DW Evaluation of Lotrafilcon B Lenses in a Modified Design

Daily Wear (DW) Evaluation of Lotrafilcon B in a Modified Design

The purpose of this study is to demonstrate that Lotrafilcon B AIR OPTIX® AQUA sphere modified design lenses are noninferior to Lotrafilcon B AIR OPTIX® AQUA in overall lens fit by comparing the percent of subjects satisfying the "no re-fit" criteria in each treatment group.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Lotrafilcon B sphere modified design contact lenses; Device: Lotrafilcon B sphere contact lenses

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must sign an Informed Consent Document;
• Myopic, wear AIR OPTIX® AQUA lenses in the range of -1.00 to -5.00 diopters (D) in both eyes, and willing to comply with the wearing schedule;
• Manifest cylinder less than or equal to 0.75 D;
• Able to achieve best corrected visual acuity (BCVA) of 20/25 (Snellen) or better in each eye at distance;
• Able to achieve distance visual acuity of at least 20/40 in each eye with habitual and study lenses;
• Wearing spherical AIR OPTIX® AQUA lenses in both eyes for at least 3 months (at least 8 hours per day, at least 5 days per week), wearing the habitual lenses for a minimum of 4 hours prior to the baseline study visit, and achieving an acceptable or optimal fit at baseline visit with habitual lenses in both eyes;
• Other protocol-defined criteria may apply.

Exclusion Criteria:

• Current soft contact lens wearer who regularly sleeps in lenses (1 or more nights per week);
• Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment;
• 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;
• History of herpetic keratitis;
• History of corneal or refractive surgery or irregular cornea;
• A pathologically dry eye that precludes contact lens wear;
• Monocular (only one eye with functional vision);
• Monovision correction;
• History of intolerance or hypersensitivity to any component of the test articles or associated materials;
• Concurrent participation in a contact lens or contact lens care product clinical trial or within the previous 30 days;
• Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment;
• Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the study lenses or affect the results of this study;
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AOA Modified; Lotrafilcon B sphere modified design contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days.	Device: Lotrafilcon B sphere modified design contact lenses
Active Comparator: AOA; Lotrafilcon B sphere contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days.	Device: Lotrafilcon B sphere contact lenses; Other Names: AIR OPTIX® AQUA sphere; AOA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects Satisfying the 'no Re-fit' Criteria in Both Eyes	With the contact lens on eye, the investigator assessed the lens fit immediately post-blink and following lower lid margin push-up with the lower lid using a 5-point scale, where -2 = Unacceptably tight (reduced movement, unacceptable), -1 = Acceptably tight (reduced movement, acceptable), 0 = Optimal fit / movement, +1 = Acceptably loose (excessive movement, acceptable), and +2 = Unacceptably loose (excessive movement, unacceptable). To meet the definition of "no re-fit," an eye had to have an acceptable or optimal overall lens fit with the study lens, as well as be within 1 grade of the overall lens fit assessed with the habitual lens at baseline. Proportion of subjects is reported as a percentage.	Dispense (Day 0), Week 1

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Manager, Vision Care, GCRA, Alcon Research

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: June 4, 2014
• First Submitted That Met QC Criteria: June 5, 2014
• First Posted (Estimate): June 6, 2014

Study Record Updates

• Last Update Posted (Estimate): August 11, 2015
• Last Update Submitted That Met QC Criteria: July 16, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: contact lenses; myopia; Lens fit
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: C-13-055