ClinicalTrials.gg
CompletedNCT06098339Updated Aug 28, 2024Results posted

Performance Evaluation of Reusable Contact Lenses When Worn For One Month By Habitual Soft Contact Lens Wearers

An interventional study of Lens A (fanfilcon A) and Lens B (lotrafilcon B) in Myopia and Hyperopia, sponsored by CooperVision, Inc.. Completed at 3 sites in 2 countries. Open to participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2024-08-28.

Sponsored by CooperVision, Inc. (part of CooperCompanies) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
18 Years to 39 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 22 studies in Myopia by CooperVision, Inc. — none open to participants now, 2 under way, none of them phase 3. Myopia · CooperVision, Inc..

Enrollment
7th of 21
53 · median 45
Started
2023
with 5 others
No phase
21 of 22
none open now
Registered
15th of 22
by date

Among the 22 studies in Myopia by CooperVision, Inc., this one is the 7th largest by enrollment of the 21 interventional ones that give a count, is one of 6 that started in 2023, is one of 21 with no phase, and was the 15th registered.

Myopia

1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.

Browse Myopia studies →

Open to participants now

None of the 22 studies in Myopia by CooperVision, Inc. is open now.

Who these studies take

Of the 122 Myopia studies recruiting now, 19 (16%) set no upper age limit and 102 (84%) stop at 75 or younger; 86 take children under 18; 53 take healthy volunteers.

This study: 18 Years to 39 Years · all sexes · no healthy volunteers.

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Download CSVNarrow it in search →With an account: the 22 studies in Myopia by CooperVision, Inc. as a file.
02

Study summary

The purpose of this study was to compare the clinical performance of two different reusable lenses in habitual spherical soft lens wearers.

Read the detailed description

This study was a prospective, bilateral eye, double-masked, randomized, 1 month cross-over, daily-wear design involving two different frequent replacement type lenses. Duration of involvement for each participant was approximately 3 months.

03

Conditions studied

  • Myopia
  • Hyperopia

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04

Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Were at least 18 years of age and no older than 39 years, and had full legal capacity to volunteer;
  2. Had read and signed an information consent letter;
  3. Were willing and able to follow instructions and maintain the appointment schedule;
  4. Self-reported having had a full eye examination in the previous two years;
  5. Had healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator;
  6. Anticipated being able to wear the study lenses for at least 8 hours a day, 6 days a week;
  7. Habitually wore spherical soft contact lenses, for the past 3 months minimum:

    It was preferred that all participants were habitual frequent replacement lens wearers. However, if this was not possible then no more than 5 participants could be habitual daily disposable lens wearers at each site, the rest had to be habitual frequent replacement lens wearers;

    • For the frequent replacement wearers: No more than 3 could be habitual wearers of the Avaira Vitality™/ Serenity™ brand (or their equivalent private label brand name) and no more than 3 could be habitual wearers of AIR OPTIX® plus HydraGlyde® can be enrolled at each site;
  8. Had refractive astigmatism no higher than -0.75DC in each eye;
  9. Could be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere +6.00 to -6.00D, 0.25D steps).

Exclusion criteria

Exclusion Criteria:

  1. Were participating in any concurrent clinical or research study;
  2. Had any known active ocular disease and/or infection that contact lens wear;
  3. Had a systemic or ocular condition that in the opinion of the investigator may have affected a study outcome variable;
  4. Were using any systemic or topical medications that in the opinion of the investigator may have affect contact lens wear or a study outcome variable;
  5. Had known sensitivity to the diagnostic sodium fluorescein used in the study;
  6. Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
  7. Had undergone refractive error surgery or intraocular surgery.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

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

Study arms

  • Experimental
    Lens A, then Lens B

    Participants wore Lens A for one month and then Lens B for one month.

    Device: Lens A (fanfilcon A) · Device: Lens B (lotrafilcon B)

  • Experimental
    Lens B, then Lens A

    Participants wore Lens B one month and then Lens A for one month.

    Device: Lens A (fanfilcon A) · Device: Lens B (lotrafilcon B)

Interventions

  • DeviceLens A (fanfilcon A)

    Daily wear for one month

  • DeviceLens B (lotrafilcon B)

    Daily wear for one month

06

What researchers measure

Primary outcomes

  1. Lens Handling on Removal

    Participants measured subjective lens handling at removal on a 0-100 integer scale, where 0=worst and 100=best. Results for each lens were collected in the at-home diary on Day 27.

    Time frame: Day 27

07

Results

Posted Jul 9, 2024

Participant flow

Period 1: First Intervention 28-32 Days
Participant flow — Period 1: First Intervention 28-32 Days
MilestoneLens A, Then Lens BLens B, Then Lens A
Started2528
Completed2426
Not completed12
Withdrew: Lost to follow-up01
Withdrew: Enrolled outside the study inclusion/exclusion criteria and was discontinued early11
Period 2: Second Intervention 28-32 Days
Participant flow — Period 2: Second Intervention 28-32 Days
MilestoneLens A, Then Lens BLens B, Then Lens A
Started2426
Completed2426
Not completed00

Outcome measures

PrimaryLens Handling on Removal

Participants measured subjective lens handling at removal on a 0-100 integer scale, where 0=worst and 100=best. Results for each lens were collected in the at-home diary on Day 27.

Time frame:
Day 27
Reported as:
Mean · score on a scale
Lens Handling on Removal
score on a scaleLens ALens B
Lens Handling on Removal84 ± 2189 ± 17

Adverse events

Collected over The duration of the clinical trial, approximately 2-3 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lens A0/50 (0%)0/50 (0%)5/50 (10%)
Lens B0/50 (0%)0/50 (0%)4/50 (8%)
Most frequent other events
Most frequent other events
EventLens ALens B
Ocular discomfort,Eye disorders3/500/50
Viral conjunctivitisEye disorders0/501/50
Asymptomatic corneal infiltrate eventEye disorders1/501/50
Lower lid small chalazionEye disorders0/501/50
Nasal upper lid papillomaEye disorders0/501/50
Upper respiratory tract infectionRespiratory, thoracic and mediastinal disorders1/500/50

Baseline characteristics

Age, Continuous
Age, Continuous(years)Total Study Population
Mean28.2 ± 6.0
Sex: Female, Male
Sex: Female, Male(Participants)Total Study Population
Female37
Male16
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Total Study Population
08

Study locations

3 sites
  • Coan Eye Care
    Ocoee, Florida 34761, United States
  • Nittany Eye Associates
    State College, Pennsylvania 16801, United States
  • Insight Eye Care
    Waterloo, Ontario N2L 3S1, Canada
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2023 to primary completion in Apr 2024, 4 months.

Results were first posted in Jul 2024, 3 months after primary completion.

Of 234 industry-sponsored interventional studies with no phase under Myopia, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 24. This study's 4 months is below that.

Counting every sponsor, half of 434 studies reached it within 14 months; a quarter within 3 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2023
First posted
Oct 24, 2023
StartActual
Nov 13, 2023
Primary completionActual
Apr 4, 2024
CompletionActual
Apr 4, 2024
Results first posted
Jul 9, 2024
Last update
Aug 28, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06098339
Lead sponsor
CooperVision, Inc.
Collaborators
Centre for Ocular Research & Education, Canada
Responsible party
Sponsor
First posted
Oct 24, 2023
Start date
Nov 13, 2023
Primary completion
Apr 4, 2024
Completion
Apr 4, 2024
Results posted
Jul 9, 2024
Last update
Aug 28, 2024

Study contacts

Carolyn MacNeil
principal investigator · Insight Eye Care
Abigail Gillogly-Harsch
principal investigator · Nittany Eye Associates
Roxanne Achong-Coan
principal investigator · Coan Eye Care

Oversight

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

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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