DW Evaluation of Lotrafilcon B Lenses in a Modified Design

NCT02157909 | Completed Results

• 1 other identifier: C-13-055
• Study Type: interventional
• Target: 134
• Locations: 0 countries
• Sites: N/A

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

Keywords

Lens fit; contact lenses; myopia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

AOA Modified

EXPERIMENTAL

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

AOA

ACTIVE COMPARATOR

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

Interventions

Lotrafilcon B sphere modified design contact lenses DEVICE

AOA Modified

Lotrafilcon B sphere contact lenses DEVICE

Also known as: AIR OPTIX® AQUA sphere, AOA

AOA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Head Clinical Development, Vision Care, GCRA
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Trial Manager, Vision Care, GCRA

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2014
• First Posted: June 6, 2014
• Study Start: June 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 11, 2015
• Results First Posted: August 11, 2015

Record last verified: 2015-07