilcon A n = 92
Value	8.6 (1.3)

Population analysed: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

Primary outcome: Comfort at Insertion by Visit

Time frame: Day 7, Day 14. Mean (Standard Deviation). Unit: Units on a scale

Measure	Delefilcon A n = 92
Day 7	8.6 (1.3)
Day 14	8.8 (1.2)

Population analysed: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

Primary outcome: Comfort During the Day by Visit

Time frame: Day 7, Day 14. Mean (Standard Deviation). Unit: Units on a scale

Measure	Delefilcon A n = 92
Day 7	8.7 (1.3)
Day 14	8.9 (1.0)

Population analysed: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

Primary outcome: Comfort at End of Day by Visit

Time frame: Day 7, Day 14. Mean (Standard Deviation). Unit: Units on a scale

Measure	Delefilcon A n = 92
Day 7	7.5 (1.8)
Day 14	7.9 (1.5)

Population analysed: This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected for the duration of the study from informed consent signature until last follow-up visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Delefilcon A	0 of 98 (0%)	0 of 98 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2013.
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.

Jami Kern, PhD study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A study testing Delefilcon A contact lens in people with Myopia, run by Alcon Research.

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 5 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 19 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

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 25 Jun 2013). 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?

Initial Comfort (time frame: Day 1). The study lists 21 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 NCT01494545.

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 19 Jul 2013.