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

July 19, 2020 updated by: Coopervision, Inc.
Open label, 1-week daily disposable, dispensing study

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Valencia, Spain, 46100
        • Optometry Research Group (GIO) Optics Department, University of Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 1 Week
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).

Baseline and 1 Week
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

Baseline and 1 Week
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.
Baseline and 1 Week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline and 1 Week
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).
Baseline and 1 Week
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).
Baseline and 1 Week
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).
Baseline and 1 Week
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).
Baseline and 1 Week
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.
1 Week
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.
Baseline and 1 Week
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.
Baseline and 1 Week
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.
Baseline and 1 Week
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.
Baseline and 1 Week
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.
Baseline and 1 Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Robert Montés-Mico, OD MPhil PhD, Optometry Research Group (GIO) Optics Department, University of Valencia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

March 30, 2015

First Submitted That Met QC Criteria

March 30, 2015

First Posted (Estimate)

April 2, 2015

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 19, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EX-MKTG-58

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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