A Comparison of AIR OPTIX® COLORS Versus FRESHLOOK® COLORBLENDS
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|ClinicalTrials.gov Identifier: NCT01635933|
Recruitment Status : Completed
First Posted : July 10, 2012
Results First Posted : March 28, 2014
Last Update Posted : May 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Myopia||Device: Lotrafilcon B contact lens with color Device: Phemfilcon A contact lens with color||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||370 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Comparison of a Colored Silicone Hydrogel Lens Versus a Colored HEMA Lens|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
Experimental: AIR OPTIX® COLORS
Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
Device: Lotrafilcon B contact lens with color
Silicone hydrogel contact lens with color.
Other Name: AIR OPTIX® COLORS
Active Comparator: FRESHLOOK® COLORBLENDS
Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
Device: Phemfilcon A contact lens with color
Hydrogel contact lens with color.
Other Name: FRESHLOOK® COLORBLENDS
- Subjective Rating of Overall Comfort [ Time Frame: Up to Day 28 ]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 Vision [ Time Frame: Up to Day 28 ]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.
- Proportion of Subjects Preferring Study Lens (Strongly or Somewhat) [ Time Frame: Day 28 ]Participants were asked to compare the study lenses to their habitual lenses using a 5-point scale: strongly prefer study lenses, somewhat prefer study lenses, no preference, somewhat prefer habitual lenses, and strongly prefer habitual lenses, where 'study lenses' refer to either test or control depending on the treatment group. Proportion of subjects preferring study lens is reported as the percentage of participants who strongly or somewhat preferred the study lens.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01635933
|Study Director:||Sharon Holden Thomas, O.D.||Alcon Research|