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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01782482
Recruitment Status : Completed
First Posted : February 4, 2013
Results First Posted : March 28, 2014
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant)
Conditions Myopia
Refractive Error
Interventions Device: Lotrafilcon B contact lens with color
Device: Phemfilcon A contact lens with color
Enrollment 574
Recruitment Details Participants were recruited from 30 study centers, located in the United States.
Pre-assignment Details Of the 574 enrolled, 13 participants did not meet all inclusion/exclusion criteria and were exited as screen failures. This reporting group includes all enrolled and randomized participants (561).
Arm/Group Title AIR OPTIX® COLORS FRESHLOOK® COLORBLENDS
Hide Arm/Group Description Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
Period Title: Overall Study
Started 281 280
Completed 271 270
Not Completed 10 10
Reason Not Completed
Adverse Event             2             1
Lost to Follow-up             2             3
Physician Decision             1             0
Protocol Violation             1             0
Withdrawal by Subject             2             3
Randomized in Error             2             2
Habitually wearing toric lens OS             0             1
Arm/Group Title AIR OPTIX® COLORS FRESHLOOK® COLORBLENDS Total
Hide Arm/Group Description Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. Total of all reporting groups
Overall Number of Baseline Participants 278 274 552
Hide Baseline Analysis Population Description
The analysis population includes all randomized participants who satisfied specific Inclusion/Exclusion Criteria, did not sleep overnight in study lenses, and used only the habitual lens care during the study (552).
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 278 participants 274 participants 552 participants
16-17 years 11 11 22
18-64 years 267 263 530
≥65 years 0 0 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 278 participants 274 participants 552 participants
Female
247
  88.8%
254
  92.7%
501
  90.8%
Male
31
  11.2%
20
   7.3%
51
   9.2%
1.Primary Outcome
Title Subjective Rating of Overall Satisfaction
Hide Description Overall satisfaction, as rated by the participant on a 10-point scale, with 1 being very dissatisfied to 10 being very satisfied. The participant rated both eyes together by providing one single rating.
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized participants who satisfied specific Inclusion/Exclusion Criteria, did not sleep overnight in study lenses, and used only the habitual lens care during the study. The actual sample size used in calculating the outcome measure may be smaller due to missing responses and/or visit attendance.
Arm/Group Title AIR OPTIX® COLORS FRESHLOOK® COLORBLENDS
Hide Arm/Group Description:
Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
Overall Number of Participants Analyzed 278 274
Mean (Standard Error)
Unit of Measure: Units on a scale
7.45  (0.17) 6.91  (0.17)
2.Secondary Outcome
Title Positive Purchase Intent
Hide Description As reported on a questionnaire in response to, "Assuming these lenses were at a price you would expect to pay, how likely would you be to purchase these lenses?" The binary 'positive' vs 'negative' response variable was derived from a 5-point Likert scale. Positive purchase intent is reported as the percentage of participants choosing "Definitely would purchase" or "Probably would purchase."
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized participants who satisfied specific Inclusion/Exclusion Criteria, did not sleep overnight in study lenses, and used only the habitual lens care during the study. The actual sample size used in calculating the outcome measure may be smaller due to missing responses and/or visit attendance.
Arm/Group Title AIR OPTIX® COLORS FRESHLOOK® COLORBLENDS
Hide Arm/Group Description:
Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
Overall Number of Participants Analyzed 278 274
Measure Type: Number
Unit of Measure: Percentage of participants
51.7 42.5
Time Frame Adverse Events (AE) were collected for the duration of the study (2 months). AEs were obtained as solicited comments and as observations by the study Investigator.
Adverse Event Reporting Description The analysis population includes all participants/eyes exposed to the study products. 5 participants from Test (AIR OPTIX® COLORS) and 6 participants from Control (FRESHLOOK® COLORBLENDS) were randomized but not exposed to the investigational products. Color selection and/or trial-fitting lenses were not considered study products.
 
Arm/Group Title AIR OPTIX® COLORS FRESHLOOK® COLORBLENDS
Hide Arm/Group Description Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
All-Cause Mortality
AIR OPTIX® COLORS FRESHLOOK® COLORBLENDS
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
AIR OPTIX® COLORS FRESHLOOK® COLORBLENDS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/276 (0.00%)   0/274 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AIR OPTIX® COLORS FRESHLOOK® COLORBLENDS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/276 (0.00%)   0/274 (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
Layout table for Results Point of Contact information
Name/Title: Sharon Thomas, O.D., Sr. Principal Clinical Scientist
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
EMail: alcon.medinfo@alcon.com
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01782482    
Other Study ID Numbers: C-12-003
First Submitted: January 31, 2013
First Posted: February 4, 2013
Results First Submitted: February 18, 2014
Results First Posted: March 28, 2014
Last Update Posted: May 9, 2014