Subjective Evaluation of a Commercially Marketed Contact Lens Amongst a Subset of the Contact Lens Wearing Population

The purpose of this study is to compare the performance of commercially marketed contact lenses to habitual contact lenses in a selected segment of the contact lens wearing population.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Lotrafilcon B contact lens; Device: Habitual contact lens

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Habitual spherical soft contact lens wearer who wears a contact lens with a recommended replacement schedule of 2 weeks or monthly.
• Wears lenses at least 5 days per week and at least 12 hours per day.
• Removes contact lenses daily or, if prescribed by their regular eye care practitioner, sleeps overnight in contact lenses no more than 6 consecutive nights.
• Reports 2 or fewer common lens-related symptoms with current contact lenses with a frequency of "frequently" or "always".
• Able to achieve distance visual acuity of at least 20/40 in each eye at the dispense of each pair of study lenses.
• Has acceptable or optimal fit for each eye at the dispense of each pair of study lenses.
• Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

• Eye injury or surgery within twelve weeks prior to enrollment.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Currently enrolled in any clinical trial.
• Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
• Currently sleeping in contact lenses for more than 6 consecutive nights.
• Currently wearing daily disposable contact lenses and certain protocol-specified lens brands.
• Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lotrafilcon B / Habitual; Lotrafilcon B contact lenses worn first, with habitual contact lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.	Device: Lotrafilcon B contact lens; Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of monthly.; Device: Habitual contact lens; Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.
Other: Habitual / Lotrafilcon B; Habitual contact lenses worn first, with lotrafilcon B lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.	Device: Lotrafilcon B contact lens; Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of monthly.; Device: Habitual contact lens; Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort Upon Insertion	Comfort upon insertion, as interpreted by the participant, was recorded on a questionnaire by the participant using a 10-point scale, with 1 being poor and 10 being excellent. Comfort upon insertion was assessed as a single, retrospective evaluation of 4-weeks' wear time.	4 weeks of wear

Collaborators and Investigators

• Sponsor: CIBA VISION

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: November 2, 2009
• First Submitted That Met QC Criteria: November 3, 2009
• First Posted (Estimate): November 5, 2009

Study Record Updates

• Last Update Posted (Estimate): July 10, 2012
• Last Update Submitted That Met QC Criteria: June 26, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: P-336-C-016