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: NCT01782482
• Other study ID #: C-12-003
• Status: Completed
• Phase: N/A
• First received: January 31, 2013
• Last updated: April 25, 2014
• Start date: February 2013
• Est. completion date: April 2013

Study information

• Verified date: March 2014
• 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 was to evaluate overall satisfaction with AIR OPTIX® COLORS as compared to FRESHLOOK® COLORBLENDS contact lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 574
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Myopia
• Refractive Error
• Refractive Errors

Intervention

Device:
• Lotrafilcon B contact lens with color
Silicone hydrogel contact lens with color
• Phemfilcon A contact lens with color
Hydrogel contact lens with color

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Rating of Overall Satisfaction	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.	Day 7	No
Secondary	Positive Purchase Intent	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."	Day 7	No