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Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01293240
First Posted: February 10, 2011
Last Update Posted: July 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
  Purpose
The purpose of this study is to compare the overall performance of a monthly replacement contact lens when worn for one month and when worn for two weeks.

Condition Intervention
Myopia Astigmatism Presbyopia Device: lotrafilcon B contact lens

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks

Resource links provided by NLM:


Further study details as provided by Alcon Research ( CIBA VISION ):

Primary Outcome Measures:
  • Overall Comfort [ Time Frame: 2 weeks ]
    Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.

  • Overall Comfort [ Time Frame: 4 weeks ]
    Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.

  • End of Day Dryness [ Time Frame: 2 weeks ]
    End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.

  • End of Day Dryness [ Time Frame: 4 weeks ]
    End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.

  • Ocular Redness [ Time Frame: 2 weeks ]
    Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red.

  • Ocular Redness [ Time Frame: 4 weeks ]
    Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red.

  • Visual Clarity [ Time Frame: 2 weeks ]
    Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent.

  • Visual Clarity [ Time Frame: 4 weeks ]
    Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent.

  • Lens Deposits [ Time Frame: 2 weeks ]
    Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe.

  • Lens Deposits [ Time Frame: 4 weeks ]
    Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe.

  • Corrected Visual Acuity [ Time Frame: 2 weeks ]
    Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.

  • Corrected Visual Acuity [ Time Frame: 4 weeks ]
    Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.


Enrollment: 117
Study Start Date: December 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lotrafilcon B Device: lotrafilcon B contact lens
Commercially marketed, silicone hydrogel contact lens worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
Other Name: AIR OPTIX® AQUA, AIR OPTIX® for ASTIGMATISM, AIR OPTIX® AQUA MULTIFOCAL

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Habitual and successful wearers of contact lenses made of lotrafilcon B material for at least 4 weeks prior to enrollment.
  • Good general health.
  • Sphere requirement in the range +6.00 to -10.00 with astigmatism or multifocal correction or no astigmatism or multifocal correction.
  • Ability to comply with all protocol-mandated procedures and to attend all scheduled office visits.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Anterior segment abnormalities (i.e., cataracts, opacities, etc.) or active anterior segment disease.
  • Administration of any investigational drug or device within 14 days of study initiation.
  • Use of any eye drops with a pharmacological effect within 7 days of Visit 1.
  • Known local or systemic hypersensitivity to contact lens cleaning and disinfecting solutions.
  • Post-refractive surgery.
  • Currently pregnant or lactating by case history.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT01293240     History of Changes
Other Study ID Numbers: P-368-C-400
First Submitted: February 9, 2011
First Posted: February 10, 2011
Results First Submitted: May 1, 2012
Results First Posted: June 1, 2012
Last Update Posted: July 10, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Astigmatism
Presbyopia
Refractive Errors
Eye Diseases