Status:
COMPLETED
Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution
Lead Sponsor:
Alcon Research
Conditions:
Refractive Error
Myopia
Eligibility:
All Genders
18+ years
Phase:
NA
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® ...
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
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
387 Patients enrolled
Trial Details
Trial ID
NCT01809197
Start Date
April 1 2013
End Date
July 1 2013
Last Update
July 22 2014
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