Comparative In-Vivo Wetting Characteristics of Silicone Hydrogel Materials With Selected Lens Care Systems
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/30/2013 |
Start Date: | November 2012 |
End Date: | November 2013 |
Contact: | Alcon Call Center |
Phone: | 1-888-451-3937 |
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, OPTI-FREE® PUREMOIST® MPDS and
BIOTRUE®.
This study will be divided into two phases, a pre-investigational screening phase and an
investigational phase. During the pre-investigational screening phase, all participants will
use PureVision contact lenses and ReNu Multiplus multipurpose solution per manufacturers'
guidelines for 30 days. Eligible participants will continue into the investigational phase
and will be randomly assigned to wear Air Optix Aqua or Oasys lenses with two months
randomized crossover of contact lens care (one month each of Opti-Free PureMoist MPDS and
Biotrue MPS).
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.
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