Comparison of Lotrafilcon B Lenses With Different Packaging Solutions

NCT ID: NCT02699684

Last Updated: 2018-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-12
• Study Completion Date: 2016-10-20

Brief Summary

The purpose of this study is to evaluate AIR OPTIX® plus HYDRAGLYDE® (AOHG) contact lenses compared to AIR OPTIX® AQUA (AOA) contact lenses in overall lens fit.

Detailed Description

Subjects must not wear any contact lenses prior to the visit on Day 1 (Insertion) for Period 1 or Day 1 (Insertion) for Period 2.

Conditions

Refractive Error

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

AOHG, then AOA

Lotrafilcon B contact lenses with EOBO-41 worn first, followed by lotrafilcon B contact lenses worn second. Both products worn bilaterally (in both eyes) for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.

Group Type: OTHER

Lotrafilcon B contact lenses with EOBO-41

Intervention Type: DEVICE

Lotrafilcon B contact lenses packaged with copolymer 845 and EOBO-41

Lotrafilcon B contact lenses

Intervention Type: DEVICE

Lotrafilcon B contact lenses packaged with copolymer 845

Hydrogen peroxide-based lens care solution

Intervention Type: DEVICE

Commercially-available hydrogen peroxide-based lens care solution for cleaning, disinfecting, and storing silicone hydrogel soft contact lenses

Saline solution for rinsing contact lenses

Intervention Type: DEVICE

Commercially-available saline solution used as needed

Saline solution for rinsing contact lens case

Intervention Type: DEVICE

Commercially-available solution used as needed

AOA, then AOHG

Lotrafilcon B contact lenses worn first, followed by lotrafilcon B contact lenses with EOBO-41 worn second. Both products worn bilaterally for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.

Group Type: OTHER

Lotrafilcon B contact lenses with EOBO-41

Intervention Type: DEVICE

Lotrafilcon B contact lenses packaged with copolymer 845 and EOBO-41

Lotrafilcon B contact lenses

Intervention Type: DEVICE

Lotrafilcon B contact lenses packaged with copolymer 845

Hydrogen peroxide-based lens care solution

Intervention Type: DEVICE

Commercially-available hydrogen peroxide-based lens care solution for cleaning, disinfecting, and storing silicone hydrogel soft contact lenses

Saline solution for rinsing contact lenses

Intervention Type: DEVICE

Commercially-available saline solution used as needed

Saline solution for rinsing contact lens case

Intervention Type: DEVICE

Commercially-available solution used as needed

Interventions

Lotrafilcon B contact lenses with EOBO-41

Lotrafilcon B contact lenses packaged with copolymer 845 and EOBO-41

Intervention Type: DEVICE

Lotrafilcon B contact lenses

Lotrafilcon B contact lenses packaged with copolymer 845

Intervention Type: DEVICE

Hydrogen peroxide-based lens care solution

Commercially-available hydrogen peroxide-based lens care solution for cleaning, disinfecting, and storing silicone hydrogel soft contact lenses

Intervention Type: DEVICE

Saline solution for rinsing contact lenses

Commercially-available saline solution used as needed

Intervention Type: DEVICE

Saline solution for rinsing contact lens case

Commercially-available solution used as needed

Intervention Type: DEVICE

Other Intervention Names

AIR OPTIX® plus HYDRAGLYDE®; AOHG; AIR OPTIX® AQUA; AOA; AOSEPT® PLUS; CLEAR CARE® PLUS; Minims®; LENS PLUS® OCUPURE™

Eligibility Criteria

Inclusion Criteria

• Must sign Informed Consent Document;
• Manifest cylinder less than or equal to 0.75 Diopter (D) in each eye;
• Successful current wearer (during the past 2 months for a minimum of 5 days per week and 8 hours per day) of AOA contact lenses within the protocol-specified power range;
• Willing to answer text messages on a daily basis during the study;
• Willing to discontinue artificial tears and rewetting drops on the days of study visits;

Exclusion Criteria

• Habitual lens wear in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week);
• Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current);
• History of herpetic keratitis, corneal surgery or irregular cornea;
• Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
• Monocular (only 1 eye with functional vision) or fit with only 1 lens;
• Pregnant or lactating;
• Participation in any clinical study within 30 days of Visit 1;

• 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, EMEA

Role: STUDY_DIRECTOR

Alcon, A Novartis Division

Other Identifiers

CLE270-P001

Identifier Type: -

Identifier Source: org_study_id