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OpenTrials
Completed

NCT Number: NCT01809197

Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lotrafilcon B contact lenses

Device

Silicone hydrogel contact lenses for near/far-sightedness, astigmatism, and/or presbyopia, replaced per manufacturer's instructions

Other names: AIR OPTIX® AQUA, AIR OPTIX® AQUA Multifocal, AIR OPTIX® for Astigmatism

Senofilcon A contact lenses

Device

Silicone hydrogel contact lenses for near/far-sightedness, astigmatism, and/or presbyopia, replaced per manufacturer's instructions

Other names: ACUVUE® OASYS® with HYDRACLEAR® PLUS, ACUVUE® OASYS® for ASTIGMATISM with HYDRACLEAR® PLUS, ACUVUE® OASYS® for PRESBYOPIA with HYDRACLEAR® PLUS

OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS)

Device

Multi-purpose disinfecting solution for contact lens care, used per manufacturer's instructions

Other names: OPTI-FREE® PureMoist™

Habitual Multi-Purpose Solution (MPS)

Device

Multi-purpose solution for contact lens care according to subject's habitual brand, used per manufacturer's instructions

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 12, 2013
Registry last updated
Jul 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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