A Comparison of Two Color Contact Lenses in Habitual Clear Contact Lens Wearers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 151
- Primary Endpoint
- Lens Comfort Likert Response at Day 30
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- •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
- •Other protocol-specified exclusion criteria may apply.
Arms & Interventions
AIR OPTIX COLORS
Lotrafilcon B contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
Intervention: Lotrafilcon B contact lenses with color printing (Device)
FreshLook COLORBLENDS
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.
Intervention: Phemfilcon A contact lenses with color printing (Device)
Outcomes
Primary Outcomes
Lens Comfort Likert Response at Day 30
Time Frame: 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.
Secondary Outcomes
- Lens Comfort Likert Response at Day 14(Day 14)
- Lens Comfort 1-10 Scale Response(Day 30)