Comparison of Lotrafilcon B Lenses With Different Packaging Solutions

Refractive Error Clinical Trial

Official title:

One Month Clinical Comparison of Two Lotrafilcon B Spherical Lenses With Different Packaging Solutions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02699684
• Other study ID #: CLE270-P001
• Status: Completed
• Phase: N/A
• Start date: May 12, 2016
• Est. completion date: October 20, 2016

Study information

• Verified date: August 2017
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: October 20, 2016
• Est. primary completion date: October 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• Lotrafilcon B contact lenses with EOBO-41
Lotrafilcon B contact lenses packaged with copolymer 845 and EOBO-41
• Lotrafilcon B contact lenses
Lotrafilcon B contact lenses packaged with copolymer 845
• Hydrogen peroxide-based lens care solution
Commercially-available hydrogen peroxide-based lens care solution for cleaning, disinfecting, and storing silicone hydrogel soft contact lenses
• Saline solution for rinsing contact lenses
Commercially-available saline solution used as needed
• Saline solution for rinsing contact lens case
Commercially-available solution used as needed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean Ex Vivo Total Cholesterol Uptake After 30 Days of Wear	The contact lens was removed from the eye. Cholesterol deposits were extracted and measured in micrograms (µg) per lens. Lower deposits indicate increased lens performance. Only one eye (right eye) contributed to the analysis.	Day 30, each product
Secondary	Change From Insertion in Minimum Protected Area (MPA)	MPA (the minimum area of the contact lens surface (expressed in %) protected by the tear film between two natural blinks) was assessed by the Investigator during the interblink period using the Tearscope® lighting system. Higher values indicate a more stable tear film in front of the lens. This Outcome Measure was pre-specified for AOHG only. Both eyes contributed to the analysis.	Hour 0 (Lens Insertion) to Hour 12 on Day 1

External Links

•   Results from the Novartis Clinical Trial Results Website