AIR OPTIX® COLORS Registration Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01440322
First received: September 22, 2011
Last updated: April 24, 2014
Last verified: April 2014

September 22, 2011
April 24, 2014
September 2011
January 2012   (final data collection date for primary outcome measure)
Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) [ Time Frame: Up to Month 3 ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT01440322 on ClinicalTrials.gov Archive Site
  • Subjective Rating of Overall Vision [ Time Frame: Up to Month 3 ] [ Designated as safety issue: No ]
    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.
  • Subjective Rating of Overall Comfort [ Time Frame: Up to Month 3 ] [ Designated as safety issue: No ]
    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.
  • Subjective Rating of Overall Handling [ Time Frame: Up to Month 3 ] [ Designated as safety issue: No ]
    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.
  • Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) [ Time Frame: Up to Month 3 ] [ Designated as safety issue: No ]
    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.
  • Lens Centration (Centered, Slight Decentration) [ Time Frame: Up to Month 3 ] [ Designated as safety issue: No ]
    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.
  • Dry Areas/Non-Wetting (None, Very Slight) [ Time Frame: Up to Month 3 ] [ Designated as safety issue: No ]
    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.
  • Front Surface Deposits (None, Very Slight) [ Time Frame: Up to Month 3 ] [ Designated as safety issue: No ]
    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.
  • Back Surface Deposits (None, Very Slight) [ Time Frame: Up to Month 3 ] [ Designated as safety issue: No ]
    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.
Not Provided
Not Provided
Not Provided
 
AIR OPTIX® COLORS Registration Trial
Not Provided

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Refractive Error
  • Device: Lotrafilcon B contact lens with color
    Silicone hydrogel contact lens with color
    Other Name: AIR OPTIX® COLORS
  • Device: Lotrafilcon B contact lens
    Silicone hydrogel contact lens
    Other Name: AIR OPTIX® AQUA
  • Experimental: AIR OPTIX® COLORS
    Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
    Intervention: Device: Lotrafilcon B contact lens with color
  • Active Comparator: AIR OPTIX® AQUA
    Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
    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
150
January 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01440322
P-383-C-003 (C-11-032)
No
Alcon Research ( CIBA VISION )
CIBA VISION
Not Provided
Study Director: Sharon Holden Thomas, OD Alcon Research
Alcon Research
April 2014

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