Comparison of Lotrafilcon B Lenses With Different Packaging Solutions

NCT02699684 | Completed Results

• 1 other identifier: CLE270-P001
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Refractive Error

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Satisfying the "no Re-fit" Criteria in Both Eyes

  Overall lens fit was graded by the Investigator on a 5-point scale: -2 (unacceptably tight); -1 (acceptably tight); 0 (optimal fit); +1 (acceptable loose); +2 (unacceptable loose). 'No re-fit' criteria was satisfied if an acceptable or optimal overall lens fit, that was also within one grade of the habitual lens fit value, was achieved.

  Day 30, each product

Secondary Outcomes (2)

• Mean Ex Vivo Total Cholesterol Uptake After 30 Days of Wear

  Day 30, each product

• Change From Insertion in Minimum Protected Area (MPA)

  Hour 0 (Lens Insertion) to Hour 12 on Day 1

Study Arms (2)

AOHG, then AOA

OTHER

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.

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

AOA, then AOHG

OTHER

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.

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

Interventions

Lotrafilcon B contact lenses with EOBO-41 DEVICE

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

Also known as: AIR OPTIX® plus HYDRAGLYDE®, AOHG

AOA, then AOHG; AOHG, then AOA

Lotrafilcon B contact lenses DEVICE

Lotrafilcon B contact lenses packaged with copolymer 845

Also known as: AIR OPTIX® AQUA, AOA

AOA, then AOHG; AOHG, then AOA

Hydrogen peroxide-based lens care solution DEVICE

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

Also known as: AOSEPT® PLUS, CLEAR CARE® PLUS

AOA, then AOHG; AOHG, then AOA

Saline solution for rinsing contact lenses DEVICE

Commercially-available saline solution used as needed

Also known as: Minims®

AOA, then AOHG; AOHG, then AOA

Saline solution for rinsing contact lens case DEVICE

Commercially-available solution used as needed

Also known as: LENS PLUS® OCUPURE™

AOA, then AOHG; AOHG, then 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 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Sr. Global Brand Medical Affairs Lead, GCRA
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Trial Manager, EMEA

  Alcon, A Novartis Division

  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
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: March 4, 2016
• Study Start: May 12, 2016
• Primary Completion: October 20, 2016
• Study Completion: October 20, 2016
• Last Updated: July 2, 2018
• Results First Posted: September 7, 2017

Record last verified: 2017-08