A Comparison of Silicone Hydrogel Contact Lenses: AIR OPTIX® COLORS Versus AIR OPTIX® AQUA

Myopia Clinical Trial

Official title:

A Comparison of Silicone Hydrogel Lenses: Colored Versus Non-Colored

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01635920
• Other study ID #: C-12-004
• Status: Completed
• Phase: N/A
• First received: July 5, 2012
• Last updated: February 18, 2014
• Start date: June 2012
• Est. completion date: August 2012

Study information

• Verified date: February 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 compare the overall fit of AIR OPTIX® COLORS to AIR OPTIX® AQUA contact lenses.

Description:

Eligible participants were randomized at Visit 1 (Screening) to receive 1 of the 2 investigational products (1:1 assignment). Between Visit 1 and Visit 2, participants wore their habitual AIR OPTIX® AQUA lenses. Investigational products were dispensed at Visit 2 (Baseline), after which participants were asked to return for 2 additional visits: Visit 3 (Day 14) and Visit 4 (Day 28).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

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

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

• Successful wear of AIR OPTIX® AQUA soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.

• Willing to sign an Informed Consent form. If under legal age of consent, legally authorized representative must also sign an Informed Consent form.

• 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 (OTC) or prescribed topical ocular medications within 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 that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions.

• Ocular or intra-ocular surgery within the previous 12 months (excluding placement of punctal plugs).

• Use of medications contributing to dry eye or ocular irritation unless on a stable dosing regimen for a minimum of 30 days prior to study entry and able to remain on stable regimen throughout the study.

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

• Other protocol-specified exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Lotrafilcon B contact lens with color
Silicone hydrogel contact lens with color
• Lotrafilcon B contact lens
Silicone hydrogel contact lens

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With Same Fit in Both Eyes	Lens fit was assessed by the investigator for each eye using a biomicroscope (slit lamp), which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight. "Same fit" was defined as an eye that achieved an acceptable or optimal overall lens fit with the study lens, that was also within one grade of the value observed on the same eye with the habitual lens at the baseline visit.	Up to Day 28	No
Secondary	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