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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01809197
First received: March 8, 2013
Last updated: June 20, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to compare comfort between two systems of contact lens+contact lens care.


Condition Intervention
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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Likert Item: "I can comfortably wear my lenses" [ Time Frame: Day 30 ] [ Designated as safety issue: No ]

Enrollment: 368
Study Start Date: April 2013
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lotrafilcon B/OPTI-FREE
Lotrafilcon B contact lenses 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:
  • AIR OPTIX® AQUA
  • AIR OPTIX® AQUA Multifocal
  • AIR OPTIX® for Astigmatism
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: Senofilcon A/Habitual MPS
Senofilcon A contact lenses 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:
  • ACUVUE® OASYS® with HYDRACLEAR® PLUS
  • ACUVUE® OASYS® for ASTIGMATISM with HYDRACLEAR® PLUS
  • ACUVUE® OASYS® for PRESBYOPIA with HYDRACLEAR® PLUS
Device: Habitual Multi-Purpose Solution (MPS)
Multi-purpose solution for contact lens care according to participant's habitual brand, used per manufacturer's instructions

Detailed Description:

Prior to the 30-day study period, participants will be fitted with study lenses in a masked manner and undergo a run-in period of 4-8 days to adjust to the randomized lenses.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 any Air Optix or Acuvue brand of silicone hydrogel contact 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01809197

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Jessie Lemp, MS Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01809197     History of Changes
Other Study ID Numbers: M-12-056
Study First Received: March 8, 2013
Last Updated: June 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Refractive error
Myopia
Hyperopia
Astigmatism
Presbyopia
Contact lenses
Contact lens solution
Comfort

Additional relevant MeSH terms:
Astigmatism
Hyperopia
Myopia
Presbyopia
Refractive Errors
Eye Diseases
Contact Lens Solutions
Disinfectants
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014