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OpenTrials
Completed

NCT Number: NCT02921412

Performance of Fanfilcon A Toric Lenses After at Least One Month Wearing Enfilcon A Toric Lenses

This is a prospective, multi-center, subject-masked, bilateral, daily wear, two-month dispensing study

Completed

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Contact Lens Service, Miami, Florida, United States

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About this study

The aim of this study is to determine if adapted contact lens wearers enfilcon A toric lenses can be confidently refit into fanfilcon A toric lenses and can be successful after one month of daily wear.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 eye exam in the last two years
  • Is a habitual soft toric lens wearer
  • Can be successfully fit with study lenses (≥ grade 2 fit acceptance)
  • Has a contact lens spherical prescription between -1.00 to -6.00D with a cylinder between -0.75 and -1.75D (Diopters) (inclusive)
  • Has a spectacle cylinder of at least 0.75D in each eye.
  • Can achieve best corrected spectacle refraction 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
  • Has a contact lens refraction that fits 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

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

  • Has a history of not achieving comfortable CL (Contact Lens) wear (5 days per week; > 8 hours/day)
  • Presents with clinically significant anterior segment abnormalities
  • Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear
  • Presents with slit lamp findings that would contraindicate contact lens wear such as:
  • Pathological dry eye or associated findings
  • Significant pterygium, pinguecula, or corneal scars within the visual axis
  • Neovascularization > 0.75 mm in from of the limbus
  • Anterior uveitis or iritis (or history in past year)
  • Seborrheic eczema of eyelid region, 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.
  • Is frequently using rewetting/ lubricating eye drops (more than once per day)

Treatment and study plan

fanfilcon A

Device

contact lens

Primary outcomes

  1. Visual Acuity

    Time frame: baseline, 2 weeks, 1 month

    High contrast distance visual acuity is measured by LogMAR.

  2. Centration

    Time frame: baseline, 2 weeks, 1 month

    Lens centration is assessed (optimum, decentration acceptable, decentration unacceptable).

  3. Corneal Coverage

    Time frame: baseline, 2 weeks, 1 month

    Corneal coverage will be assessed (yes/no)

  4. Post-blink Movement

    Time frame: baseline, 2 weeks, 1 month

    Post-blink lens movement assessed using the following evaluations (0-4): 0=Insufficient, unacceptable, 1=Minimal, acceptable, 2=Optimal, 3=Moderate, acceptable, 4=Excessive, unacceptable)

  5. Fit Acceptability

    Time frame: baseline, 2 weeks, 1 month

    Investigator fit acceptability for each lens pair. Scale 0-4: (0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 3, 2016
Registry last updated
Apr 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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