Comparison of Lotrafilcon B Lenses With Different Packaging Solutions

Alcon

Status: Completed

Conditions: Refractive Error

Treatments: Device: Saline solution for rinsing contact lenses; Device: Lotrafilcon B contact lenses with EOBO-41; Device: Saline solution for rinsing contact lens case; Device: Hydrogen peroxide-based lens care solution; Device: Lotrafilcon B contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT02699684

CLE270-P001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;
• Other protocol-specified inclusion criteria may apply.

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;
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

82 participants in 2 patient groups

AOHG, then AOA

Other group

Description:

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.

Treatment:

Device: Lotrafilcon B contact lenses

Device: Saline solution for rinsing contact lens case

Device: Hydrogen peroxide-based lens care solution

Device: Lotrafilcon B contact lenses with EOBO-41

Device: Saline solution for rinsing contact lenses

AOA, then AOHG

Other group

Description:

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.

Treatment:

Device: Lotrafilcon B contact lenses

Device: Saline solution for rinsing contact lens case

Device: Hydrogen peroxide-based lens care solution

Device: Lotrafilcon B contact lenses with EOBO-41

Device: Saline solution for rinsing contact lenses