DW Evaluation of Lotrafilcon B Lenses in a Modified Design

NCT ID: NCT02157909

Last Updated: 2015-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-07-31

Brief Summary

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.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lotrafilcon B sphere modified design contact lenses

Intervention Type: DEVICE

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.

Group Type: ACTIVE_COMPARATOR

Lotrafilcon B sphere contact lenses

Intervention Type: DEVICE

Interventions

Lotrafilcon B sphere modified design contact lenses

Intervention Type: DEVICE

Lotrafilcon B sphere contact lenses

Intervention Type: DEVICE

Other Intervention Names

AIR OPTIX® AQUA sphere; AOA

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Manager, Vision Care, GCRA

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

C-13-055

Identifier Type: -

Identifier Source: org_study_id