A Comparison of AIR OPTIX® COLORS Versus FRESHLOOK® COLORBLENDS

• ClinicalTrials.gov Identifier: NCT01635933
• Recruitment Status: Completed
• First Posted: July 10, 2012
• Results First Posted: March 28, 2014
• Last Update Posted: May 9, 2014
• Sponsor: Alcon Research
• Information provided by (Responsible Party): Alcon Research

Study Description

Brief Summary:

The purpose of this study was to evaluate the overall comfort of AIR OPTIX® COLORS compared to FRESHLOOK® COLORBLENDS in habitual wearers of the FRESHLOOK® COLORBLENDS .

Condition or disease	Intervention/treatment	Phase
Myopia	Device: Lotrafilcon B contact lens with color; Device: Phemfilcon A contact lens with color	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 370 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• 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

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Able and willing to sign the Informed Consent document. If under legal age of consent, legally authorized representative must sign also Informed Consent document.
• Able to achieve visual acuity of at least 20/30 (Snellen) in each eye at distance with contact lenses and best corrected visual acuity (BCVA) ≥ 20/25 in each eye.
• Manifest cylinder less than or equal to 0.75 diopters (within the previous year) in each eye.
• Successful wear of FRESHLOOK® COLORBLENDS spherical soft contact lenses in both eyes (in the protocol-specified colors) during the past three months for a minimum of 5 days per week and 8 hours per day.
• History of at least 5 days of successful use with both lenses (minimum of 8 hours/day) of one of the protocol-specified lens care solutions/multi-purpose solutions (MPS).
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of this study.
• Wears habitual lenses in an extended wear modality (sleeping in lenses overnight / not removing lenses on a daily basis).
• Monovision, monocular (only one eye with functional vision) or fit with only one lens.
• History of intolerance or hypersensitivity to any component of the test articles.
• Use of any over-the-counter or prescribed topical ocular medications within the previous 7 days (excluding rewetting drops).
• Moderate or severe corneal edema, corneal vascularization, corneal staining, injection, tarsal abnormalities, "other" complications; and any corneal infiltrates.
• Current or history of ocular infection, severe inflammation, or disease within previous 6 months.
• Any systemic disease (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions.
• Participation in any investigational clinical study within previous 30 days.
• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Sponsors and Collaborators

Alcon Research

Investigators

• Study Director: Sharon Holden Thomas, O.D.; Alcon Research

More Information

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01635933
• Other Study ID Numbers: C-12-005
• First Posted: July 10, 2012
• Results First Posted: March 28, 2014
• Last Update Posted: May 9, 2014
• Last Verified: April 2014

Keywords provided by Alcon Research:

contact lenses; color contact lenses; myopia

Additional relevant MeSH terms:

Myopia; Refractive Errors; Eye Diseases