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Completed

NCT Number: NCT01440322

AIR OPTIX® COLORS Registration Trial

The purpose of this study was to evaluate the subjective and objective performance and the physiological response to AIR OPTIX® COLORS soft contact lenses compared with AIR OPTIX® AQUA contact lenses in participants with normal eyes and prescription needs.

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Key information

Conditions

Refractive Error Eye Diseases Myopia Refractive Errors

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This study consisted of 7 scheduled visits conducted over a 3-month period. Enrolled participants were randomized (2:1) to receive either AIR OPTIX® COLORS lenses in both eyes or AIR OPTIX® AQUA lenses in both eyes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
  • Normal eyes and not using any ocular medications.
  • Willing to wear visitint or gray-colored spherical contact lenses in both eyes within available power ranges.
  • Manifest cylinder less than or equal to 0.75 diopter.
  • Best spectacle corrected visual acuity greater than or equal to 20/25.
  • Have current prescription glasses.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Anterior segment infection, inflammation, or abnormality.
  • Any active anterior segment ocular or systemic disease that would contraindicate contact lens wear.
  • Use of ocular or systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
  • History of refractive surgery or irregular cornea.
  • History of pathologically dry eye.
  • Corneal vascularization greater than 1 millimeter of penetration.
  • History of herpetic keratitis.
  • Eye injury within 12 weeks immediately prior to enrollment in this trial.
  • Currently enrolled in any clinical trial or participation in any clinical trial within the previous 30 days.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Lotrafilcon B contact lens with color

Device

Silicone hydrogel contact lens with color

Other names: AIR OPTIX® COLORS

Lotrafilcon B contact lens

Device

Silicone hydrogel contact lens

Other names: AIR OPTIX® AQUA

Primary outcomes

  1. Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)

    Time frame: Up to Month 3

    Visual acuity, as assessed for each eye individually. Participant read a distance Snellen chart while wearing study lenses. The percentage of eyes with VA recorded as 20/30 or better is reported. Both eyes contributed to the percentage.

Secondary outcomes

  1. Subjective Rating of Overall Vision

    Time frame: Up to Month 3

    Overall vision, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.

  2. Subjective Rating of Overall Comfort

    Time frame: Up to Month 3

    Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.

  3. Subjective Rating of Overall Handling

    Time frame: Up to Month 3

    Overall handling, as rated by the participant on a 10-point scale, with 1 being difficult and 10 being easy. The participant rated both eyes together by providing one single rating.

  4. Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)

    Time frame: Up to Month 3

    Lens fit, as assessed by the investigator for each eye individually. Lens fit was rated on a 5-point scale: 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, -2=unacceptably tight. The combined percentage of lenses assessed as "optimal," "acceptably loose," or "acceptably tight" is reported. Lenses from both eyes contributed to the percentage.

  5. Lens Centration (Centered, Slight Decentration)

    Time frame: Up to Month 3

    Lens centration, as assessed by the investigator for each eye individually. Lens centration was rated on a 5-point scale: 0=centered, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage.

  6. Dry Areas/Non-Wetting (None, Very Slight)

    Time frame: Up to Month 3

    Dry areas/non-wetting (i.e., assessment of the disruption of the front surface wettability of the contact lens), as assessed by the investigator for each eye individually. Dry areas/non-wetting was rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage.

  7. Front Surface Deposits (None, Very Slight)

    Time frame: Up to Month 3

    Front surface deposits on the contact lens, as assessed by the investigator for each eye individually. Front surface deposits were rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage.

  8. Back Surface Deposits (None, Very Slight)

    Time frame: Up to Month 3

    Back surface deposits on the contact lens, as assessed by the investigator for each eye individually. Back surface deposits were rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage.

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 26, 2011
Registry last updated
May 8, 2014

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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