Clinical trial NCT01699750: Comparative In-Vivo Wetting Characteristics of Silicone Hydrogel Materials With Selected Lens Care Systems
Official title: Comparative In-Vivo Wetting Characteristics of Silicone Hydrogel Materials With Selected Lens Care Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Astigmatism
Refractive Error
Keywords: contact lenses
contact lens solution
myopia
astigmatism
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-10-04
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate the lipid uptake, wetting characteristics, and visual performance of AIR OPTIX® AQUA and ACUVUE® OASYS® with HYDRACLEAR® contact lenses when used in conjunction with two contact lens care systems.

Detailed description: This study will be divided into two phases. In the Pre-Investigational Phase (Phase 1), participants will wear PureVision contact lenses for 30 days and use ReNu® Multiplus® for contact lens care. Eligible participants will continue into the Investigational Phase (Phase 2) and be randomly assigned to wear AIR OPTIX® AQUA contact lenses or ACUVUE® OASYS® with HYDRACLEAR® contact lenses for a total of two months. For contact lens care, participants will use OPTI-FREE® PUREMOIST® MPDS and BIOTRUE® for 30 days each.

Eligibility criteria: Inclusion Criteria:

* Read and understand the Participant Information Sheet;
* Read, sign, and date the Informed Consent;
* Be a current silicone hydrogel contact lens wearer using the contact lenses under a frequent replacement (bi-weekly or monthly) daily wear modality;
* Be classified as symptomatic and a depositor at the end of the replacement period according to protocol-specified criteria;
* Agree to wear study contact lenses as directed for the duration of the study and maintain the appointment schedule;
* Best corrected visual acuity of 6/9 or better in each eye;
* Normal eyes with the exception of the need for visual correction;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Known sensitivity or intolerance to any of the contact lenses or contact lens care products to be used;
* Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses);
* Use of systemic medication which might interfere with contact lens wear or produce dry eye side effects;
* Systemic disease which might interfere with contact lens wear or produce dry eye side effects;
* Systemic or ocular allergies which might interfere with contact lens wear;
* Ocular disease which might interfere with contact lens wear;
* Active ocular infection;
* Use of any concomitant topical ocular medications during the study period;
* Previous ocular surgery;
* Pregnant, planning to become pregnant, or lactating at the time of enrollment;
* Participation in an investigational drug or device study within 30 days of entering this study;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Ex-Vivo Total Lipid Uptake Per Lens
timeFrame: Day 30
Secondary outcomes:
measure: Mean Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT)
timeFrame: Day 30
measure: LogMAR Time-Controlled Visual Acuity (TCVA)
timeFrame: Day 30
measure: Overall Comfort Measured With Visual Analog Scale (VAS)
timeFrame: Day 30
measure: Overall Dryness Measured With Visual Analog Scale (VAS)
timeFrame: Day 30
measure: Average Exposure Speed
timeFrame: Day 30
measure: Minimum Protected Area
timeFrame: Day 30
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center at 1-888-451-3937 for Trial Locations
state: Texas
Study officials:
affiliation: Alcon Research
name: Jami Kern, PhD
role: STUDY_DIRECTOR
References: