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

• 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: Alcon Research
• Information provided by (Responsible Party): Alcon Research

Study Description

Brief Summary:

The purpose of this study was to evaluate overall satisfaction with AIR OPTIX® COLORS as compared to FRESHLOOK® COLORBLENDS contact lenses.

Condition or disease	Intervention/treatment	Phase
Myopia; Refractive Error	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: 574 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Official Title: A Comparison of Two Color Contact Lenses in Habitual Clear Contact Lens Wearers
• Study Start Date: February 2013
• Actual Primary Completion Date: April 2013
• Actual Study Completion Date: April 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: AIR OPTIX® COLORS; 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.	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 on a daily wear basis for 7 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 Satisfaction [ Time Frame: Day 7 ]
   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.

Secondary Outcome Measures :

1. Positive Purchase Intent [ Time Frame: Day 7 ]
   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."

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:

• Willing and able to sign Informed Consent Document. If under legal age of consent, legally authorized representative must also sign Informed Consent Document.
• Able to achieve best corrected visual acuity (BCVA) of 20/25 (Snellen) or better in each eye at distance.
• Manifest cylinder less than or equal to 0.75 diopter in each eye.
• Wear contact lenses within protocol-defined specifications.
• Require spherical contact lenses within the available range of powers.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Any eye condition that contraindicates contact lens wear.
• Any systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
• Moderate or severe ocular findings upon examination.
• Any use of systemic or ocular medications that could contraindicate contact lens wear, including use of topical ocular medications requiring instillation during contact lens wear, except for approved lubricating drops.
• Habitual lenses worn in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week or more) over the last 3 months prior to enrollment.
• Previous corneal or refractive surgery or irregular cornea.
• Eye injury or surgery within the last 6 months (excluding placement of punctal plugs).
• Monovision and monocular subjects (only one eye with functional vision) or subjects fit with only one lens.
• History of intolerance or hypersensitivity to any component of the test articles.
• 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: NCT01782482
• Other Study ID Numbers: C-12-003
• First Posted: February 4, 2013
• Results First Posted: March 28, 2014
• Last Update Posted: May 9, 2014
• Last Verified: March 2014

Keywords provided by Alcon Research:

Color contact lenses; Refractive error; Myopia

Additional relevant MeSH terms:

Myopia; Refractive Errors; Eye Diseases