Overview

This trial has been completed.

Condition refractive error
Treatments lotrafilcon b contact lenses with hydraglyde, lotrafilcon b contact lenses, aosept® plus cleaning and disinfecting solution, minims® saline solution
Sponsor Alcon Research
Start date May 2016
End date October 2016
Trial size 82 participants
Trial identifier NCT02699684, CLE270-P001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, investigator)
Arm
(Other)
Lotrafilcon B contact lenses with hydraglyde worn first, followed by lotrafilcon B contact lenses worn second. Both products worn bilaterally (in both eyes) for 30 days. The lenses will be removed every night during the treatment periods and cared for using AOSEPT® Plus and Minims® saline, according to the instructions for use.
lotrafilcon b contact lenses with hydraglyde AIR OPTIX® plus HYDRAGLYDE® (AOHG)
Lotrafilcon B contact lenses with HydraGlyde® added to the packaging solution containing copolymer 845
lotrafilcon b contact lenses AIR OPTIX® AQUA (AOA)
Lotrafilcon B contact lenses without HydraGlyde® added to the packaging solution containing copolymer 845
aosept® plus cleaning and disinfecting solution AOSEPT® PLUS
Commercially-available hydrogen peroxide-based lens care solution for cleaning, disinfecting, and storing silicone hydrogel soft contact lenses
minims® saline solution
Commercially-available 0.9% saline solution used for rinsing contact lenses
(Other)
Lotrafilcon B contact lenses worn first, followed by lotrafilcon B contact lenses with hydraglyde worn second. Both products worn bilaterally for 30 days. The lenses will be removed every night during the treatment periods and cared for using AOSEPT® Plus and Minims® saline, according to the instructions for use.
lotrafilcon b contact lenses with hydraglyde AIR OPTIX® plus HYDRAGLYDE® (AOHG)
Lotrafilcon B contact lenses with HydraGlyde® added to the packaging solution containing copolymer 845
lotrafilcon b contact lenses AIR OPTIX® AQUA (AOA)
Lotrafilcon B contact lenses without HydraGlyde® added to the packaging solution containing copolymer 845
aosept® plus cleaning and disinfecting solution AOSEPT® PLUS
Commercially-available hydrogen peroxide-based lens care solution for cleaning, disinfecting, and storing silicone hydrogel soft contact lenses
minims® saline solution
Commercially-available 0.9% saline solution used for rinsing contact lenses

Primary Outcomes

Measure
Proportion of subjects satisfying the "no re-fit" criteria in both eyes
time frame: Day 30, each product

Secondary Outcomes

Measure
Mean ex vivo total cholesterol uptake after 30 days of wear
time frame: Day 30, each product
Change from insertion in Minimum Protected Area (MPA)
time frame: Hour 0 to Hour 12 on Day 1
Mean Change from Day 1 in Overall Daily Comfort
time frame: Up to Day 30
Pre-lens Tear Film MPA at Hour 12 on Day 1
time frame: Day 1 at Hour 12, each product

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title One Month Clinical Comparison of Two Lotrafilcon B Spherical Lenses With Different Packaging Solutions
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. This study will be conducted in the United Kingdom.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Alcon Research.