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OpenTrials
Completed

NCT Number: NCT01293240

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.

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Key information

Conditions

Myopia Astigmatism Eye Diseases Presbyopia Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Lotrafilcon B contact lens

Device

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 names: AIR OPTIX® AQUA, AIR OPTIX® for ASTIGMATISM, AIR OPTIX® AQUA MULTIFOCAL

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 10, 2011
Registry last updated
Jul 10, 2012

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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