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

NCT02175199 | Completed Results

• 1 other identifier: M-14-008
• Study Type: interventional
• Target: 151
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the comfort of color contact lenses in a population of clear contact lens wearers who have an interest in wearing color contact lenses.

Conditions

Myopia

Keywords

Contact lens; Vision care; Daily wear; Color contact lens

Outcome Measures

Primary Outcomes (1)

• Lens Comfort Likert Response at Day 30

  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.

  Day 30

Secondary Outcomes (2)

• Lens Comfort Likert Response at Day 14

  Day 14

• Lens Comfort 1-10 Scale Response

  Day 30

Study Arms (2)

AIR OPTIX COLORS

EXPERIMENTAL

Lotrafilcon B contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.

Device: Lotrafilcon B contact lenses with color printing

FreshLook COLORBLENDS

ACTIVE COMPARATOR

Phemfilcon A 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.

Device: Phemfilcon A contact lenses with color printing

Interventions

Lotrafilcon B contact lenses with color printing DEVICE

Also known as: AIR OPTIX® COLORS

AIR OPTIX COLORS

Phemfilcon A contact lenses with color printing DEVICE

Also known as: FreshLook® COLORBLENDS®

FreshLook COLORBLENDS

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to sign an Informed Consent Document or Assent, if applicable.
• Vision correctable to 20/30 Snellen (feet) or better in each eye at distance with pre-study contact lenses.
• Manifest cylinder (at screening) less than or equal to 0.75 diopters (D) in each eye.
• Successful wear of clear/handling tint, single-vision spherical, bi-weekly/ monthly replacement soft contact lenses in both eyes during the past 2 months for a minimum of 5 days per week and 8 hours per day.
• Requires spherical contact lenses within the available range of powers (i.e.,-1.50D to -5.00D in 0.25D steps).
• Interested in wearing contact lenses that change the appearance of the color of the eyes.

You may not qualify if:

• Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current).
• History of herpetic keratitis.
• Any use of systemic or ocular medications for which contact lens wear could be contraindicated including any use of topical ocular medications that would require instillation during contact lens wear, except for rewetting drops.
• Corneal vascularization greater than 1 millimeter (mm) of penetration.
• 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.
• Monovision and monocular (only 1 eye with functional vision) or fit with only 1 lens.
• Anisometropia ≥1.50D (study contact lens prescription).
• History of intolerance or hypersensitivity to any component of the test articles.
• Eye injury or ocular or intra-ocular surgery within the last 6 months (excluding placement of punctal plugs).
• Participation in any clinical study within 30 days of Visit 1.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Global Brand Lead, GCRA, Vision Care
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Global Brand Lead, GCRA, Vision Care

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 26, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 14, 2015
• Results First Posted: October 14, 2015

Record last verified: 2015-09