MyopiaNCT02366923

Dehydration of Stenfilcon A Contact Lenses Versus Delefilcon A Contact Lenses

A study testing stenfilcon A and delefilcon 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.

Trial summary

The study will explore in vivo lens dehydration rates across a 12hr wear period for the study 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?: stenfilcon A and delefilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteCanada
Study dates: Apr 2015to Jun 2015
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

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 a current wearer of soft contact lenses and has worn them (any brand) more than 3 months.
Is able to wear lenses for at least 12 hours a day.

Who cannot join

Is participating in any concurrent clinical 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;
Has undergone refractive error surgery;
*For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Trial locations and contacts

1 site in 1 country.

Canada1 site

University of Waterloo School of Optometry
Waterloo, Ontario, N2L 3G1

Other trials in Canada

About this study

The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses.

Read the detailed description

The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses. The primary outcome variable for this study is the loss in lens weight over the day, which will indicate the amount of dehydration that has occured.

Conditions: Myopia
Being tested: stenfilcon A, delefilcon A
Medical subject headings: Myopia

What participants receive

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

stenfilcon ADevice
Each subject randomized to wear either the test or control in either the left of right eye.
delefilcon ADevice
Each subject randomized to wear either the test or control in either the left of right eye.

Study groups in NCT02366923
Study group	Role	What they receive
stenfilcon A	Experimental	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). Receives: Device: stenfilcon A; Device: delefilcon A
delefilcon A	Active comparator	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). Receives: Device: stenfilcon A; Device: delefilcon A

What is being measured

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

Absolute Change in Water Content (Mean) of Stenfilcon A and Delefilcon A
Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).
Measured: 12 Hours of Wear
Absolute Change in Water Content (Median) of Stenfilcon A and Delefilcon A
Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).
Measured: 12 Hours of Wear
Moisture Retention (Mean) of Stenfilcon A and Delefilcon A
Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).
Measured: 12 Hours of Wear
Moisture Retention (Median) of Stenfilcon A and Delefilcon A
Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).
Measured: 12 Hours of Wear

Secondary outcomes (1)

Subjective Comfort of Stenfilcon A and Delefilcon A
Subjective ratings for stenfilcon A and delefilcon A assessed at every hour up to 12 hours. (Scale 0-100, 0=very poor 100=excellent)
Measured: Up to 12 Hours of Wear

Timeline

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

Apr 2015Jun 2015

First posted19 Feb 2015 (estimated)
Study startApr 2015
Primary completionApr 2015
Study completionJun 2015

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: Single group
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02366923
Sponsor's protocol ID: EX-MKTG-56
Status last verified: Jul 2020
First submitted: 12 Feb 2015
Last updated: 29 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

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 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dehydration of Stenfilcon A Contact Lenses Versus Delefilcon A Contact Lenses
ClinicalTrials.gov ID: NCT02366923
Acronym / sponsor ID: EX-MKTG-56
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2015
Primary completion: Apr 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 19 Feb 2015 (estimated)
Results: Posted 29 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 study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
stenfilcon A	Experimental	Device: stenfilcon A, Device: delefilcon AEach subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
delefilcon A	Active comparator	Device: stenfilcon A, Device: delefilcon AEach subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).

Who may qualify

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

Key inclusion criteria (5 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 a current wearer of soft contact lenses and has worn them (any brand) more than 3 months.
Is able to wear lenses for at least 12 hours a day.

Key exclusion criteria (7 listed)

Is participating in any concurrent clinical 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
stenfilcon AEach subject randomized to wear either the test or control in either the left of right eye.	Device	delefilcon A, stenfilcon A
delefilcon AEach subject randomized to wear either the test or control in either the left of right eye.	Device	delefilcon A, stenfilcon A

Primary outcome

Absolute Change in Water Content (Mean) of Stenfilcon A and Delefilcon A
Time frame: 12 Hours of Wear
Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).
Absolute Change in Water Content (Median) of Stenfilcon A and Delefilcon A
Time frame: 12 Hours of Wear
Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).
Moisture Retention (Mean) of Stenfilcon A and Delefilcon A
Time frame: 12 Hours of Wear
Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).
Moisture Retention (Median) of Stenfilcon A and Delefilcon A
Time frame: 12 Hours of Wear
Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).

1 secondary outcome

Subjective Comfort of Stenfilcon A and Delefilcon A
Time frame: Up to 12 Hours of Wear

Results and safety

Results posted to the registry on 29 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
Overall Participants	28	22

Primary outcome: Absolute Change in Water Content (Mean) of Stenfilcon A and Delefilcon A

Time frame: 12 Hours of Wear. Mean (Standard Deviation). Unit: absolute WC change

Measure	Stenfilcon A n = 18	Delefilcon A n = 18
Value	2.82 (1.31)	2.91 (2.31)

Population analysed: There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs.

Primary outcome: Absolute Change in Water Content (Median) of Stenfilcon A and Delefilcon A

Time frame: 12 Hours of Wear. Median (Full Range). Unit: absolute WC change

Measure	Stenfilcon A n = 18	Delefilcon A n = 18
Value	2.76 (0 to 6.11)	2.35 (0.3 to 8.03)

Primary outcome: Moisture Retention (Mean) of Stenfilcon A and Delefilcon A

Time frame: 12 Hours of Wear. Mean (Standard Deviation). Unit: percentage of dehyrdation

Measure	Stenfilcon A n = 18	Delefilcon A n = 18
Value	5.22 (2.42)	9.21 (7.38)

Primary outcome: Moisture Retention (Median) of Stenfilcon A and Delefilcon A

Time frame: 12 Hours of Wear. Median (Full Range). Unit: percentage of dehyrdation

Measure	Stenfilcon A n = 18	Delefilcon A n = 18
Value	5.15 (0 to 11.29)	7.41 (1.02 to 25.81)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From dispense up to 12 hours for each study lenses. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Overall Participants	0 of 22 (0%)	0 of 22 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
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.

Lydon Jones, PhD FC principal investigator

Director, Centre for Contact Lens Research

Farah Panjwani, BSc RAQ principal investigator

Univerisy 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 stenfilcon A and delefilcon 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 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 29 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 29 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?

Absolute Change in Water Content (Mean) of Stenfilcon A and Delefilcon A (time frame: 12 Hours of Wear). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02366923.

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 29 Jul 2020.