MyopiaNCT03235089

A 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses

A study testing Test Lens in people with Myopia, run by CooperVision, Inc. at 1 site in United States.

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 is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia
What is being tested?: Test Lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteUnited States
Study dates: 25 Jul 2017to 3 Aug 2017
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Is at least 18 years of age and has full legal capacity to volunteer
Has read, fully understood and signed the information consent letter
Currently wears or has previously worn soft contact lenses
Has spectacle cylinder ≤1.00D in both eyes.
Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye.
Has clear corneas and no active ocular disease
Is willing and able to follow product usage instructions and maintain the visit schedule.

Who cannot join

Has never worn contact lenses before
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 any known active ocular disease and/or infection
Has a monovision correction
Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses

Show all 9Show fewer

Is aphakic
Has undergone corneal refractive surgery
Is pregnant or lactating, determined by self-report

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
Bloomington, Indiana, 47405

Other trials in United States

About this study

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control).

Read the detailed description

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control). The primary outcomes of interest are lens fit and lens fit preference.

Conditions: Myopia
Being tested: Test Lens, Control Lens
Medical subject headings: Myopia

What participants receive

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

Test LensDevice
Daily disposable contact lens
Control LensDevice
Focus Dailies All Day Comfort contact lens (nelfilcon A)

Study groups in NCT03235089
Study group	Role	What they receive
Test lens	Active comparator	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens). Receives: Device: Test Lens; Device: Control Lens
nelfilcon A lens (control)	Active comparator	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens). Receives: Device: Test Lens; Device: Control Lens

What is being measured

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

Horizontal Lens Centration Assessed in Primary Gaze
Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)
Measured: Baseline
Horizontal Lens Centration Assessed in Primary Gaze
Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)
Measured: 6-hour
Vertical Lens Centration Assessed in Primary Gaze
Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)
Measured: Baseline
Vertical Lens Centration Assessed in Primary Gaze
Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)
Measured: 6-hours
Lens Tightness Assessed by Push-up Test
Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)
Measured: Baseline
Lens Tightness Assessed by Push-up Test
Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)
Measured: 6-hours
Primary Gaze Lag Assessed Observing Lens Movement in Graticule
Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)
Measured: Baseline
Primary Gaze Lag Assessed Observing Lens Movement in Graticule
Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)
Measured: 6 hours
Horizontal Lens Lag Assessed Observing Lens Movement in Graticule
Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)
Measured: Baseline
Horizontal Lens Lag Assessed Observing Lens Movement in Graticule
Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)
Measured: 6 hours
Overall Lens Fit Acceptance
Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
Measured: Baseline
Overall Lens Fit Acceptance
Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
Measured: 6 hours
Up Gaze Lag Assessed Observing Lens Movement in Graticule
Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).
Measured: Baseline
Up Gaze Lag Assessed Observing Lens Movement in Graticule
Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).
Measured: 6 hours
Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink
Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink
Measured: Baseline
Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink
Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink
Measured: 6 hours

Timeline

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

25 Jul 20173 Aug 2017

First posted1 Aug 2017
Study start25 Jul 2017
Primary completion3 Aug 2017
Study completion3 Aug 2017

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: Non-randomised
Intervention model: Parallel groups
Model description: This will be a non-dispensing, double-masked, contralateral study comparing test contact lens against a nelfilcon A control lens. Subjects will be randomized to wear the test lens in one eye and the control lens in the other. It is anticipated that this study will involve up to 2 scheduled visits, at Baseline (BL) and 6 hours.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03235089
Sponsor's protocol ID: CV-17-46
Status last verified: Sep 2020
First submitted: 27 Jul 2017
Last updated: 14 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: 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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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
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Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses
ClinicalTrials.gov ID: NCT03235089
Acronym / sponsor ID: CV-17-46
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 25 Jul 2017 (actual)
Primary completion: 3 Aug 2017 (actual)
Study completion: 3 Aug 2017 (actual)
First posted: 1 Aug 2017 (actual)
Results: Posted 14 Oct 2020

Clinical summary

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

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: This will be a non-dispensing, double-masked, contralateral study comparing test contact lens against a nelfilcon A control lens. Subjects will be randomized to wear the test lens in one eye and the control lens in the other. It is anticipated that this study will involve up to 2 scheduled visits, at Baseline (BL) and 6 hours.

Arm	Type	Receives
Test lens	Active comparator	Device: Test Lens, Device: Control LensEach subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens).
nelfilcon A lens (control)	Active comparator	Device: Test Lens, Device: Control LensEach subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Is at least 18 years of age and has full legal capacity to volunteer
Has read, fully understood and signed the information consent letter
Currently wears or has previously worn soft contact lenses
Has spectacle cylinder ≤1.00D in both eyes.
Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.

Key exclusion criteria (9 listed)

Has never worn contact lenses before
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 any known active ocular disease and/or infection
Has a monovision correction

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
Test LensDaily disposable contact lens	Device	Test lens, nelfilcon A lens (control)
Control LensFocus Dailies All Day Comfort contact lens (nelfilcon A)	Device	Test lens, nelfilcon A lens (control)

Primary outcome

Horizontal Lens Centration Assessed in Primary Gaze
Time frame: Baseline
Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)
Horizontal Lens Centration Assessed in Primary Gaze
Time frame: 6-hour
Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)
Vertical Lens Centration Assessed in Primary Gaze
Time frame: Baseline
Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)
Vertical Lens Centration Assessed in Primary Gaze
Time frame: 6-hours
Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)
Lens Tightness Assessed by Push-up Test
Time frame: Baseline
Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)
Lens Tightness Assessed by Push-up Test
Time frame: 6-hours
Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)
Primary Gaze Lag Assessed Observing Lens Movement in Graticule
Time frame: Baseline
Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)
Primary Gaze Lag Assessed Observing Lens Movement in Graticule
Time frame: 6 hours
Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)
Horizontal Lens Lag Assessed Observing Lens Movement in Graticule
Time frame: Baseline
Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)
Horizontal Lens Lag Assessed Observing Lens Movement in Graticule
Time frame: 6 hours
Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)
Overall Lens Fit Acceptance
Time frame: Baseline
Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
Overall Lens Fit Acceptance
Time frame: 6 hours
Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
Up Gaze Lag Assessed Observing Lens Movement in Graticule
Time frame: Baseline
Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).
Up Gaze Lag Assessed Observing Lens Movement in Graticule
Time frame: 6 hours
Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).
Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink
Time frame: Baseline
Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink
Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink
Time frame: 6 hours
Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink

Results and safety

Results posted to the registry on 14 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test Lens	31	28
Nelfilcon A Lens (Control)	31	28

Primary outcome: Horizontal Lens Centration Assessed in Primary Gaze

Time frame: Baseline. Mean (Standard Deviation). Unit: millimeters

Measure	Test Lens n = 28	Nelfilcon A Lens (Control) n = 28
Value	-0.13 (0.20)	-0.04 (0.21)

Primary outcome: Horizontal Lens Centration Assessed in Primary Gaze

Time frame: 6-hour. Mean (Standard Deviation). Unit: millimeters

Measure	Test Lens n = 28	Nelfilcon A Lens (Control) n = 28
Value	-0.15 (0.20)	-0.06 (0.16)

Primary outcome: Vertical Lens Centration Assessed in Primary Gaze

Time frame: Baseline. Mean (Standard Deviation). Unit: millimeters

Measure	Test Lens n = 28	Nelfilcon A Lens (Control) n = 28
Value	0.17 (0.25)	0.06 (0.20)

Primary outcome: Vertical Lens Centration Assessed in Primary Gaze

Time frame: 6-hours. Mean (Standard Deviation). Unit: millimeters

Measure	Test Lens n = 28	Nelfilcon A Lens (Control) n = 28
Value	0.10 (0.22)	-0.03 (0.25)

Adverse events

Time frame: From dispense up to 6 hours on each type of study lenses. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Lens	0 of 28 (0%)	0 of 28 (0%)	0 of 28
Nelfilcon A Lens ( Control)	0 of 28 (0%)	0 of 28 (0%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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
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Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
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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 Test Lens in people with Myopia, run by CooperVision, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 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 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Oct 2020). 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?

Horizontal Lens Centration Assessed in Primary Gaze (time frame: Baseline). The study lists 16 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 NCT03235089.

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 14 Oct 2020.