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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
Enrollment 151
Recruitment Details Subjects were recruited from 10 Study Centers located in the US.
Pre-assignment Details Of the 151 enrolled, 1 subject was exited as a screen failure prior to randomization. This reporting group includes all randomized subjects (150).
Arm/Group Title AIR OPTIX COLORS FreshLook COLORBLENDS
Hide Arm/Group Description Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days. 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.
Period Title: Overall Study
Started 74 76
Dispensed 72 [1] 74 [1]
Completed 71 71
Not Completed 3 5
Reason Not Completed
Withdrawal by Subject             1             5
Randomized in Error             1             0
Sponsor Decision             1             0
[1]
Two subjects were randomized but never dispensed study lenses.
Arm/Group Title AIR OPTIX COLORS FreshLook COLORBLENDS Total
Hide Arm/Group Description Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days. 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 of all reporting groups
Overall Number of Baseline Participants 72 74 146
Hide Baseline Analysis Population Description
This analysis population includes all subjects / eyes exposed to any test articles evaluated in this study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants 74 participants 146 participants
29.9  (7.91) 29.4  (7.62) 29.7  (7.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 74 participants 146 participants
Female
67
  93.1%
60
  81.1%
127
  87.0%
Male
5
   6.9%
14
  18.9%
19
  13.0%
1.Primary Outcome
Title Lens Comfort Likert Response at Day 30
Hide Description Subject indicated agreement with the following statement, "These lenses provided the same excellent comfort at the end of the month as they did at the beginning of the month" using a 4-point Likert scale, where 1=Strongly disagree, 2=Disagree; 3=Agree; 4=Strongly agree. The Top 2 responses (agree, strongly agree) were calculated and reported as a percentage of all responses. Both eyes were rated together. This outcome measure was prespecified for the AIR OPTIX COLORS arm only.
Time Frame Day 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).
Arm/Group Title AIR OPTIX COLORS
Hide Arm/Group Description:
Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
Overall Number of Participants Analyzed 70
Measure Type: Number
Unit of Measure: percentage of subjects
81.4
2.Secondary Outcome
Title Lens Comfort Likert Response at Day 14
Hide Description Subject indicated agreement with the following statement, "These lenses provided the same excellent comfort at the end of two weeks as they did at the beginning of the two weeks" using a 4-point Likert scale, where 1=Strongly disagree, 2=Disagree; 3=Agree; 4=Strongly agree. The Top 2 responses (agree, strongly agree) were calculated and reported as a percentage of all responses. Both eyes were rated together. This outcome measure is prespecified for the AIR OPTIX COLORS arm only.
Time Frame Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all randomized subjects with data at visit excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).
Arm/Group Title AIR OPTIX COLORS
Hide Arm/Group Description:
Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
Overall Number of Participants Analyzed 69
Measure Type: Number
Unit of Measure: percentage of subjects
89.9
3.Secondary Outcome
Title Lens Comfort 1-10 Scale Response
Hide Description Subject was instructed, "Please rate your comfort with the study lenses," using a scale from 1-10, where 1=poor and 10=excellent. Both eyes were rated together.
Time Frame Day 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all randomized subjects with data at visit excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).
Arm/Group Title AIR OPTIX COLORS FreshLook COLORBLENDS
Hide Arm/Group Description:
Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
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.
Overall Number of Participants Analyzed 70 70
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.0  (1.99) 7.3  (2.19)
Time Frame Adverse events (AEs) were collected for the duration of the study (3 months). AEs were reported by the subject and/or observed by the investigator as pre-treatment and treatment-emergent.
Adverse Event Reporting Description An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device.
 
Arm/Group Title Pre-treatment AIR OPTIX COLORS FreshLook COLORBLENDS
Hide Arm/Group Description Includes all subjects prior to the exposure to the investigational or control products Includes all eyes exposed to AIR OPTIX® COLORS contact lenses Includes all eyes exposed to FreshLook® COLORBLENDS® contact lenses
All-Cause Mortality
Pre-treatment AIR OPTIX COLORS FreshLook COLORBLENDS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pre-treatment AIR OPTIX COLORS FreshLook COLORBLENDS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/151 (0.00%)   0/144 (0.00%)   0/148 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pre-treatment AIR OPTIX COLORS FreshLook COLORBLENDS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/151 (0.00%)   0/144 (0.00%)   0/148 (0.00%) 
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.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Name/Title: Global Brand Lead, GCRA, Vision Care
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
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