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
  Purpose

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.


Condition Intervention
Hyperopia
Device: Acuvue Advance Plus
Device: Acuvue Advance

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 38
Study Start Date: October 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Acuvue Advance Plus/ Acuvue Advance
Acuvue Advance Plus contact lenses worn first period and Acuvue Advance contact lenses worn second.
Device: Acuvue Advance Plus
Silicone hydrogel contact lens.
Device: Acuvue Advance
Silicone hydrogel contact lens
Acuvue Advance/Acuvue Advance Plus
Acuvue Advance contact lenses worn first period and Acuvue Advance Plus contact lenses worn second.
Device: Acuvue Advance Plus
Silicone hydrogel contact lens.
Device: Acuvue Advance
Silicone hydrogel contact lens

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228591

Locations
United States, Florida
Winter Park, Florida, United States
United States, New York
New York, New York, United States
United States, Pennsylvania
Nanticoke, Pennsylvania, United States
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01228591     History of Changes
Other Study ID Numbers: CR-1636BB
Study First Received: October 22, 2010
Results First Received: September 17, 2013
Last Updated: February 6, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 19, 2014