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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02175199
• Other study ID #: M-14-008
• Status: Completed
• Phase: N/A
• First received: June 24, 2014
• Last updated: September 14, 2015
• Start date: June 2014
• Est. completion date: September 2014

Study information

• Verified date: September 2015
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 1.

• Other protocol-specified exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Lotrafilcon B contact lenses with color printing

• Phemfilcon A contact lenses with color printing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Lens Comfort Likert Response at Day 14	Subject indicated agreement with the following statement, "These lenses provided the same excellent comfort at the end of two weeks as they did at the beginning of the two weeks" 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 is prespecified for the AIR OPTIX COLORS arm only.	Day 14	No
Secondary	Lens Comfort 1-10 Scale Response	Subject was instructed, "Please rate your comfort with the study lenses," using a scale from 1-10, where 1=poor and 10=excellent. Both eyes were rated together.	Day 30	No