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
Results First Received: February 18, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label
Condition: Refractive Error
Interventions: Device: Lotrafilcon B contact lens with color
Device: Lotrafilcon B contact lens

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from 10 investigational centers located in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 150 participants enrolled, 3 were exited from the study as screen failures prior to study product dispense. This reporting group includes all randomized and dispensed participants (147).

Reporting Groups
  Description
AIR OPTIX® COLORS Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
AIR OPTIX® AQUA Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months

Participant Flow:   Overall Study
    AIR OPTIX® COLORS     AIR OPTIX® AQUA  
STARTED     97     50  
COMPLETED     90     49  
NOT COMPLETED     7     1  
Discomfort                 2                 0  
Biomicroscopy                 1                 0  
Symptoms and Problems                 1                 0  
Unacceptable Subjective Vision                 1                 0  
Other Product Related                 1                 0  
Unrelated Medical Problem                 0                 1  
Other Non-Product Related                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis population includes all enrolled participants.

Reporting Groups
  Description
AIR OPTIX® COLORS Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
AIR OPTIX® AQUA Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
Total Total of all reporting groups

Baseline Measures
    AIR OPTIX® COLORS     AIR OPTIX® AQUA     Total  
Number of Participants  
[units: participants]
  100     50     150  
Age  
[units: years]
Mean ± Standard Deviation
  31.0  ± 10.28     31.0  ± 9.91     31.0  ± 10.13  
Gender  
[units: participants]
     
Female     76     34     110  
Male     24     16     40  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)   [ Time Frame: Up to Month 3 ]

2.  Secondary:   Subjective Rating of Overall Vision   [ Time Frame: Up to Month 3 ]

3.  Secondary:   Subjective Rating of Overall Comfort   [ Time Frame: Up to Month 3 ]

4.  Secondary:   Subjective Rating of Overall Handling   [ Time Frame: Up to Month 3 ]

5.  Secondary:   Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)   [ Time Frame: Up to Month 3 ]

6.  Secondary:   Lens Centration (Centered, Slight Decentration)   [ Time Frame: Up to Month 3 ]

7.  Secondary:   Dry Areas/Non-Wetting (None, Very Slight)   [ Time Frame: Up to Month 3 ]

8.  Secondary:   Front Surface Deposits (None, Very Slight)   [ Time Frame: Up to Month 3 ]

9.  Secondary:   Back Surface Deposits (None, Very Slight)   [ Time Frame: Up to Month 3 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Sharon Holden Thomas, Sr. Principal Clinical Scientist
Organization: Alcon Research, Ltd.
phone: 1-888-451-3937
e-mail: alcon.medinfo@alcon.com


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