Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02406495
Recruitment Status : Completed
First Posted : April 2, 2015
Results First Posted : May 3, 2016
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Open label, 1-week daily disposable, dispensing study

Condition or disease Intervention/treatment Phase
Myopia Hyperopia Device: filcon IV 1 Device: ocufilcon D Not Applicable

Detailed Description:
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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Clinical Performance of Habitual Wearers of Bioclear 1-day Lenses When Refitted With Biomedics 1-day Extra for 1 Week
Study Start Date : April 2015
Actual Primary Completion Date : April 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: filcon IV 1 and ocufilcon D
Habitual wearers of filcon IV 1 sphere lenses refitted with asphere ocufilcon D lenses.
 Device: filcon IV 1
contact lens

Device: ocufilcon D
contact lens


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02406495


Locations
Layout table for location information
Spain
Optometry Research Group (GIO) Optics Department, University of Valencia
Valencia, Spain, 46100
Sponsors and Collaborators
Coopervision, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Robert Montés-Mico, OD MPhil PhD Optometry Research Group (GIO) Optics Department, University of Valencia
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT02406495    
Other Study ID Numbers: EX-MKTG-58
First Posted: April 2, 2015    Key Record Dates
Results First Posted: May 3, 2016
Last Update Posted: July 29, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperopia
Refractive Errors
Eye Diseases