CClinicalTrials.gg
Sign In
CompletedNCT02366923Updated Jul 29, 2020Results posted

Dehydration of Stenfilcon A Contact Lenses Versus Delefilcon A Contact Lenses

An interventional study of stenfilcon A and delefilcon A in Myopia, sponsored by CooperVision International Limited (CVIL). Completed at 1 site in Canada. Open to participants aged 17 Years and older. Per ClinicalTrials.gov, last updated 2020-07-29.

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

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
17 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Myopia

Browse trials for

03

In context

Dehydration

204 studies on the registry are indexed under Dehydration; 29 are open to participants now.

This study's enrollment of 28 is below the median of 43 across 147 interventional studies indexed under Dehydration.

Browse Dehydration studies →

Lead sponsor

CooperVision International Limited (CVIL) is the lead sponsor of 138 studies on the registry; 9 are open to participants now.

Of its 72 completed or terminated interventional studies of FDA-regulated products, 67 (93%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Is at least 17 years of age and has full legal capacity to volunteer;
  2. Has read and signed an information consent letter;
  3. Is willing and able to follow instructions and maintain the appointment schedule;
  4. Is a current wearer of soft contact lenses and has worn them (any brand) more than 3 months.
  5. Is able to wear lenses for at least 12 hours a day.

Exclusion criteria

Exclusion Criteria:

  1. Is participating in any concurrent clinical study;
  2. Has any known active* ocular disease and/or infection;
  3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
  5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;

  6. 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    stenfilcon A

    Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).

    Device: stenfilcon A · Device: delefilcon A

  • Active comparator
    delefilcon A

    Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).

    Device: stenfilcon A · Device: delefilcon A

Interventions

  • Devicestenfilcon A

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

  • Devicedelefilcon A

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

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 12 Hours of Wear

  2. 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).

    Time frame: 12 Hours of Wear

  3. 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).

    Time frame: 12 Hours of Wear

  4. 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).

    Time frame: 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)

    Time frame: Up to 12 Hours of Wear

07

Results

Posted Mar 29, 2016

Participant flow

Participant flow — Overall Study
MilestoneOverall Participants
Started28
Completed22
Not completed6
Withdrew: Withdrawal by subject1
Withdrew: Positive slit lamp findings2
Withdrew: High astigmatism3

Outcome measures

PrimaryAbsolute 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).

Time frame:
12 Hours of Wear
Reported as:
Mean · absolute WC change
Absolute Change in Water Content (Mean) of Stenfilcon A and Delefilcon A
absolute WC changeStenfilcon ADelefilcon A
Absolute Change in Water Content (Mean) of Stenfilcon A and Delefilcon A2.82 ± 1.312.91 ± 2.31
SecondarySubjective 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)

Time frame:
Up to 12 Hours of Wear
Reported as:
Mean · units on a scale
Subjective Comfort of Stenfilcon A and Delefilcon A
units on a scaleStenfilcon ADelefilcon A
0 HR92.0 ± 11.593.9 ± 8.4
1 HR90.5 ± 8.492.8 ± 8.6
2 HR90.9 ± 8.893.6 ± 6.2
3 HR89.8 ± 10.992.7 ± 7.0
4 HR89.7 ± 9.391.8 ± 8.0
5 HR89.1 ± 9.590.6 ± 8.4
6 HR87.5 ± 10.491.8 ± 7.8
7 HR86.8 ± 10.489.5 ± 10.0
8 HR84.7 ± 10.587.2 ± 10.7
9 HR83.0 ± 11.685.6 ± 12.6
10 HR80.9 ± 12.083.9 ± 13.4
11 HR78.0 ± 14.881.4 ± 15.2
12 HR75.5 ± 16.281.1 ± 14.7
PrimaryAbsolute 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).

Time frame:
12 Hours of Wear
Reported as:
Median · absolute WC change
Absolute Change in Water Content (Median) of Stenfilcon A and Delefilcon A
absolute WC changeStenfilcon ADelefilcon A
Absolute Change in Water Content (Median) of Stenfilcon A and Delefilcon A2.76 (0 to 6.11)2.35 (0.3 to 8.03)
PrimaryMoisture 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).

Time frame:
12 Hours of Wear
Reported as:
Mean · percentage of dehyrdation
Moisture Retention (Mean) of Stenfilcon A and Delefilcon A
percentage of dehyrdationStenfilcon ADelefilcon A
Moisture Retention (Mean) of Stenfilcon A and Delefilcon A5.22 ± 2.429.21 ± 7.38
PrimaryMoisture 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).

Time frame:
12 Hours of Wear
Reported as:
Median · percentage of dehyrdation
Moisture Retention (Median) of Stenfilcon A and Delefilcon A
percentage of dehyrdationStenfilcon ADelefilcon A
Moisture Retention (Median) of Stenfilcon A and Delefilcon A5.15 (0 to 11.29)7.41 (1.02 to 25.81)

Adverse events

Collected over From dispense up to 12 hours for each study lenses. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Overall Participants—0/22 (0%)0/22 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Overall Participants
Mean27.1 ± 9.9
Age, Continuous
Age, Continuous(years)Overall Participants
Median25 (18 to 63)
Sex: Female, Male
Sex: Female, Male(Participants)Overall Participants
Female16
Male6
08

Study locations

1 site
  • University of Waterloo School of Optometry
    Waterloo, Ontario N2L 3G1, Canada
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02366923
Lead sponsor
CooperVision International Limited (CVIL)
Responsible party
Sponsor
First posted
Feb 19, 2015
Start date
Apr 2015
Primary completion
Apr 2015
Completion
Jun 2015
Results posted
Mar 29, 2016
Last update
Jul 29, 2020

Study contacts

Lydon Jones, PhD FC
principal investigator · Director, Centre for Contact Lens Research
Farah Panjwani, BSc RAQ
principal investigator · Univerisy of Waterloo

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 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

Dehydration→

Other studies from this sponsor

CooperVision International Limited (CVIL)

Start the discussion