Clinical trial NCT01809197: Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution
Official title: Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Myopia
Hyperopia
Astigmatism
Presbyopia
Keywords: Refractive error
Myopia
Hyperopia
Astigmatism
Presbyopia
Contact lenses
Contact lens solution
Comfort
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2013-03-12
Enrollment: 387
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: Prior to the 30-day study period, subjects were fitted with study lenses in a masked manner and underwent a run-in period of 4-8 days to adjust to the randomized lenses.

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.

Primary outcomes:
measure: Likert Scale Questionnaire Item: "I Can Comfortably Wear my Lenses"
timeFrame: Day 30; after 4 hours of lens wear
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Jessie Lemp, PhD
role: STUDY_DIRECTOR
References: