N/A
N=198
Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 1
Myopia · Hyperopia · Contact Lens Comfort
Bottom Line
View on ClinicalTrials.gov: NCT01684033 ↗Enrolled (actual)
198
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Corneal Staining — 1.9; 2.8 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Opti-Free® PureMoist® MPDS (Device); Biotrue™ MPS (Device); Habitual contact lenses (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Corneal Staining |
1.9; 2.8 | — |
| PRIMARY Change From Baseline in Corneal Staining at Day 30 |
0.7; 1.6 | — |
Summary
The purpose of this study was to evaluate the performance of Opti-Free® PureMoist® Multi-Purpose Disinfecting Solution (MPDS) compared to Biotrue™ Multipurpose Solution (MPS) in silicone hydrogel contact lens wearers.
Eligibility Criteria
Inclusion Criteria
- Wear single vision sphere silicone hydrogel contact lenses (CooperVision™ Biofinity®, Alcon® Air Optix® Aqua, Bausch+Lomb® PureVision™ or ACUVUE® Oasys™) on a daily wear basis (a minimum of 8 hours per day, 5 days a week) for at least one month prior to Visit 1;
- Willing to wear lenses on a daily wear basis (a minimum of 8 hours per day, 5 days a week) for the duration of the study, and wear lenses for 16 hours on two days during the study;
- Must have habitually used a Biguanide preserved multi-purpose solution (other than Biotrue) for at least 30 days prior to Visit 1;
- Vision correctable to 20/30 Snellen (feet) or better in each eye at distance with pre-study contact lenses at Visit 1;
- Have access, capability and willingness to review and answer text messages;
- Read, sign, and date IRB/IEC approved informed consent and privacy document before enrollment;
- Willing to follow the study procedures and visit schedule;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Need to wear lenses on an extended wear (i.e. overnight) basis during the study;
- Known sensitivity or intolerance to Biguanide, polyquaternium-1 (POLYQUAD), or ALDOX preserved lens care products;
- Monocular (only one eye with functional vision) or fit with only one lens;
- Wearing toric or multifocal contact lenses or fit with monovision;
- Use of additional lens care products other than a Biguanide preserved multipurpose solution such as daily or enzyme cleaners within the one week prior to Visit 1;
- Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications, with the exception of rewetting drops, within 7 days prior to Visit 1;
- Abnormal ocular condition observed during the Visit 1 slit-lamp examination;
- Current or history of ocular infections or severe inflammation within 6 months prior to Visit 1;
- Ocular surgery within the 12 months prior to Visit 1;
- Participation in any other clinical trial within 30 days of enrollment;
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01684033). 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.