A Comparison of AIR OPTIX® COLORS Versus FRESHLOOK® COLORBLENDS

Myopia Clinical Trial

Official title:

A Comparison of a Colored Silicone Hydrogel Lens Versus a Colored HEMA Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01635933
• Other study ID #: C-12-005
• Status: Completed
• Phase: N/A
• First received: July 5, 2012
• Last updated: April 25, 2014
• Start date: June 2012
• Est. completion date: September 2012

Study information

• Verified date: April 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 the overall comfort of AIR OPTIX® COLORS compared to FRESHLOOK® COLORBLENDS in habitual wearers of the FRESHLOOK® COLORBLENDS .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Able and willing to sign the Informed Consent document. If under legal age of consent, legally authorized representative must sign also Informed Consent document.

• Able to achieve visual acuity of at least 20/30 (Snellen) in each eye at distance with contact lenses and best corrected visual acuity (BCVA) = 20/25 in each eye.

• Manifest cylinder less than or equal to 0.75 diopters (within the previous year) in each eye.

• Successful wear of FRESHLOOK® COLORBLENDS spherical soft contact lenses in both eyes (in the protocol-specified colors) during the past three months for a minimum of 5 days per week and 8 hours per day.

• History of at least 5 days of successful use with both lenses (minimum of 8 hours/day) of one of the protocol-specified lens care solutions/multi-purpose solutions (MPS).

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of this study.

• Wears habitual lenses in an extended wear modality (sleeping in lenses overnight / not removing lenses on a daily basis).

• Monovision, monocular (only one eye with functional vision) or fit with only one lens.

• History of intolerance or hypersensitivity to any component of the test articles.

• Use of any over-the-counter or prescribed topical ocular medications within the previous 7 days (excluding rewetting drops).

• Moderate or severe corneal edema, corneal vascularization, corneal staining, injection, tarsal abnormalities, "other" complications; and any corneal infiltrates.

• Current or history of ocular infection, severe inflammation, or disease within previous 6 months.

• Any systemic disease (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions.

• Participation in any investigational clinical study within previous 30 days.

• Other protocol-defined 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 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 Comfort	Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.	Up to Day 28	No
Secondary	Subjective Rating of Overall Vision	Overall vision, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.	Up to Day 28	No
Secondary	Proportion of Subjects Preferring Study Lens (Strongly or Somewhat)	Participants were asked to compare the study lenses to their habitual lenses using a 5-point scale: strongly prefer study lenses, somewhat prefer study lenses, no preference, somewhat prefer habitual lenses, and strongly prefer habitual lenses, where 'study lenses' refer to either test or control depending on the treatment group. Proportion of subjects preferring study lens is reported as the percentage of participants who strongly or somewhat preferred the study lens.	Day 28	No