CClinicalTrials.gg
Sign In
CompletedNCT03306641Updated Sep 22, 2020Results posted

A One-Week Crossover Dispensing Evaluation of New Daily Wear Soft Contact Lenses

An interventional study of Test Contact Lens and Nelfilcon A in Myopia, sponsored by CooperVision International Limited (CVIL). Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2020-09-22.

Sponsored by CooperVision International Limited (CVIL) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period 1 week 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 1 week compared to nelfilcon A (control). The primary outcomes of interest is lens fit acceptance.

02

Conditions studied

  • Myopia

Browse trials for

03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Is at least 18 years of age and has full legal capacity to volunteer.
  • Is no greater than 55 years of age.
  • Has read and understood the information consent letter.
  • Is willing and able to follow instructions and maintain the appointment schedule.
  • Is an adapted soft contact lens wearer having worn lenses for a minimum of 4 weeks prior to the study.
  • 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.
  • Wears CLs in both eyes (monvision acceptable, but not monofit)
  • Has clear corneas and no active ocular disease.
  • Has not worn lenses for at least 12 hours before the examination.
  • Is willing to wear the study contact lenses for a minimum 8 hours per day/6 days per week

Exclusion criteria

Exclusion Criteria:

  • Has never worn contact lenses before.
  • Has any systemic disease affecting ocular health.
  • Is using any systemic or topical medications that will affect ocular health.
  • Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
  • Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
  • Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
  • Is aphakic.
  • Has strabismus/amblyopia.
  • Has undergone corneal refractive surgery.
  • Is pregnant, lactating or planning a pregnancy.
  • Is participating in any concurrent clinical or research study.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
45 participants (actual)

Study arms

  • Active comparator
    Test Contact Lens

    Per randomized schedule, subject will wear a pair of the test lens or control lens for one week and then cross-over with the control pair for 1 week.

    Device: Test Contact Lens · Device: Nelfilcon A

  • Active comparator
    nelfilcon A lens (control)

    Per randomized schedule, subject will wear a pair of the control lens for one week and then cross-over with the test pair for 1 week.

    Device: Test Contact Lens · Device: Nelfilcon A

Interventions

  • DeviceTest Contact Lens

    Daily disposable contact lens

  • DeviceNelfilcon A

    Focus Dailies All Day Comfort contact lens (nelfilcon A)

05

What researchers measure

Primary outcomes

  1. Lens Fit Acceptance

    Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)

    Time frame: Baseline

  2. Lens Fit Acceptance

    Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)

    Time frame: 1-Week

06

Results

Posted Sep 22, 2020

Participant flow

First Intervention
Participant flow — First Intervention
MilestoneTest Contact Lens Then Nelfilcon A Lens (Control)Nelfilcon A Lens (Control) Then Test Contact Lens
Started2322
Completed2322
Not completed00
Second Intervention
Participant flow — Second Intervention
MilestoneTest Contact Lens Then Nelfilcon A Lens (Control)Nelfilcon A Lens (Control) Then Test Contact Lens
Started2322
Completed2322
Not completed00

Outcome measures

PrimaryLens Fit Acceptance

Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)

Time frame:
Baseline
Reported as:
Mean · units on a scale
Lens Fit Acceptance
units on a scaleTest Contact LensNelfilcon A Lens (Control)
Lens Fit Acceptance2.6 ± 0.63.1 ± 0.3
PrimaryLens Fit Acceptance

Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)

Time frame:
1-Week
Reported as:
Mean · units on a scale
Lens Fit Acceptance
units on a scaleTest Contact LensNelfilcon A Lens (Control)
Lens Fit Acceptance2.6 ± 0.63.0 ± 0.4

Adverse events

Collected over From dispense up to 1-week on each pair of lenses, a total of two weeks.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Test Contact Lens0/45 (0%)0/45 (0%)0/45 (0%)
Nelfilcon A Lens (Control)0/45 (0%)0/45 (0%)0/45 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Overall Study
<=18 years0
Between 18 and 65 years45
>=65 years0
Age, Continuous
Age, Continuous(years)Overall Study
Mean26 ± 8
Sex: Female, Male
Sex: Female, Male(Participants)Overall Study
Female32
Male13
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Overall Study
Region of Enrollment
Region of Enrollment(participants)Overall Study
United States45
07

Study locations

1 site
  • Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
    Bloomington, Indiana 47405, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jul 14, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03306641
Lead sponsor
CooperVision International Limited (CVIL)
Responsible party
Sponsor
First posted
Oct 11, 2017
Start date
Jul 28, 2017
Primary completion
Aug 31, 2017
Completion
Aug 31, 2017
Results posted
Sep 22, 2020
Last update
Sep 22, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Myopia→

Other studies from this sponsor

CooperVision International Limited (CVIL)

Start the discussion