CClinicalTrials.gg
CompletedNCT05097144Updated Oct 17, 2023Results posted

Performance of Toric Silicone Hydrogel Contact Lenses

An interventional study of Lens A (fanfilcon A) and Lens B (asmofilcon A) in Astigmatism and Myopia, sponsored by CooperVision, Inc.. Completed at 1 site in Mexico. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-10-17.

Sponsored by CooperVision, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

The purpose of this study was to evaluate the clinical performance and subjective lens handling (insertion and removal) of two toric silicone hydrogel contact lenses after one month of daily wear each.

Read the detailed description

This was a prospective, randomized, double masked, bilateral, crossover study. Participants were expected to attend 6 scheduled visits over a period of approximately 2 months.

02

Conditions studied

  • Astigmatism
  • Myopia

Browse trials for

03

In context

Astigmatism

413 studies on the registry are indexed under Astigmatism; 55 are open to participants now.

This study's enrollment of 36 is below the median of 55 across 321 interventional studies indexed under Astigmatism.

Browse Astigmatism studies →

Lead sponsor

CooperVision, Inc. is the lead sponsor of 37 studies on the registry; none are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 29 (94%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

A person is eligible for inclusion in the study if he/she:

  • Is between 18 and 40 years of age (inclusive)
  • Has had a self-reported visual exam in the last two years
  • Is an adapted soft contact lens wearer
  • Is not a habitual wearer of either study lens
  • Has a contact lens spherical prescription between +4.00 to - 10.00 (inclusive). Best corrected visual acuity of 20/30 or better in either eye
  • Have contact lens prescription of no less than -0.75D of astigmatism and no more than -2.25 D in both eyes.
  • Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
  • Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
  • Has clear corneas and no active ocular disease
  • Has read, understood and signed the information consent letter.
  • Patient contact lens refraction should fit within the available parameters of the study lenses.
  • Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
  • Is willing to comply with the visit schedule

Exclusion criteria

Exclusion Criteria:

A person will be excluded from the study if he/she:

  • A person was excluded from the study if he/she:
  • Has a CL prescription outside the range of the available parameters of the study lenses.
  • Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in either eye.
  • Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
  • Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
  • Presence of clinically significant (grade 2-4) anterior segment abnormalities
  • Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
  • Slit lamp findings that would contraindicate contact lens wear such as:
  • Pathological dry eye or associated findings
  • Pterygium, pinguecula, or corneal scars within the visual axis
  • Neovascularization > 0.75 mm in from of the limbus
  • Giant papillary conjunctivitis (GCP) worse than grade 1
  • Anterior uveitis or iritis (past or present)
  • Seborrheic eczema, Seborrheic conjunctivitis
  • History of corneal ulcers or fungal infections
  • Poor personal hygiene
  • Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
  • Has aphakia, keratoconus or a highly irregular cornea.
  • Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
  • Has undergone corneal refractive surgery.
  • Is participating in any other type of eye related clinical or research study.
05

Study design

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

Study arms

  • Experimental
    Lens A, then Lens B

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

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

  • Experimental
    Lens B, then Lens A

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

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

Interventions

  • DeviceLens A (fanfilcon A)

    Daily wear for one month

  • DeviceLens B (asmofilcon A)

    Daily wear for one month

06

What researchers measure

Primary outcomes

  1. Lens Handling (Insertion and Removal)

    Subjective lens handling measured ease of insertion and removal on a scale of 0-10, where 10=better performance.

    Time frame: 1 month

07

Results

Posted Aug 24, 2022

Participant flow

This study was conducted at a single investigative site located in Mexico City, Mexico.

Period 1 (One Month)
Participant flow — Period 1 (One Month)
MilestoneLens A, Then Lens BLens B, Then Lens A
Started1818
Completed1818
Not completed00
Period 2 (One Month)
Participant flow — Period 2 (One Month)
MilestoneLens A, Then Lens BLens B, Then Lens A
Started1818
Completed1818
Not completed00

Outcome measures

PrimaryLens Handling (Insertion and Removal)

Subjective lens handling measured ease of insertion and removal on a scale of 0-10, where 10=better performance.

Time frame:
1 month
Reported as:
Mean · units on a scale
Lens Handling (Insertion and Removal)
units on a scaleLens ALens B
Lens Handling (Insertion and Removal)9.47 ± 1.008.33 ± 1.54

Adverse events

Collected over For the duration of the study, approximately two months.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lens A0/36 (0%)0/36 (0%)0/36 (0%)
Lens B0/36 (0%)0/36 (0%)0/36 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)All Study Participants
Mean28.6 ± 6.8
Sex: Female, Male
Sex: Female, Male(Participants)All Study Participants
Female28
Male8
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)All Study Participants
08

Study locations

1 site
  • National Autonomous University (UNAM)
    Mexico City, Código 54090, Mexico
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Aug 19, 2021

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

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05097144
Lead sponsor
CooperVision, Inc.
Responsible party
Sponsor
First posted
Oct 28, 2021
Start date
Aug 21, 2021
Primary completion
Dec 8, 2021
Completion
Dec 8, 2021
Results posted
Aug 24, 2022
Last update
Oct 17, 2023

Study contacts

Rubén Velázquez Guerrero, MSc, FIACLE
principal investigator · National Autonomous University (UNAM)

Oversight

Data monitoring committee
Yes
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 Oct 2022. 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.

Start the discussion