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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01293240
First received: February 9, 2011
Last updated: June 26, 2012
Last verified: May 2012

February 9, 2011
June 26, 2012
December 2010
April 2011   (final data collection date for primary outcome measure)
  • Overall Comfort [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Objective Visual Acuity [ Time Frame: 2 weeks of wear and 4 weeks of wear ] [ Designated as safety issue: No ]
Visual acuity, as measured using the distance Snellen charts.
Complete list of historical versions of study NCT01293240 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks
Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Myopia
  • Astigmatism
  • Presbyopia
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
Experimental: Lotrafilcon B
Intervention: Device: lotrafilcon B contact lens
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
117
April 2011
April 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01293240
P-368-C-400
No
Alcon Research ( CIBA VISION )
CIBA VISION
Not Provided
Not Provided
Alcon Research
May 2012

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