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OpenTrials
Completed

NCT Number: NCT01228591

Pilot Dispensing Evaluation of a Plus Power Lens

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Winter Park, Florida, United States

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Acuvue Advance Plus

Device

Silicone hydrogel contact lens.

Acuvue Advance

Device

Silicone hydrogel contact lens

Primary outcomes

  1. Visual Acuity One Week After Lens Wear

    Time frame: 1 week

    Visual acuity was measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study. Binocular and monocular measurements were collected.

  2. Visual Acuity at Time of Initial Fit

    Time frame: After 10-15 minutes of lens wear

    Visual acuity will be measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study.

Secondary outcomes

  1. Contact Lens Comfort Using Contact Lens User Experience (CLUE)

    Time frame: 1 week

    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.

  2. Subject Reported Vision Using Contact Lens User Experience (CLUE).

    Time frame: 1 week

    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.

  3. Contact Lens Comfort at Initial Fit Using Contact Lens User Experience (CLUE)

    Time frame: Baseline

    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.

  4. Subject Reported Vision at Initial Fit Using Contact Lens User Experience (CLUE)

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Oct 26, 2010
Registry last updated
Jun 19, 2018

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.

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