N/A
N=70
Comparative In-Vivo Wetting Characteristics of Silicone Hydrogel Materials With Selected Lens Care Systems
Myopia · Astigmatism · Refractive Error
Bottom Line
View on ClinicalTrials.gov: NCT01699750 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Mean Ex-Vivo Total Lipid Uptake Per Lens — 7.198; 35.879 micrograms
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lotrafilcon B contact lenses (Device); Senofilcon A contact lenses (Device); OPTI-FREE® PUREMOIST® MPDS (Device); BIOTRUE® (Device); Balafilcon A contact lenses (Device); ReNu® Multiplus® (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Ex-Vivo Total Lipid Uptake Per Lens |
7.198; 35.879 | — |
| SECONDARY Mean Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT) |
3.316; 2.918 | — |
| SECONDARY LogMAR Time-Controlled Visual Acuity (TCVA) |
0.38; -0.14; -1.15; -1.60 | — |
| SECONDARY Overall Comfort Measured With Visual Analog Scale (VAS) |
77.1; 81.1; 74.9; 82.2 | — |
| SECONDARY Overall Dryness Measured With Visual Analog Scale (VAS) |
21.8; 22.2; 23.3; 22.5 | — |
| SECONDARY Average Exposure Speed |
0.059; 0.105 | — |
| SECONDARY Minimum Protected Area |
90.75; 77.79 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01699750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.