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Prospective Study of an Investigational Toric Soft Contact Lens

Primary Purpose

Myopia, Astigmatism, Refractive Error

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nelfilcon A toric contact lenses (with comfort additives)
Nelfilcon A toric contact lenses
Sponsored by
CIBA VISION
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring toric, contact lenses, daily disposable contact lenses, astigmatism, soft contact lenses, contact lens comfort

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and participant must sign Assent document.
  • Normal eyes not using any ocular medications that would contraindicate lens wear.
  • Willing and able to wear toric contact lenses in both eyes within the available range of powers for this trial.
  • Spectacle cylinder prescription between 0.50 and 2.00 diopters.
  • Best spectacle corrected visual acuity 20/25 (Snellen) or better in each eye at distance.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Anterior segment infection, inflammation, or abnormality.
  • Any active anterior segment or systemic disease that would contraindicate contact lens wear.
  • Use of systemic medications that would contraindicate lens wear.
  • Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the study lenses or affect the results of this study.
  • History of herpetic keratitis.
  • History of refractive surgery or irregular cornea.
  • History of pathologically dry eye.
  • Corneal vascularization greater than 1 mm of penetration.
  • Eye injury within twelve weeks immediately prior to enrollment in this trial.
  • Participation in a contact lens or contact lens care product clinical trial within the previous 30 days, or concurrent participation in any clinical trial.
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    DAILIES® AquaComfort Plus® Toric

    Focus® DAILIES® Toric

    Arm Description

    Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months

    Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months

    Outcomes

    Primary Outcome Measures

    Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)
    Visual acuity, as assessed for each eye individually. Participant read a distance Snellen chart while wearing study lenses. The percentage of eyes with VA recorded as 20/30 or better is reported. Both eyes contributed to the percentage.

    Secondary Outcome Measures

    Subjective Rating of Insertion Comfort
    Insertion comfort (30 seconds to 1 minute), as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.
    Subjective Rating of End of Day Comfort
    End of day comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.
    Subjective Rating of Overall Comfort
    Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.
    Subjective Rating of End of Day Dryness
    End of day dryness, as rated by the participant on a 10-point scale, with 1 being dry and 10 being not dry. The participant rated both eyes together by providing one single rating.
    Subjective Rating of Overall Vision
    Overall vision, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.
    Subjective Rating of Overall Handling
    Overall handling, as rated by the participant on a 10-point scale, with 1 being difficult and 10 being easy. The participant rated both eyes together by providing one single rating.
    Lens Centration (Centered, Slight Decentration)
    Lens centration, as assessed by the investigator for each eye individually. Lens centration was graded on a 5-point scale: 0=centered, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage.
    Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)
    Lens fit, as assessed by the investigator for each eye individually. Lens fit was graded on a 5-point scale: 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight. The combined percentage of lenses assessed as "optimal," "acceptably loose," or "acceptably tight" is reported. Lenses from both eyes contributed to the percentage.
    Front Surface Wettability (None, Very Slight)
    Front surface wettability (i.e., assessment of the disruption of the front surface wettability of the contact lens), as assessed by the investigator for each eye individually. Front surface wettability was graded on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage.
    Front Surface Deposits (None, Very Slight)
    Front surface deposits on the contact lens, as assessed by the investigator for each eye individually. Front surface deposits were graded on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage.
    Back Surface Debris/Deposits (None, Very Slight)
    Back surface debris/deposits on the contact lens, as assessed by the investigator for each eye individually. Back surface debris/deposits were graded on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage.

    Full Information

    First Posted
    October 26, 2011
    Last Updated
    August 9, 2013
    Sponsor
    CIBA VISION
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01461811
    Brief Title
    Prospective Study of an Investigational Toric Soft Contact Lens
    Official Title
    ARES Registration Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2011 (undefined)
    Primary Completion Date
    April 2012 (Actual)
    Study Completion Date
    April 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    CIBA VISION

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study was to demonstrate substantial equivalence of an investigational toric soft contact lens to the commercially available Focus® DAILIES® Toric soft contact lens when worn in a daily wear, daily disposable mode for three months.
    Detailed Description
    Eligible participants were randomized 2:1 to wear either DAILIES® AquaComfort Plus® Toric or Focus® DAILIES® Toric.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia, Astigmatism, Refractive Error
    Keywords
    toric, contact lenses, daily disposable contact lenses, astigmatism, soft contact lenses, contact lens comfort

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    154 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DAILIES® AquaComfort Plus® Toric
    Arm Type
    Experimental
    Arm Description
    Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
    Arm Title
    Focus® DAILIES® Toric
    Arm Type
    Active Comparator
    Arm Description
    Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
    Intervention Type
    Device
    Intervention Name(s)
    Nelfilcon A toric contact lenses (with comfort additives)
    Intervention Type
    Device
    Intervention Name(s)
    Nelfilcon A toric contact lenses
    Other Intervention Name(s)
    Focus® DAILIES® Toric
    Primary Outcome Measure Information:
    Title
    Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)
    Description
    Visual acuity, as assessed for each eye individually. Participant read a distance Snellen chart while wearing study lenses. The percentage of eyes with VA recorded as 20/30 or better is reported. Both eyes contributed to the percentage.
    Time Frame
    Up to Month 3
    Secondary Outcome Measure Information:
    Title
    Subjective Rating of Insertion Comfort
    Description
    Insertion comfort (30 seconds to 1 minute), as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.
    Time Frame
    Up to Month 3
    Title
    Subjective Rating of End of Day Comfort
    Description
    End of day comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.
    Time Frame
    Up to Month 3
    Title
    Subjective Rating of Overall Comfort
    Description
    Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.
    Time Frame
    Up to Month 3
    Title
    Subjective Rating of End of Day Dryness
    Description
    End of day dryness, as rated by the participant on a 10-point scale, with 1 being dry and 10 being not dry. The participant rated both eyes together by providing one single rating.
    Time Frame
    Up to Month 3
    Title
    Subjective Rating of Overall Vision
    Description
    Overall vision, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.
    Time Frame
    Up to Month 3
    Title
    Subjective Rating of Overall Handling
    Description
    Overall handling, as rated by the participant on a 10-point scale, with 1 being difficult and 10 being easy. The participant rated both eyes together by providing one single rating.
    Time Frame
    Up to Month 3
    Title
    Lens Centration (Centered, Slight Decentration)
    Description
    Lens centration, as assessed by the investigator for each eye individually. Lens centration was graded on a 5-point scale: 0=centered, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage.
    Time Frame
    Up to Month 3
    Title
    Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)
    Description
    Lens fit, as assessed by the investigator for each eye individually. Lens fit was graded on a 5-point scale: 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight. The combined percentage of lenses assessed as "optimal," "acceptably loose," or "acceptably tight" is reported. Lenses from both eyes contributed to the percentage.
    Time Frame
    Up to Month 3
    Title
    Front Surface Wettability (None, Very Slight)
    Description
    Front surface wettability (i.e., assessment of the disruption of the front surface wettability of the contact lens), as assessed by the investigator for each eye individually. Front surface wettability was graded on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage.
    Time Frame
    Up to Month 3
    Title
    Front Surface Deposits (None, Very Slight)
    Description
    Front surface deposits on the contact lens, as assessed by the investigator for each eye individually. Front surface deposits were graded on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage.
    Time Frame
    Up to Month 3
    Title
    Back Surface Debris/Deposits (None, Very Slight)
    Description
    Back surface debris/deposits on the contact lens, as assessed by the investigator for each eye individually. Back surface debris/deposits were graded on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage.
    Time Frame
    Up to Month 3

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and participant must sign Assent document. Normal eyes not using any ocular medications that would contraindicate lens wear. Willing and able to wear toric contact lenses in both eyes within the available range of powers for this trial. Spectacle cylinder prescription between 0.50 and 2.00 diopters. Best spectacle corrected visual acuity 20/25 (Snellen) or better in each eye at distance. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Anterior segment infection, inflammation, or abnormality. Any active anterior segment or systemic disease that would contraindicate contact lens wear. Use of systemic medications that would contraindicate lens wear. Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the study lenses or affect the results of this study. History of herpetic keratitis. History of refractive surgery or irregular cornea. History of pathologically dry eye. Corneal vascularization greater than 1 mm of penetration. Eye injury within twelve weeks immediately prior to enrollment in this trial. Participation in a contact lens or contact lens care product clinical trial within the previous 30 days, or concurrent participation in any clinical trial. Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mary Fahmy, OD
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Prospective Study of an Investigational Toric Soft Contact Lens

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