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Trial record 27 of 328 for:    contact lens | Studies With Results

A Comparison of Two Color Contact Lenses in Habitual Clear Contact Lens Wearers

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ClinicalTrials.gov Identifier: NCT02175199
Recruitment Status : Completed
First Posted : June 26, 2014
Results First Posted : October 14, 2015
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant)
Condition: Myopia
Interventions: Device: Lotrafilcon B contact lenses with color printing
Device: Phemfilcon A contact lenses with color printing

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from 10 Study Centers located in the US.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 151 enrolled, 1 subject was exited as a screen failure prior to randomization. This reporting group includes all randomized subjects (150).

Reporting Groups
  Description
AIR OPTIX COLORS Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
FreshLook COLORBLENDS Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days with a 2-week replacement.

Participant Flow:   Overall Study
    AIR OPTIX COLORS   FreshLook COLORBLENDS
STARTED   74   76 
Dispensed   72 [1]   74 [1] 
COMPLETED   71   71 
NOT COMPLETED   3   5 
Withdrawal by Subject                1                5 
Randomized in Error                1                0 
Sponsor Decision                1                0 
[1] Two subjects were randomized but never dispensed study lenses.



  Baseline Characteristics

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.
This analysis population includes all subjects / eyes exposed to any test articles evaluated in this study.

Reporting Groups
  Description
AIR OPTIX COLORS Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
FreshLook COLORBLENDS Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days with a 2-week replacement.
Total Total of all reporting groups

Baseline Measures
   AIR OPTIX COLORS   FreshLook COLORBLENDS   Total 
Overall Participants Analyzed 
[Units: Participants]
 72   74   146 
Age 
[Units: Years]
Mean (Standard Deviation)
 29.9  (7.91)   29.4  (7.62)   29.7  (7.74) 
Gender 
[Units: Participants]
     
Female   67   60   127 
Male   5   14   19 


  Outcome Measures

1.  Primary:   Lens Comfort Likert Response at Day 30   [ Time Frame: Day 30 ]

2.  Secondary:   Lens Comfort Likert Response at Day 14   [ Time Frame: Day 14 ]

3.  Secondary:   Lens Comfort 1-10 Scale Response   [ Time Frame: Day 30 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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: Global Brand Lead, GCRA, Vision Care
Organization: Alcon Research, Ltd.
phone: 1-888-451-3937
e-mail: alcon.medinfo@alcon.com



Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02175199     History of Changes
Other Study ID Numbers: M-14-008
First Submitted: June 24, 2014
First Posted: June 26, 2014
Results First Submitted: September 14, 2015
Results First Posted: October 14, 2015
Last Update Posted: October 14, 2015