N/A
N=372
Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution
Refractive Error · Myopia · Hyperopia · Astigmatism · Presbyopia
Bottom Line
View on ClinicalTrials.gov: NCT01809197 ↗Enrolled (actual)
372
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Likert Scale Questionnaire Item: "I Can Comfortably Wear my Lenses" — 4.2; 4.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lotrafilcon B contact lenses (Device); Senofilcon A contact lenses (Device); OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS) (Device); Habitual Multi-Purpose Solution (MPS) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Likert Scale Questionnaire Item: "I Can Comfortably Wear my Lenses" |
4.2; 4.4 | — |
Summary
The purpose of this study was to compare lens comfort on Day 30 for Air Optix® lenses cared for with OPTI-FREE® PureMoist® (OFPM) Multi Purpose Disinfecting Solution (MPDS) compared to Acuvue® Oasys® lenses cared for with habitual MPDS.
Eligibility Criteria
Inclusion Criteria
- Sign informed consent.
- Currently wearing weekly/monthly contact lenses on a daily wear basis, as specified in protocol.
- Willing to wear contact lenses on a daily wear basis for the duration of the study.
- Currently using a multi-purpose solution, as specified in protocol.
- Vision correctable to 20/30 (Snellen) or better in each eye at distance at Visit 1.
- Willing to follow the study procedures and visit schedule.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Currently wearing Air Optix, Acuvue Oasys, or Acuvue Advance brand of lenses.
- Currently using any Opti-Free brand of multi-purpose solution.
- Must wear contact lenses on an extended wear (overnight) basis during the study.
- Known sensitivity or intolerance to POLYQUAD® or ALDOX preserved lens care products.
- Monocular (only one eye with functional vision), fit with only one lens, or monovision modality of wear.
- Use of additional lens care products other than a multi-purpose solution within 7 days prior to Visit 1.
- Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications, with the exception of contact lens rewetting drops, within 7 days prior to Visit 1.
- Any abnormal ocular condition observed during the Visit 1 slit-lamp examination.
- Current or history of ocular infections (i.e., microbial keratitis, conjunctivitis) or severe inflammation (i.e., iritis, infiltrates) within the 6 months prior to Visit 1.
- Ocular surgery within the 12 months prior to Visit 1.
- Any systemic diseases at Visit 1 (including allergies, respiratory infections or colds) that affect the eye and could be exacerbated by use of contact lenses or contact lens solutions.
- Participation in any clinical study within 30 days of Visit 1.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01809197). 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.