Skip to main content
OpenTrials
Completed

NCT Number: NCT02406495

Clinical Performance of Habitual Wearers of Bioclear 1-day Lenses When Refitted With Biomedics 1-day Extra for 1 Week

Open label, 1-week daily disposable, dispensing study

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Optometry Research Group (GIO) Optics Department, University of Valencia

Valencia, 46100, Spain

About this study

Evaluate the clinical performance of habitual wearers of FILCON IV 1 sphere lenses when refitted with ocufilcon D asphere for 1 week of daily disposable wear.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Is between 18 and 40 years of age (inclusive)
  • Has had a self-reported visual exam in the last two years
  • Is an adapted Avaira sphere contact lens wearer (at least 1 week in Avaira sphere)
  • Has a contact lens spherical prescription between + 2.25 to - 8.00 (inclusive)
  • Has a spectacle cylinder up to 0.75D in each eye.
  • 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

  • Is not a habitual wearer of Avaira sphere lenses
  • Has a CL prescription outside the range of the available parameters of the study lenses.
  • Has a spectacle cylinder ≥1.00D 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

Treatment and study plan

filcon IV 1

Device

contact lens

ocufilcon D

Device

contact lens

Primary outcomes

  1. Lens Fit, Centration - Filcon IV 1 and Ocufilcon D

    Time frame: Baseline and 1 Week

    Lens fit, centration for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale: optimum, decentration acceptable, and decentration unacceptable

  2. Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D

    Time frame: Baseline and 1 Week

    Lens fit, post-blink movement for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week.

    (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

  3. Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D

    Time frame: Baseline and 1 Week

    Lens fit, lens tightness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week.

    Scale 0%-100% continuous scale 0% - Falls from cornea without lid support 50% - Optimum 100% - No movement

  4. Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D

    Time frame: Baseline and 1 Week

    Lens fit, overall fit acceptance for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0-4, 0=Should not be worn, 4=Perfect.

Secondary outcomes

  1. Visual Acuity - Filcon IV 1 and Ocufilcon D

    Time frame: Baseline and 1 Week

    Visual acuity for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week using logMAR chart (a logMAR of 0.0=20/20 in Snellen notation and negative values indicate better visual acuity).

  2. Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D

    Time frame: Baseline and 1 Week

    Subjective ratings for comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=could feel, 10=cannot feel).

  3. Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D

    Time frame: Baseline and 1 Week

    Subjective ratings of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dryness, 10=no dryness).

  4. Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D

    Time frame: Baseline and 1 Week

    Subjective ratings of handling for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=very difficult to handle, 10=very easy to handle).

  5. Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D

    Time frame: Baseline and 1 Week

    Subjective ratings of vision satisfaction for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dissatisfied, 10=very satisfied).

  6. Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D

    Time frame: 1 Week

    Subjective ratings of participant's lens preference for either filcon IV 1 or ocufilcon D on comfort, dryness, handling, vision, and overall. Forced choice: filcon IV 1 or ocufilcon D.

  7. Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D

    Time frame: Baseline and 1 Week

    Lens satisfaction of comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.

  8. Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D

    Time frame: Baseline and 1 Week

    Lens satisfaction of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.

  9. Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D

    Time frame: Baseline and 1 Week

    Lens satisfaction of handling forfilcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.

  10. Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D

    Time frame: Baseline and 1 Week

    Lens satisfaction of vision for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.

  11. Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D

    Time frame: Baseline and 1 Week

    Lens satisfaction overall for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 2, 2015
Registry last updated
Jul 29, 2020

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.

Published trials that share one or more normalized conditions with this study.