Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution
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ClinicalTrials.gov Identifier: NCT01809197 |
Recruitment Status
:
Completed
First Posted
: March 12, 2013
Results First Posted
: July 22, 2014
Last Update Posted
: July 22, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Refractive Error Myopia Hyperopia Astigmatism Presbyopia | Device: Lotrafilcon B contact lenses Device: Senofilcon A contact lenses Device: OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS) Device: Habitual Multi-Purpose Solution (MPS) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 387 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Supportive Care |
Official Title: | Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution |
Study Start Date : | April 2013 |
Actual Primary Completion Date : | July 2013 |
Actual Study Completion Date : | July 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Air Optix/OFPM
Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
|
Device: Lotrafilcon B contact lenses
Silicone hydrogel contact lenses for near/far-sightedness, astigmatism, and/or presbyopia, replaced per manufacturer's instructions
Other Names:
Device: OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS)
Multi-purpose disinfecting solution for contact lens care, used per manufacturer's instructions
Other Name: OPTI-FREE® PureMoist™
|
Active Comparator: Acuvue Oasys/Habitual MPS
Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
|
Device: Senofilcon A contact lenses
Silicone hydrogel contact lenses for near/far-sightedness, astigmatism, and/or presbyopia, replaced per manufacturer's instructions
Other Names:
Device: Habitual Multi-Purpose Solution (MPS)
Multi-purpose solution for contact lens care according to subject's habitual brand, used per manufacturer's instructions
|
- Likert Scale Questionnaire Item: "I Can Comfortably Wear my Lenses" [ Time Frame: Day 30; after 4 hours of lens wear ]Response of subject to a questionnaire item using a 5-point Likert scale, where 5=strongly agree and 1=strongly disagree.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809197
Study Director: | Jessie Lemp, PhD | Alcon Research |
Responsible Party: | Alcon Research |
ClinicalTrials.gov Identifier: | NCT01809197 History of Changes |
Other Study ID Numbers: |
M-12-056 |
First Posted: | March 12, 2013 Key Record Dates |
Results First Posted: | July 22, 2014 |
Last Update Posted: | July 22, 2014 |
Last Verified: | June 2014 |
Keywords provided by Alcon Research:
Refractive error Myopia Hyperopia Astigmatism |
Presbyopia Contact lenses Contact lens solution Comfort |
Additional relevant MeSH terms:
Myopia Astigmatism Presbyopia Refractive Errors Hyperopia Eye Diseases |
Pharmaceutical Solutions Salicylic Acid Anti-Infective Agents Antifungal Agents Keratolytic Agents Dermatologic Agents |