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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
  Purpose

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.


Condition Intervention
Refractive Error
Device: Lotrafilcon B contact lens with color
Device: Lotrafilcon B contact lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 150
Study Start Date: September 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AIR OPTIX® COLORS
Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
Device: Lotrafilcon B contact lens with color
Silicone hydrogel contact lens with color
Other Name: AIR OPTIX® COLORS
Active Comparator: AIR OPTIX® AQUA
Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
Device: Lotrafilcon B contact lens
Silicone hydrogel contact lens
Other Name: AIR OPTIX® AQUA

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440322

Sponsors and Collaborators
CIBA VISION
Investigators
Study Director: Sharon Holden Thomas, OD Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01440322     History of Changes
Other Study ID Numbers: P-383-C-003 (C-11-032)
Study First Received: September 22, 2011
Results First Received: February 18, 2014
Last Updated: April 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Myopia
Contact lenses

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on November 27, 2014