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Pilot Dispensing Evaluation of a Plus Power Lens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01228591
First received: October 22, 2010
Last updated: February 6, 2014
Last verified: February 2014

October 22, 2010
February 6, 2014
October 2010
November 2010   (final data collection date for primary outcome measure)
  • Visual Acuity One Week After Lens Wear [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Visual acuity was measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study. Binocular and monocular measurements were collected.
  • Visual Acuity at Time of Initial Fit [ Time Frame: After 10-15 minutes of lens wear ] [ Designated as safety issue: No ]
    Visual acuity will be measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study.
  • Visual Acuity [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Visual acuity will be measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study.
  • Visual Acuity [ Time Frame: first day of study ] [ Designated as safety issue: No ]
    Visual acuity will be measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study.
Complete list of historical versions of study NCT01228591 on ClinicalTrials.gov Archive Site
  • Contact Lens Comfort Using Contact Lens User Experience (CLUE) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120.
  • Subject Reported Vision Using Contact Lens User Experience (CLUE). [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Overall vision was assessed by a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120.
  • Contact Lens Comfort at Initial Fit Using Contact Lens User Experience (CLUE) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Comfort was assessed using a subjective comfort questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. CLUE scores have a range of 0-120.
  • Subject Reported Vision at Initial Fit Using Contact Lens User Experience (CLUE) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Vision at initial fit was assessed using a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120.
  • Contact lens comfort [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Subject reported vision. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Contact lens comfort [ Time Frame: first day of study ] [ Designated as safety issue: No ]
  • Subject reported vision [ Time Frame: first day of study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Pilot Dispensing Evaluation of a Plus Power Lens
Not Provided

The purpose of this study is to compare the performance of the ACUVUE® ADVANCE® Plus lenses against ACUVUE® ADVANCE® lenses in the plus power parameters.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Hyperopia
  • Device: Acuvue Advance Plus
    Silicone hydrogel contact lens.
  • Device: Acuvue Advance
    Silicone hydrogel contact lens
  • Acuvue Advance Plus/ Acuvue Advance
    Acuvue Advance Plus contact lenses worn first period and Acuvue Advance contact lenses worn second.
    Interventions:
    • Device: Acuvue Advance Plus
    • Device: Acuvue Advance
  • Acuvue Advance/Acuvue Advance Plus
    Acuvue Advance contact lenses worn first period and Acuvue Advance Plus contact lenses worn second.
    Interventions:
    • Device: Acuvue Advance Plus
    • Device: Acuvue Advance
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
November 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The subject must be at least 18 years of age and no more than 45 years of age.
  • The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study (defined as a minimum of 6 hours with a minimum of at least 1 month's wear prior to the study).
  • The subject's optimal verified spherical equivalent distance correction must be between +1.00 and + 6.00D.
  • Any cylinder power must be ≤ 0.75D.
  • The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
  • The subject must read and sign the Statement of Informed Consent.
  • The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol.

Exclusion Criteria:

  • Ocular or systemic allergies or disease which might interfere with contact lens wear.
  • Systemic disease or use of medication which might interfere with contact lens wear.
  • Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
  • Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
  • Any ocular infection.
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  • Pregnancy or lactation.
  • Diabetes.
  • Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
  • Habitual contact lens type is toric, bifocal, in monovision contact lens wear, or is worn as extended wear.
  • Need any near correction.
Both
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01228591
CR-1636BB
No
Vistakon
Vistakon
Not Provided
Not Provided
Vistakon
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP